NCT02834780 is a Phase 1 clinical trial of H3B-6527 in Advanced Hepatocellular Carcinoma, sponsored by H3 Biomedicine Inc..

Who is sponsoring NCT02834780?

NCT02834780 is sponsored by H3 Biomedicine Inc..

What drugs are being tested in NCT02834780?

Interventions in NCT02834780: H3B-6527.

What condition does NCT02834780 study?

NCT02834780 studies Advanced Hepatocellular Carcinoma, Hepatocellular Carcinoma, Liver Cancer, Liver Neoplasms, Hepatic Cancer, Hepatic Carcinoma.

Is NCT02834780 still recruiting?

NCT02834780 is currently completed. Last updated 13 November 2023.

Are results published for NCT02834780?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-11-13 · How we verify

NCT02834780

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B-6527 in Participants With Advanced Hepatocellular Carcinoma

Completed Phase 1 Results posted Last updated 13 November 2023

What this trial tests

Phase 1 trial testing H3B-6527 in Advanced Hepatocellular Carcinoma in 128 participants. Completed in 23 February 2022.

Timeline

28 December 2016

Primary endpoint
23 February 2022

23 February 2022

Quick facts

Lead sponsor	H3 Biomedicine Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	128
Start date	28 December 2016
Primary completion	23 February 2022
Estimated completion	23 February 2022
Sites	44 locations across France, Italy, Russia, Belgium, Taiwan, United Kingdom, South Korea, Canada

Drugs / interventions tested

H3B-6527 — full drug profile →

Conditions studied

Advanced Hepatocellular Carcinoma — all drugs for Advanced Hepatocellular Carcinoma →
Hepatocellular Carcinoma — all drugs for Hepatocellular Carcinoma →
Liver Cancer — all drugs for Liver Cancer →
Liver Neoplasms — all drugs for Liver Neoplasms →

Sponsor

H3 Biomedicine Inc.

Who can join

18 and older, any sex, with Advanced Hepatocellular Carcinoma or Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Part 1, Dose Escalation Phase: Number of Participants With Dose-limiting Toxicities (DLTs) Based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 Primary · Cycle 1 (Cycle length = 21 days)

DLTs were defined as any of the following toxicities: Hematology, gastrointestinal, renal, hepatic or nonhematologic toxicities occurring during Cycle 1 in Dose Escalation Phase only and judged by the investigator as related to study drug. This included any Grade 4: neutropenia that does not resolve to Grade less than or equal to (\<=) 2 within 7 days, thrombocytopenia, anemia of any duration, diarrhea and/or vomiting irrespective of prophylaxis or appropriate treatment; Grade 3: thrombocytopenia requiring transfusion, thrombocytopenia and clinically significant bleeding, anemia if transfused

Group	Value	95% CI
Part 1, Dose Escalation Phase: H3B-6527 300 mg QD Fasted	0
Part 1, Dose Escalation Phase: H3B-6527 600 mg QD Fasted	0
Part 1, Dose Escalation Phase: H3B-6527 600 mg QD Fed	0
Part 1, Dose Escalation Phase: H3B-6527 1000 mg QD Fasted	0
Part 1, Dose Escalation Phase: H3B-6527 1000 mg QD Fed	0
Part 1, Dose Escalation Phase: H3B-6527 1400 mg QD Fasted	0
Part 1, Dose Escalation Phase: H3B-6527 1400 mg QD Fed	0
Part 1, Dose Escalation Phase: H3B-6527 2000 mg QD Fed	0
Part 1, Dose Escalation Phase: H3B-6527 500 mg BID Fasted	0
Part 1, Dose Escalation Phase: H3B-6527 500 mg BID Fed	0
Part 1, Dose Escalation Phase: H3B-6527 700 mg BID Fed	0

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Primary · From the first dose of study drug up to approximately 36.7 months

