NCT04068519 is a Phase 1, PHASE2 clinical trial of Tislelizumab in Advanced Solid Tumors, sponsored by BeiGene.

Who is sponsoring NCT04068519?

NCT04068519 is sponsored by BeiGene.

What drugs are being tested in NCT04068519?

Interventions in NCT04068519: Tislelizumab.

What condition does NCT04068519 study?

NCT04068519 studies Advanced Solid Tumors.

Is NCT04068519 still recruiting?

NCT04068519 is currently completed. Last updated 26 October 2024.

Are results published for NCT04068519?

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

Last reviewed 2024-10-26 · How we verify

NCT04068519

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

Study Investigating Safety, Tolerability, Pharmacokinetics (PK) and Antitumor Activities of Anti-PD-1 (Programmed Death-1) Monoclonal Antibody

Completed Phase 1, PHASE2 Results posted Last updated 26 October 2024

What this trial tests

Phase 1, PHASE2 trial testing Tislelizumab in Advanced Solid Tumors in 300 participants. Completed in 31 May 2020.

Timeline

28 December 2016

Primary endpoint
1 December 2018

31 May 2020

Quick facts

Lead sponsor	BeiGene
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	300
Start date	28 December 2016
Primary completion	1 December 2018
Estimated completion	31 May 2020
Sites	12 locations across China

Drugs / interventions tested

Tislelizumab (TISLELIZUMAB) — full drug profile →

Conditions studied

Advanced Solid Tumors — all drugs for Advanced Solid Tumors →

Sponsor

BeiGene — full company profile →

Who can join

18 and older, any sex, with Advanced Solid Tumors. 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.

Dose Verification and PK Sub-study: Number Participants With Adverse Events Primary · Up to approximately 23 months

Number of participants with adverse events (AEs) and serious adverse events (SAEs), as defined per NCI-CTCAE Version 4.03, including physical examination, electrocardiograms and laboratory assessments

At least one treatment-emergent adverse event (TEAE)

Group	Value	95% CI
Dose Verification	20
PK Sub-study	54

TEAE Grade 3 of higher

Group	Value	95% CI
Dose Verification	9
PK Sub-study	21

Serious adverse event

Group	Value	95% CI
Dose Verification	4
PK Sub-study	14

Dose Verification: Recommended Dose of Tislelizumab Primary · Up to approximately 23 months

Recommended dose of tislelizumab for indication cohorts based on safety and tolerability

Group	Value	95% CI
Dose Verification	200

PK Sub-study: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Tislelizumab From Two Manufacturing Processes and Scales Primary · Predose, end of infusion, 3 hours, 6 hours on Day 1, Day 2, Day 4, Day 8, Day 15, Day 22, and Day 29 predose

Pharmacokinetics from products derived from two manufacturing scales at 500 liter and 2000 liter final manufacturing process (FMP) were evaluated

500L-FMP

Group	Value	95% CI
PK Sub-study	1113.9	997.6 – 1244

2000L-FMP

Group	Value	95% CI
PK Sub-study	1108	985.2 – 1246

PK Sub-study: Area Under the Concentration-time Curve From Time 0 to 28 Days Postdose (AUC0-28d) of Tislelizumab From Two Manufacturing Processes and Scales Primary · Predose, end of infusion, 3 hours, 6 hours on Day 1, Day 2, Day 4, Day 8, Day 15, Day 22, and Day 29 predose

Pharmacokinetics from products derived from two manufacturing scales at 500 liter and 2000 liter final manufacturing process (FMP) were evaluated

500L-FMP

Group	Value	95% CI
PK Sub-study	810.2	746.0 – 879.9

2000L-FMP

Group	Value	95% CI
PK Sub-study	801.7	740.8 – 867.5

PK Sub-study: Maximum Observed Concentration (Cmax) of Tislelizumab From Two Manufacturing Processes and Scales Primary · Predose, end of infusion, 3 hours, 6 hours on Day 1, Day 2, Day 4, Day 8, Day 15, Day 22, and Day 29 predose

Pharmacokinetics from products derived from two manufacturing scales at 500 liter and 2000 liter FMP were evaluated

500L-FMP

Group	Value	95% CI
PK Sub-study	77.3	73.6 – 81.2

2000L-FMP

Group	Value	95% CI
PK Sub-study	75.7	70.7 – 81.0

Indication Expansion: Objective Response Rate Primary · Up to approximately 3 years and 5 months