A TEAE was defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline) or reemerges during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE was continuous. An SAE was any untoward medical occurrence that at any dose: Resulted in death, was life-threatening (that is, the participant was at immediate risk of death from the AE as it occurred; this does not include an event that, had it occurred in a more severe form or was

Participants with TEAEs

Group	Value	95% CI
Part 1, Dose Escalation Phase: H3B-6527 300 mg QD Fasted	3
Part 1, Dose Escalation Phase: H3B-6527 600 mg QD Fasted	3
Part 1, Dose Escalation Phase: H3B-6527 600 mg QD Fed	4
Part 1, Dose Escalation Phase: H3B-6527 1000 mg QD Fasted	10
Part 1, Dose Escalation Phase: H3B-6527 1000 mg QD Fed	3
Part 1, Dose Escalation Phase: H3B-6527 1400 mg QD Fasted	7
Part 1, Dose Escalation Phase: H3B-6527 1400 mg QD Fed	4
Part 1, Dose Escalation Phase: H3B-6527 2000 mg QD Fed	7
Part 1, Dose Escalation Phase: H3B-6527 500 mg BID Fasted	3
Part 1, Dose Escalation Phase: H3B-6527 500 mg BID Fed	9
Part 1, Dose Escalation Phase: H3B-6527 700 mg BID Fed	5
Part 2, Dose Expansion Phase: H3B-6527 1000 mg QD	28

Participants with SAEs

Group	Value	95% CI
Part 1, Dose Escalation Phase: H3B-6527 300 mg QD Fasted	0
Part 1, Dose Escalation Phase: H3B-6527 600 mg QD Fasted	0
Part 1, Dose Escalation Phase: H3B-6527 600 mg QD Fed	1
Part 1, Dose Escalation Phase: H3B-6527 1000 mg QD Fasted	1
Part 1, Dose Escalation Phase: H3B-6527 1000 mg QD Fed	1
Part 1, Dose Escalation Phase: H3B-6527 1400 mg QD Fasted	4
Part 1, Dose Escalation Phase: H3B-6527 1400 mg QD Fed	1
Part 1, Dose Escalation Phase: H3B-6527 2000 mg QD Fed	2
Part 1, Dose Escalation Phase: H3B-6527 500 mg BID Fasted	2
Part 1, Dose Escalation Phase: H3B-6527 500 mg BID Fed	3
Part 1, Dose Escalation Phase: H3B-6527 700 mg BID Fed	1
Part 2, Dose Expansion Phase: H3B-6527 1000 mg QD	11

Area Under the Plasma Concentration-time Curve From Time 0 Through the Last Measurable Point (AUC0-t) of H3B-6527 Secondary · Part 1, Cycle 1 Day 1 and Day 8: 0-24 hours post-dose (for QD dosing) and 0-10 hours post-dose (for BID dosing); Part 2, Cycle 1 Day 8: 0-24 hours post-dose (for QD dosing) and 0-10 hours post-dose (for BID dosing) (Cycle 1 length = 21 days)

Cycle 1 Day 1

Group	Value	95% CI
Part 1, Dose Escalation Phase: H3B-6527 300 mg QD Fasted	68.9	± 57.5
Part 1, Dose Escalation Phase: H3B-6527 600 mg QD Fasted	173	± 1891.9
Part 1, Dose Escalation Phase: H3B-6527 600 mg QD Fed	1631	± 271.8
Parts 1 and 2, Dose Escalation + Expansion Phase: H3B-6527 1000 mg QD Fasted	850	± 531.5
Parts 1 and 2, Dose Escalation + Expansion Phase: H3B-6527 1000 mg QD Fed	1115	± 909.7
Part 1, Dose Escalation Phase: H3B-6527 1400 mg QD Fasted	400	± 187.5
Part 1, Dose Escalation Phase: H3B-6527 1400 mg QD Fed	5671	± 98.7
Part 1, Dose Escalation Phase: H3B-6527 2000 mg QD Fed	2748	± 66.3
Part 1, Dose Escalation Phase: H3B-6527 500 mg BID Fasted	462	± 137.0
Parts 1 and 2, Dose Escalation + Expansion Phase: H3B-6527 500 mg BID Fed	752	± 204.3
Part 1, Dose Escalation Phase: H3B-6527 700 mg BID Fed	576	± 482.6

Cycle 1 Day 8

Group	Value	95% CI
Part 1, Dose Escalation Phase: H3B-6527 300 mg QD Fasted	50.8	± 47.5
Part 1, Dose Escalation Phase: H3B-6527 600 mg QD Fasted	636	± 39.4
Part 1, Dose Escalation Phase: H3B-6527 600 mg QD Fed	484	± 3217.3
Parts 1 and 2, Dose Escalation + Expansion Phase: H3B-6527 1000 mg QD Fasted	784	± 431.8
Parts 1 and 2, Dose Escalation + Expansion Phase: H3B-6527 1000 mg QD Fed	798	± 337.8
Part 1, Dose Escalation Phase: H3B-6527 1400 mg QD Fasted	1244	± 827.7
Part 1, Dose Escalation Phase: H3B-6527 1400 mg QD Fed	5447	± 74.9
Part 1, Dose Escalation Phase: H3B-6527 2000 mg QD Fed	1838	± 179.3
Part 1, Dose Escalation Phase: H3B-6527 500 mg BID Fasted	1056	± 36.9
Parts 1 and 2, Dose Escalation + Expansion Phase: H3B-6527 500 mg BID Fed	809	± 237.3
Part 1, Dose Escalation Phase: H3B-6527 700 mg BID Fed	622	± 351.1

Maximum Observed Plasma Concentration (Cmax) of H3B-6527 Secondary · Part 1, Cycle 1 Day 1 and Day 8: 0-24 hours post-dose (for QD dosing) and 0-10 hours post-dose (for BID dosing); Part 2, Cycle 1 Day 8: 0-24 hours post-dose (for QD dosing) and 0-10 hours post-dose (for BID dosing) (Cycle 1 length = 21 days)

Cycle 1 Day 1

Group	Value	95% CI
Part 1, Dose Escalation Phase: H3B-6527 300 mg QD Fasted	20.3	± 64.1
Part 1, Dose Escalation Phase: H3B-6527 600 mg QD Fasted	74.5	± 1389.4
Part 1, Dose Escalation Phase: H3B-6527 600 mg QD Fed	395	± 133.7
Parts 1 and 2, Dose Escalation + Expansion Phase: H3B-6527 1000 mg QD Fasted	225	± 470.2
Parts 1 and 2, Dose Escalation + Expansion Phase: H3B-6527 1000 mg QD Fed	182	± 494.6
Part 1, Dose Escalation Phase: H3B-6527 1400 mg QD Fasted	136	± 429.4
Part 1, Dose Escalation Phase: H3B-6527 1400 mg QD Fed	904	± 34.2
Part 1, Dose Escalation Phase: H3B-6527 2000 mg QD Fed	540	± 79.9
Part 1, Dose Escalation Phase: H3B-6527 500 mg BID Fasted	124	± 159.1
Parts 1 and 2, Dose Escalation + Expansion Phase: H3B-6527 500 mg BID Fed	255	± 251.6
Part 1, Dose Escalation Phase: H3B-6527 700 mg BID Fed	163	± 303.2

Cycle 1 Day 8

Group	Value	95% CI
Part 1, Dose Escalation Phase: H3B-6527 300 mg QD Fasted	10.8	± 90.6
Part 1, Dose Escalation Phase: H3B-6527 600 mg QD Fasted	194	± 45.6
Part 1, Dose Escalation Phase: H3B-6527 600 mg QD Fed	99.6	± 5300.4
Parts 1 and 2, Dose Escalation + Expansion Phase: H3B-6527 1000 mg QD Fasted	187	± 339.1
Parts 1 and 2, Dose Escalation + Expansion Phase: H3B-6527 1000 mg QD Fed	177	± 370.3
Part 1, Dose Escalation Phase: H3B-6527 1400 mg QD Fasted	362	± 898.5
Part 1, Dose Escalation Phase: H3B-6527 1400 mg QD Fed	827	± 40.6
Part 1, Dose Escalation Phase: H3B-6527 2000 mg QD Fed	502	± 95.2
Part 1, Dose Escalation Phase: H3B-6527 500 mg BID Fasted	251	± 46.5
Parts 1 and 2, Dose Escalation + Expansion Phase: H3B-6527 500 mg BID Fed	211	± 237.2
Part 1, Dose Escalation Phase: H3B-6527 700 mg BID Fed	167	± 202.7