Objective response rate (ORR) is defined as the percentage of participants who achieved objective tumor response (complete response or partial response) according to RECIST Version 1.1. Indication expansion includes participants from all parts in the following indications: non-small cell lung cancer (NSCLC), melanoma, esophageal squamous cell carcinoma (ESCC), gastric cancer (GC), urothelial carcinoma (UC), nasopharyngeal carcinoma (NPC), renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors, and other tum

NSCLC

Group	Value	95% CI
Tislelizumab	17.9	8.9 – 30.4

Melanoma

Group	Value	95% CI
Tislelizumab	17.6	6.8 – 34.5

ESCC

Group	Value	95% CI
Tislelizumab	7.7	0.9 – 25.1

Group	Value	95% CI
Tislelizumab	16.7	4.7 – 37.4

Group	Value	95% CI
Tislelizumab	18.2	5.2 – 40.3

NPC

Group	Value	95% CI
Tislelizumab	47.6	25.7 – 70.2

RCC

Group	Value	95% CI
Tislelizumab	9.5	1.2 – 30.4

HCC

Group	Value	95% CI
Tislelizumab	16.7	3.6 – 41.4

Dose Verification: Area Under the Concentration-time Curve From Time 0 to 21 Days Postdose (AUC0-tau) of Tislelizumab Secondary · Predose, end of infusion, 1.5 hours, 6 hours on Day 1, Day 2, Day 4, Day 8, Day 15, Day 22 predose in Cycle 1 and Cycle 5 (21 days per cycle)

Cycle 1

Group	Value	95% CI
Dose Verification	600.1	± 144.5

Cycle 5

Group	Value	95% CI
Dose Verification	1122	± 352

Dose Verification: Maximum Observed Concentration (Cmax) of Tislelizumab Secondary · Predose, end of infusion, 1.5 hours, 6 hours on Day 1, Day 2, Day 4, Day 8, Day 15, Day 22 predose in Cycle 1 and Cycle 5 (21 days per cycle)

Cycle 1

Group	Value	95% CI
Dose Verification	67.8	± 12.8

Cycle 5

Group	Value	95% CI
Dose Verification	131	± 37.7

Dose Verification: Predose Plasma Concentration of Tislelizumab During Multiple Dosing (Ctrough) Secondary · Predose, end of infusion, 1.5 hours, 6 hours on Day 1, Day 2, Day 4, Day 8, Day 15, Day 22 predose in Cycle 1 and Cycle 5 (21 days per cycle)

Cycle 1

Group	Value	95% CI
Dose Verification	15.8	± 4.73

Cycle 5

Group	Value	95% CI
Dose Verification	31.4	± 9.55

Dose Verification: Apparent Terminal Half-life of Tislelizumab (t1/2) Secondary · Predose, end of infusion, 1.5 hours, 6 hours on Day 1, Day 2, Day 4, Day 8, Day 15, Day 22 predose in Cycle 1 and Cycle 5 (21 days per cycle)

Cycle 1

Group	Value	95% CI
Dose Verification	13.3	± 2.95

Cycle 5

Group	Value	95% CI
Dose Verification	16.9	± 3.79

Dose Verification: Clearance (Cl) Secondary · Predose, end of infusion, 1.5 hours, 6 hours on Day 1, Day 2, Day 4, Day 8, Day 15, Day 22 predose in Cycle 1 (21 days per cycle)

Group	Value	95% CI
Dose Verification	0.247	± 0.0918

Indication Expansion: Progression-free Survival (PFS) Secondary · Up to approximately 3 years and 5 months

Progression-free survival is defined as the time from the date of first study dose to disease progression or death, whichever comes first, as determined by Investigator per RECIST version 1.1. Indication expansion includes participants from all parts in the following indications: non-small cell lung cancer (NSCLC), melanoma, esophageal squamous cell carcinoma (ESCC), gastric cancer (GC), urothelial carcinoma (UC), nasopharyngeal carcinoma (NPC), renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors, and ot

NSCLC

Group	Value	95% CI
Tislelizumab	4.0	2.1 – 8.1

Melanoma

Group	Value	95% CI
Tislelizumab	2.2	2.0 – 6.1

ESCC

Group	Value	95% CI
Tislelizumab	2.1	2.0 – 4.2

Group	Value	95% CI
Tislelizumab	2.1	1.9 – 4.0

Group	Value	95% CI
Tislelizumab	2.1	2.0 – 4.3

NPC

Group	Value	95% CI
Tislelizumab	8.2	4.2 – 11.4

RCC

Group	Value	95% CI
Tislelizumab	4.1	2.1 – 10.4

HCC

Group	Value	95% CI
Tislelizumab	4.0	2.1 – 12.4

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 30 days after the last dose of study treatment; Up to approximately 3 years and 5 months. Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Tislelizumab

Serious: 85/300 (28%)