Time of Maximum Observed Plasma Concentration (Tmax) of H3B-6527 Secondary · Part 1, Cycle 1 Day 1 and Day 8: 0-24 hours post-dose (for QD dosing) and 0-10 hours post-dose (for BID dosing); Part 2, Cycle 1 Day 8: 0-24 hours post-dose (for QD dosing) and 0-10 hours post-dose (for BID dosing) (Cycle 1 length = 21 days)

Cycle 1 Day 1

Group	Value	95% CI
Part 1, Dose Escalation Phase: H3B-6527 300 mg QD Fasted	2.00	2.00 – 4.00
Part 1, Dose Escalation Phase: H3B-6527 600 mg QD Fasted	1.00	0.50 – 2.00
Part 1, Dose Escalation Phase: H3B-6527 600 mg QD Fed	4.00	1.00 – 4.07
Parts 1 and 2, Dose Escalation + Expansion Phase: H3B-6527 1000 mg QD Fasted	2.02	1.00 – 8.12
Parts 1 and 2, Dose Escalation + Expansion Phase: H3B-6527 1000 mg QD Fed	6.00	4.10 – 6.00
Part 1, Dose Escalation Phase: H3B-6527 1400 mg QD Fasted	1.00	0.63 – 4.15
Part 1, Dose Escalation Phase: H3B-6527 1400 mg QD Fed	5.00	2.00 – 8.00
Part 1, Dose Escalation Phase: H3B-6527 2000 mg QD Fed	2.100	1.00 – 4.92
Part 1, Dose Escalation Phase: H3B-6527 500 mg BID Fasted	2.12	2.00 – 4.57
Parts 1 and 2, Dose Escalation + Expansion Phase: H3B-6527 500 mg BID Fed	4.02	0.57 – 10.00
Part 1, Dose Escalation Phase: H3B-6527 700 mg BID Fed	2.02	0.50 – 6.12

Cycle 1 Day 8

Group	Value	95% CI
Part 1, Dose Escalation Phase: H3B-6527 300 mg QD Fasted	4.00	2.07 – 4.00
Part 1, Dose Escalation Phase: H3B-6527 600 mg QD Fasted	0.52	0.50 – 2.00
Part 1, Dose Escalation Phase: H3B-6527 600 mg QD Fed	4.52	0.53 – 6.00
Parts 1 and 2, Dose Escalation + Expansion Phase: H3B-6527 1000 mg QD Fasted	2.00	0.33 – 10.00
Parts 1 and 2, Dose Escalation + Expansion Phase: H3B-6527 1000 mg QD Fed	2.00	1.00 – 4.33
Part 1, Dose Escalation Phase: H3B-6527 1400 mg QD Fasted	2.10	1.00 – 4.13
Part 1, Dose Escalation Phase: H3B-6527 1400 mg QD Fed	5.86	2.00 – 6.22
Part 1, Dose Escalation Phase: H3B-6527 2000 mg QD Fed	4.00	1.00 – 8.42
Part 1, Dose Escalation Phase: H3B-6527 500 mg BID Fasted	4.00	2.10 – 4.17
Parts 1 and 2, Dose Escalation + Expansion Phase: H3B-6527 500 mg BID Fed	4.00	0.00 – 10.00
Part 1, Dose Escalation Phase: H3B-6527 700 mg BID Fed	4.12	0.50 – 10.00

Part 2, Dose Expansion Phase: Objective Response Rate (ORR) Based on Modified Response Evaluation Criteria in Solid Tumors (mRECIST) v1.1 Secondary · From the first dose date until disease progression/recurrence or up to approximately 36.7 months

ORR was defined as the percentage of participants achieving a best overall confirmed response of partial response (PR) or complete response (CR) (PR + CR), from the first dose date until disease progression/recurrence. Responses (PR or CR) were confirmed no less than 4 weeks after the initial response. CR was defined as the disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in the short axis to less than 10 millimeter (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking a

Group	Value	95% CI
Part 2, Dose Expansion Phase: H3B-6527 1000 mg QD	5.6	0.1 – 27.3
Part 2, Dose Expansion Phase: H3B-6527 500 mg BID Fed	0.0	0.0 – 10.9

Part 2, Dose Expansion Phase: Duration of Response (DOR) Based on Modified Response Evaluation Criteria in Solid Tumors (mRECIST) v1.1 Secondary · From the date of first documented CR or PR up to approximately 36.7 months

DOR was defined as the time from the date of first documented CR or PR based on modified RECIST v1.1 until the first documentation of disease progression (PD) as determined by the investigator or death, whichever comes first. CR was defined as the disappearance of all target lesions and non-target lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD was defined as at least a 20% increase in the sum of long diameter (LD) of target and non-target lesions as compared with the smallest sum of LD and the

Group	Value	95% CI
Part 2, Dose Expansion Phase: H3B-6527 1000 mg QD	NA	NA – NA

Part 2, Dose Expansion Phase: Progression-free Survival (PFS) Based on Modified Response Evaluation Criteria in Solid Tumors (mRECIST) v1.1 Secondary · From the first dose date to the date of the first documentation of PD as determined by the investigator or death (whichever occurs first) up to approximately 36.7 months

PFS was defined as the time from the first dose date to the date of the first documentation of PD as determined by the investigator or death (whichever occurs first). PD was defined as at least a 20% increase in the sum of LD of target and non-target lesions as compared with the smallest sum of LD and the increase of LD was at least 5 mm (including new lesions).

Group	Value	95% CI
Part 2, Dose Expansion Phase: H3B-6527 1000 mg QD	2.6	1.3 – 5.5
Part 2, Dose Expansion Phase: H3B-6527 500 mg BID Fed	3.0	1.5 – 4.1

Part 2, Dose Expansion Phase: Overall Survival (OS) Secondary · From the date of first dose of study drug until date of death from any cause (up to approximately 36.7 months)

OS was defined as the time from the first dose date to the date of death. OS was assessed using Kaplan-Meier method. The time of death was censored for participants who were without death information at the time of OS analysis.

Group	Value	95% CI
Part 2, Dose Expansion Phase: H3B-6527 1000 mg QD	9.5	2.3 – 24.4
Part 2, Dose Expansion Phase: H3B-6527 500 mg BID Fed	7.7	4.7 – 11.3

Part 2, Dose Expansion Phase: Time to Response (TTR) Based on Modified Response Evaluation Criteria in Solid Tumors (mRECIST) v1.1 Secondary · From date of first dose of study drug until CR or PR (up to approximately 36.7 months)

TTR was defined as the time from the first dose date to the date of first documented CR/PR. CR was defined as the disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in the short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.

Group	Value	95% CI
Part 2, Dose Expansion Phase: H3B-6527 1000 mg QD	NA	NA – NA

Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters Primary · From baseline up to approximately 36.7 months

Laboratory assessment included hematology, coagulation, clinical chemistry, and urinalysis parameters.