Deaths: 202/300

Serious adverse events (71 terms)

Reaction	System	Tislelizumab
Pneumonia	Infections and infestations	—
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	—
Death	General disorders	—
Intestinal obstruction	Gastrointestinal disorders	—
Pyrexia	General disorders	—
Hyperuricaemia	Metabolism and nutrition disorders	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—
Immune-mediated myocarditis	Cardiac disorders	—
Dysphagia	Gastrointestinal disorders	—
Vomiting	Gastrointestinal disorders	—
Aspartate aminotransferase increased	Investigations	—
Decreased appetite	Metabolism and nutrition disorders	—
Hypercalcaemia	Metabolism and nutrition disorders	—
Hyperglycaemia	Metabolism and nutrition disorders	—
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	—
Pneumonitis	Respiratory, thoracic and mediastinal disorders	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—
Anaemia	Blood and lymphatic system disorders	—
Atrial fibrillation	Cardiac disorders	—
Cardiopulmonary failure	Cardiac disorders	—
Cataract	Eye disorders	—
Retinal detachment	Eye disorders	—
Abdominal pain	Gastrointestinal disorders	—

Other adverse events (63 terms — click to expand)

Reaction	System	Tislelizumab
Anaemia	Blood and lymphatic system disorders	—
Aspartate aminotransferase increased	Investigations	—
Alanine aminotransferase increased	Investigations	—
Blood bilirubin increased	Investigations	—
Proteinuria	Renal and urinary disorders	—
Weight decreased	Investigations	—
Gamma-glutamyltransferase increased	Investigations	—
Hypothyroidism	Endocrine disorders	—
Pyrexia	General disorders	—
Bilirubin conjugated increased	Investigations	—
White blood cell count decreased	Investigations	—
Cough	Respiratory, thoracic and mediastinal disorders	—
Hypoalbuminaemia	Metabolism and nutrition disorders	—
Weight increased	Investigations	—
Constipation	Gastrointestinal disorders	—
Decreased appetite	Metabolism and nutrition disorders	—
Malaise	General disorders	—
Upper respiratory tract infection	Infections and infestations	—
Platelet count decreased	Investigations	—
Rash	Skin and subcutaneous tissue disorders	—
Blood alkaline phosphatase increased	Investigations	—
Blood lactate dehydrogenase increased	Investigations	—
Neutrophil count decreased	Investigations	—
Hyperuricaemia	Metabolism and nutrition disorders	—
Pruritus	Skin and subcutaneous tissue disorders	—
Diarrhoea	Gastrointestinal disorders	—
Blood bilirubin unconjugated increased	Investigations	—
Hypokalaemia	Metabolism and nutrition disorders	—
Hyponatraemia	Metabolism and nutrition disorders	—
Fatigue	General disorders	—
Back pain	Musculoskeletal and connective tissue disorders	—
Nausea	Gastrointestinal disorders	—
Vomiting	Gastrointestinal disorders	—
White blood cells urine positive	Investigations	—
Insomnia	Psychiatric disorders	—
Protein urine present	Investigations	—
Red blood cells urine positive	Investigations	—
Hyperglycaemia	Metabolism and nutrition disorders	—
Blood creatine phosphokinase increased	Investigations	—
Blood creatinine increased	Investigations	—

Most-reported serious reactions: Pneumonia, Upper gastrointestinal haemorrhage, Death, Intestinal obstruction, Pyrexia, Hyperuricaemia, Dyspnoea, Immune-mediated myocarditis.

Data from ClinicalTrials.gov NCT04068519 adverse events section.

Sponsor's own description

This was a dose verification, pharmacokinetic (PK) assessment of products derived from two manufacturing processes and scales (500L-FMP and 2000L-FMP; FMP: Final Manufacturing Process) and indication expansion clinical study of monoclonal antibody conducted in Chinese subjects with advanced solid tumors, with a purpose of exploring the safety, tolerability, pharmacokinetics and preliminary efficacy.