Hematology

Group	Value	95% CI
Part 1, Dose Escalation Phase: H3B-6527 300 mg QD Fasted	0
Part 1, Dose Escalation Phase: H3B-6527 600 mg QD Fasted	0
Part 1, Dose Escalation Phase: H3B-6527 600 mg QD Fed	0
Part 1, Dose Escalation Phase: H3B-6527 1000 mg QD Fasted	0
Part 1, Dose Escalation Phase: H3B-6527 1000 mg QD Fed	0
Part 1, Dose Escalation Phase: H3B-6527 1400 mg QD Fasted	0
Part 1, Dose Escalation Phase: H3B-6527 1400 mg QD Fed	0
Part 1, Dose Escalation Phase: H3B-6527 2000 mg QD Fed	0
Part 1, Dose Escalation Phase: H3B-6527 500 mg BID Fasted	0
Part 1, Dose Escalation Phase: H3B-6527 500 mg BID Fed	0
Part 1, Dose Escalation Phase: H3B-6527 700 mg BID Fed	0
Part 2, Dose Expansion Phase: H3B-6527 1000 mg QD	0

Clinical Chemistry

Group	Value	95% CI
Part 1, Dose Escalation Phase: H3B-6527 300 mg QD Fasted	0
Part 1, Dose Escalation Phase: H3B-6527 600 mg QD Fasted	0
Part 1, Dose Escalation Phase: H3B-6527 600 mg QD Fed	0
Part 1, Dose Escalation Phase: H3B-6527 1000 mg QD Fasted	0
Part 1, Dose Escalation Phase: H3B-6527 1000 mg QD Fed	0
Part 1, Dose Escalation Phase: H3B-6527 1400 mg QD Fasted	0
Part 1, Dose Escalation Phase: H3B-6527 1400 mg QD Fed	0
Part 1, Dose Escalation Phase: H3B-6527 2000 mg QD Fed	0
Part 1, Dose Escalation Phase: H3B-6527 500 mg BID Fasted	0
Part 1, Dose Escalation Phase: H3B-6527 500 mg BID Fed	0
Part 1, Dose Escalation Phase: H3B-6527 700 mg BID Fed	0
Part 2, Dose Expansion Phase: H3B-6527 1000 mg QD	0

Urinalysis

Group	Value	95% CI
Part 1, Dose Escalation Phase: H3B-6527 300 mg QD Fasted	0
Part 1, Dose Escalation Phase: H3B-6527 600 mg QD Fasted	0
Part 1, Dose Escalation Phase: H3B-6527 600 mg QD Fed	0
Part 1, Dose Escalation Phase: H3B-6527 1000 mg QD Fasted	0
Part 1, Dose Escalation Phase: H3B-6527 1000 mg QD Fed	0
Part 1, Dose Escalation Phase: H3B-6527 1400 mg QD Fasted	0
Part 1, Dose Escalation Phase: H3B-6527 1400 mg QD Fed	0
Part 1, Dose Escalation Phase: H3B-6527 2000 mg QD Fed	0
Part 1, Dose Escalation Phase: H3B-6527 500 mg BID Fasted	0
Part 1, Dose Escalation Phase: H3B-6527 500 mg BID Fed	0
Part 1, Dose Escalation Phase: H3B-6527 700 mg BID Fed	0
Part 2, Dose Expansion Phase: H3B-6527 1000 mg QD	0

Coagulation

Group	Value	95% CI
Part 1, Dose Escalation Phase: H3B-6527 300 mg QD Fasted	0
Part 1, Dose Escalation Phase: H3B-6527 600 mg QD Fasted	0
Part 1, Dose Escalation Phase: H3B-6527 600 mg QD Fed	0
Part 1, Dose Escalation Phase: H3B-6527 1000 mg QD Fasted	0
Part 1, Dose Escalation Phase: H3B-6527 1000 mg QD Fed	0
Part 1, Dose Escalation Phase: H3B-6527 1400 mg QD Fasted	0
Part 1, Dose Escalation Phase: H3B-6527 1400 mg QD Fed	0
Part 1, Dose Escalation Phase: H3B-6527 2000 mg QD Fed	0
Part 1, Dose Escalation Phase: H3B-6527 500 mg BID Fasted	0
Part 1, Dose Escalation Phase: H3B-6527 500 mg BID Fed	0
Part 1, Dose Escalation Phase: H3B-6527 700 mg BID Fed	0
Part 2, Dose Expansion Phase: H3B-6527 1000 mg QD	0

Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters Primary · From baseline up to approximately 36.7 months

Group	Value	95% CI
Part 1, Dose Escalation Phase: H3B-6527 300 mg QD Fasted	0
Part 1, Dose Escalation Phase: H3B-6527 600 mg QD Fasted	0
Part 1, Dose Escalation Phase: H3B-6527 600 mg QD Fed	0
Part 1, Dose Escalation Phase: H3B-6527 1000 mg QD Fasted	0
Part 1, Dose Escalation Phase: H3B-6527 1000 mg QD Fed	0
Part 1, Dose Escalation Phase: H3B-6527 1400 mg QD Fasted	0
Part 1, Dose Escalation Phase: H3B-6527 1400 mg QD Fed	0
Part 1, Dose Escalation Phase: H3B-6527 2000 mg QD Fed	0
Part 1, Dose Escalation Phase: H3B-6527 500 mg BID Fasted	0
Part 1, Dose Escalation Phase: H3B-6527 500 mg BID Fed	0
Part 1, Dose Escalation Phase: H3B-6527 700 mg BID Fed	0
Part 2, Dose Expansion Phase: H3B-6527 1000 mg QD	0

Adverse events — posted to ClinicalTrials.gov

Time frame: From the first dose of study drug up to approximately 36.7 months. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part 1, Dose Escalation Phase: H3B-6527 300 mg QD Fasted

Serious: 0/3 (0%)

Deaths: 1/3

Part 1, Dose Escalation Phase: H3B-6527 600 mg QD Fasted

Serious: 0/3 (0%)

Deaths: 3/3

Part 1, Dose Escalation Phase: H3B-6527 600 mg QD Fed

Serious: 1/4 (25%)

Deaths: 2/4

Part 1, Dose Escalation Phase: H3B-6527 1000 mg QD Fasted

Serious: 1/10 (10%)

Deaths: 6/10

Part 1, Dose Escalation Phase: H3B-6527 1000 mg QD Fed

Serious: 1/3 (33%)

Deaths: 2/3

Part 1, Dose Escalation Phase: H3B-6527 1400 mg QD Fasted

Serious: 4/7 (57%)

Deaths: 7/7

Part 1, Dose Escalation Phase: H3B-6527 1400 mg QD Fed

Serious: 1/4 (25%)

Deaths: 3/4

Part 1, Dose Escalation Phase: H3B-6527 2000 mg QD Fed

Serious: 2/7 (29%)

Deaths: 1/7

Part 1, Dose Escalation Phase: H3B-6527 500 mg BID Fasted

Serious: 2/3 (67%)

Deaths: 3/3

Part 1, Dose Escalation Phase: H3B-6527 500 mg BID Fed

Serious: 3/10 (30%)

Deaths: 6/10

Part 1, Dose Escalation Phase: H3B-6527 700 mg BID Fed

Serious: 1/5 (20%)

Deaths: 4/5

Part 2, Dose Expansion Phase: H3B-6527 1000 mg QD

Serious: 11/29 (38%)

Deaths: 19/29

Part 2, Dose Expansion Phase: H3B-6527 500 mg BID Fed

Serious: 17/40 (43%)

Deaths: 31/40

Serious adverse events (49 terms)