Publications & conference data

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

Tislelizumab Plus Chemotherapy vs Chemotherapy Alone as First-line Treatment for Advanced Squamous Non-Small-Cell Lung Cancer: A Phase 3 Randomized Clinical Trial.
Wang J, Lu S, Yu X, Hu Y, et al · · 2021 · cited 312× · PMID 33792623 · DOI 10.1001/jamaoncol.2021.0366
Tislelizumab in Asian patients with previously treated locally advanced or metastatic urothelial carcinoma.
Ye D, Liu J, Zhou A, Zou Q, et al · · 2021 · cited 85× · PMID 33047430 · DOI 10.1111/cas.14681
Current Landscape and Future Directions of Biomarkers for Immunotherapy in Hepatocellular Carcinoma.
Gok Yavuz B, Hasanov E, Lee SS, Mohamed YI, et al · · 2021 · cited 32× · PMID 34595140 · DOI 10.2147/jhc.s322289
Could We Predict the Response of Immune Checkpoint Inhibitor Treatment in Hepatocellular Carcinoma?
Lee CK, Chan SL, Chon HJ. · · 2022 · cited 15× · PMID 35804984 · DOI 10.3390/cancers14133213
Model-based population pharmacokinetic analysis of tislelizumab in patients with advanced tumors.
Budha N, Wu CY, Tang Z, Yu T, et al · · 2023 · cited 12× · PMID 36330700 · DOI 10.1002/psp4.12880
The combination of gene hyperamplification and PD-L1 expression as a biomarker for the clinical benefit of tislelizumab in gastric/gastroesophageal junction adenocarcinoma.
Lu Z, Yang S, Luo X, Shi Y, et al · · 2022 · cited 10× · PMID 35778636 · DOI 10.1007/s10120-022-01308-7
Co-enrichment of CD8-positive T cells and macrophages is associated with clinical benefit of tislelizumab in solid tumors.
Ye D, Desai J, Shi J, Liu SM, et al · · 2023 · cited 9× · PMID 36879284 · DOI 10.1186/s40364-023-00465-w
Clinical dose rationale of tislelizumab in patients with solid or hematological advanced tumors.
Yu T, Liu X, Wu CY, Tang Z, et al · · 2024 · cited 5× · PMID 38515348 · DOI 10.1111/cts.13769

Verify or expand the search:

Other trials of Tislelizumab

Trials testing the same drug.

NCT07469306 — Short-Course RT Plus CAPOX and Tislelizumab vs Long-Course CRT Plus Tislelizumab for Locally Advanced Rectal Cancer · Phase 2 · not yet recruiting
NCT07475026 — A Study of Neoadjuvant Tislelizumab Plus Lenvatinib in Resectable HCC at High Risk of Recurrence · Phase 3 · not yet recruiting
NCT07528274 — Microwave Ablation Plus Tislelizumab and Docetaxel in Advanced NSCLC After First-Line Immunotherapy Failure · Phase 2 · recruiting
NCT07290985 — AACR Adaptive Biomarker-Driven Organ Preservation Trial in Gastroesophageal Adenocarcinomas · Phase 2 · not yet recruiting
NCT07518706 — Neoadjuvant Tislelizumab-Lenvatinib vs Surgery Alone in Stage Ia HCC With Narrow Margin · Phase 2 · not yet recruiting

Other recruiting trials for Advanced Solid Tumors

Currently open trials in the same condition.

NCT07504445 — Clinical Study on the Efficacy and Safety of CAR-DC in the Treatment of Advanced Solid Tumors · EARLY_PHASE1 · recruiting
NCT07589530 — Phase 1/2 Study of EB-NK-301 (Allogeneic TROP2-CAR NK Cells) in Advanced TROP2-Expressing Solid Tumors · Phase 1, PHASE2 · recruiting
NCT07360314 — Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors · Phase 1 · recruiting
NCT07414316 — A Single-Arm, Open-Label Clinical Study GK01 Cell Injection in Subjects With Advanced Solid Tumors. · EARLY_PHASE1 · recruiting
NCT07222969 — A Clinical Study to Evaluate the Safety of VIB305 in Patients With Advanced Solid Tumors · Phase 1, PHASE2 · recruiting

Other BeiGene trials

Trials by the same sponsor.

NCT07169331 — A Study to Evaluate the Efficacy and Safety of Zanubrutinib in Chinese Adults With Treatment-Naive Waldenström Macroglob · Phase 4 · recruiting
NCT07100938 — A Study Investigating the Efficacy and Safety of BGB-45035 Versus Placebo in Adults With Moderate to Severe Active Rheum · Phase 2 · active not recruiting
NCT07005713 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple-Ascending Doses of BGB- · Phase 1 · active not recruiting
NCT06906809 — Effect of Phenytoin or Itraconazole on How BGB-16673 is Absorbed and Removed From the Body in Healthy Participants · Phase 1 · completed
NCT06803680 — A Study of BGB-B455 in Adults With Advanced or Metastatic Solid Tumors · Phase 1 · recruiting

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 NCT04068519 (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 BeiGene
Last refreshed: 26 October 2024

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/NCT04068519.

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

NCT04068519

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 (71 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Tislelizumab

Other recruiting trials for Advanced Solid Tumors

Other BeiGene trials

Verify against primary sources