Reaction	System	Part 1, Dose Escalation Ph…	Part 1, Dose Escalation Ph…	Part 1, Dose Escalation Ph…	Part 1, Dose Escalation Ph…	Part 1, Dose Escalation Ph…	Part 1, Dose Escalation Ph…	Part 1, Dose Escalation Ph…	Part 1, Dose Escalation Ph…	Part 1, Dose Escalation Ph…	Part 1, Dose Escalation Ph…	Part 1, Dose Escalation Ph…	Part 2, Dose Expansion Pha…	Part 2, Dose Expansion Pha…
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—
Pathological fracture	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Cardio-respiratory arrest	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Gastrointestinal haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Oesophageal varices haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Hepatic haemorrhage	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Anaphylactic reaction	Immune system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal sepsis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—
Post procedural complication	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—
Electrocardiogram QT prolonged	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Hepatic encephalopathy	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Acute kidney injury	Renal and urinary disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Peripheral embolism	Vascular disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Neck pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Tumour rupture	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—	—	—	—

Other adverse events (153 terms — click to expand)

Reaction	System	Part 1, Dose Escalation Ph…	Part 1, Dose Escalation Ph…	Part 1, Dose Escalation Ph…	Part 1, Dose Escalation Ph…	Part 1, Dose Escalation Ph…	Part 1, Dose Escalation Ph…	Part 1, Dose Escalation Ph…	Part 1, Dose Escalation Ph…	Part 1, Dose Escalation Ph…	Part 1, Dose Escalation Ph…	Part 1, Dose Escalation Ph…	Part 2, Dose Expansion Pha…	Part 2, Dose Expansion Pha…
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Blood bilirubin increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Hepatocellular injury	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Platelet count decreased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypoalbuminaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Lymphopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Blood alkaline phosphatase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—
Transaminases increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—
Weight decreased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypercalcaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Procedural pain	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Leukopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—
Gamma-glutamyltransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Hyperkalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Tumour haemorrhage, Diarrhoea, Asthenia, Malignant neoplasm progression, Pneumonia, Pathological fracture, Cardio-respiratory arrest, Abdominal pain.

Data from ClinicalTrials.gov NCT02834780 adverse events section.

Sponsor's own description

The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of H3B-6527, and to assess the safety, tolerability and pharmacokinetics of H3B-6527.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Molecular therapies and precision medicine for hepatocellular carcinoma.
Llovet JM, Montal R, Sia D, Finn RS. · · 2018 · cited 1481× · PMID 30061739 · DOI 10.1038/s41571-018-0073-4
Fibroblast Growth Factor Receptors (FGFRs): Structures and Small Molecule Inhibitors.
Dai S, Zhou Z, Chen Z, Xu G, et al · · 2019 · cited 216× · PMID 31216761 · DOI 10.3390/cells8060614
Cancer-associated fibroblasts and resistance to anticancer therapies: status, mechanisms, and countermeasures.
Feng B, Wu J, Shen B, Jiang F, et al · · 2022 · cited 150× · PMID 35488263 · DOI 10.1186/s12935-022-02599-7
Recent advances in systemic therapy for hepatocellular carcinoma.
Zhang H, Zhang W, Jiang L, Chen Y. · · 2022 · cited 150× · PMID 35000616 · DOI 10.1186/s40364-021-00350-4
Advances in drug development for hepatocellular carcinoma: clinical trials and potential therapeutic targets.
Luo XY, Wu KM, He XX. · · 2021 · cited 144× · PMID 34006331 · DOI 10.1186/s13046-021-01968-w
Small molecule inhibitors targeting the cancers.
Liu GH, Chen T, Zhang X, Ma XL, et al · · 2022 · cited 127× · PMID 36254250 · DOI 10.1002/mco2.181
FGF19-<i>FGFR4</i> Signaling in Hepatocellular Carcinoma.
Raja A, Park I, Haq F, Ahn SM. · · 2019 · cited 111× · PMID 31167419 · DOI 10.3390/cells8060536
FGFR-TKI resistance in cancer: current status and perspectives.
Yue S, Li Y, Chen X, Wang J, et al · · 2021 · cited 98× · PMID 33568192 · DOI 10.1186/s13045-021-01040-2

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02834780 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by H3 Biomedicine Inc.
Last refreshed: 13 November 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02834780.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02834780

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (49 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of H3B-6527

Other recruiting trials for Advanced Hepatocellular Carcinoma

Verify against primary sources