Study on Safety and Efficacy of NMS-01940153E in Adult Patients With Unresectable Hepatocellular Carcinoma (HCC) Previously Treated With Systemic Therapy
TerminatedPhase 1, PHASE2Results postedLast updated 19 June 2025
What this trial tests
Phase 1, PHASE2 trial testing NMS-01940153E in Unresectable Hepatocellular Carcinoma (HCC) in 31 participants. Terminated before completion.
18 and older, any sex, with Unresectable Hepatocellular Carcinoma (HCC). 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.
Phase I Drug Related Dose Limiting Toxicities (DLTs)Primary· Phase I: From screening to end of first 28-day cycle (17 months)
All 12 Phase I treated patients were evaluable for DLT (Dose-Limiting Toxicity Evaluable Set) and included 6 patients treated at each of the two dose levels explored (i.e., 100 mg/m2/week and 135 mg/m2/week) who received at least 66% of the study drug in the first 28-day cycle of treatment and underwent a DLT assessment within the DLT window.
Participants who experienced DLTs are presented.
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I)
0
135 mg/m2/Week Dose (Phase I)
2
Phase II Objective Response RatePrimary· Phase II: From Phase II start to Study Completion (23 months)
The objective response rate (ORR) was calculated as the proportion of evaluable patients who achieved, as best overall response (BOR), confirmed complete response (CR) or partial response (PR) measured by investigator-assessed RECIST 1.1 (Phase II).
Stable Disease
Group
Value
95% CI
Phase II (Evaluable Population)
3
Progressive Disease
Group
Value
95% CI
Phase II (Evaluable Population)
11
Complete Response
Group
Value
95% CI
Phase II (Evaluable Population)
0
Partial Response
Group
Value
95% CI
Phase II (Evaluable Population)
0
Treatment-emergent Adverse Events by Maximum CTC GradeSecondary· Phase I: From the Study Start Date to Phase I Completion (32 months) - Phase II: From Phase II start to Study Completion (23 months)
The maximum Common Terminology Criteria (CTC) grade (graded using National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] Version 5.0) experienced by each participant is presented. If an AE was reported for a participant more than once during treatment, the worst CTC Grade is presented here. Phase 2 started before Phase 1 completed.
Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental acti
Grade 1
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I)
0
135 mg/m2/Week Dose (Phase I)
0
Phase II (Evaluable Population)
3
Grade 2
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I)
1
135 mg/m2/Week Dose (Phase I)
1
Phase II (Evaluable Population)
8
Grade 3
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I)
3
135 mg/m2/Week Dose (Phase I)
3
Phase II (Evaluable Population)
7
Grade 4
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I)
1
135 mg/m2/Week Dose (Phase I)
2
Phase II (Evaluable Population)
0
Treatment-emergent Adverse Events Related to NMS-01940153ESecondary· Phase I: From the Study Start Date to Phase I Completion (32 months) - Phase II: From Phase II start to Study Completion (23 months)
The number of treatment-emergent adverse events related to NMS-01940153E by maximum CTC grade experienced (graded using NCI CTCAE Version 5.0). Whether the the AE was related or not was assessed by the investigator. If an AE was reported for a participant more than once during treatment, the worst CTC Grade is presented.
Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.
Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living.
Grade 3 Severe or med
Grade 1
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I)
0
135 mg/m2/Week Dose (Phase I)
0
Phase II (Evaluable Population)
7
Grade 2
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I)
1
135 mg/m2/Week Dose (Phase I)
1
Phase II (Evaluable Population)
3
Grade 3
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I)
2
135 mg/m2/Week Dose (Phase I)
2
Phase II (Evaluable Population)
2
Grade 4
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I)
1
135 mg/m2/Week Dose (Phase I)
2
Phase II (Evaluable Population)
0
Hematology: Overall Treatment-emergent Abnormalities by Dose Level and Maximum CTC GradeSecondary· From screening to 28 days follow-up, an average 6 months
Number of treatment emergent abnormalities (at any grade) at all dose levels are presented.
CTC = Common Terminology Criteria WBC = white blood cells
Hemoglobin Decreased
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I and II)
13
135 mg/m2/Week Dose (Phase I Only)
5
All Treated Participants (Phase I and II; All Dose Levels)
18
Neutrophil Count Decreased
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I and II)
6
135 mg/m2/Week Dose (Phase I Only)
4
All Treated Participants (Phase I and II; All Dose Levels)
10
WBC Decreased
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I and II)
8
135 mg/m2/Week Dose (Phase I Only)
6
All Treated Participants (Phase I and II; All Dose Levels)
14
Platelet Count Decreased
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I and II)
6
135 mg/m2/Week Dose (Phase I Only)
4
All Treated Participants (Phase I and II; All Dose Levels)
10
Neutrophils Count Decrease: Time to First Occurrence of >=Grade 3 and Time to Recovery to Grade 1Secondary· From screening to 28 days follow-up, an average 6 months
The mean days to first occurrence of neutrophil count decrease are presented for all dose levels.
Grade 0: ≥2,000/mm3 Grade 1: ≥1,500-\< 2,000/mm3 Grade 2: ≥1,000- \< 1,500/mm3 Grade 3: ≥500- \< 1,000/mm3 Grade 4: \<500/mm3
* G3 = Time (days) to Treatment Start to First Occurrence of Neutrophil Count Decrease \>=Grade 3
* G3 to Recovery to G1 = Time (days) to First Occurrence of Neutrophil Count Decrease \>= Grade 3 to Recovery to Grade 1
>=G3
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I and II)
63.00
± 19.80
135 mg/m2/Week Dose (Phase I Only)
28.00
± 15.36
All Treated Participants (Phase I and II; All Dose Levels)
39.67
± 23.38
>= G3 to Recovery to G1
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I and II)
7.00
± 1.41
135 mg/m2/Week Dose (Phase I Only)
7.33
± 3.51
All Treated Participants (Phase I and II; All Dose Levels)
7.20
± 2.59
Blood Chemistry: Treatment-emergent Abnormalities by Dose LevelSecondary· From screening to 28 days follow-up, an average 6 months
Treatment-emergent abnormalities in blood chemistry at any grade are presented by dose level.
ALP = Alkaline phosphatase ALT = Alanine aminotransferase AST = Aspartate aminotransferase GGT = Gamma-glutamyl transferase LDH = Lactate dehydrogenase
Hypoalbuminemia
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I and II)
8
135 mg/m2/Week Dose (Phase I Only)
4
All Treated Participants (Phase I and II; All Dose Levels)
12
Hypoglycemia
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I and II)
0
135 mg/m2/Week Dose (Phase I Only)
1
All Treated Participants (Phase I and II; All Dose Levels)
1
AST Increased
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I and II)
12
135 mg/m2/Week Dose (Phase I Only)
3
All Treated Participants (Phase I and II; All Dose Levels)
15
ALT Increased
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I and II)
8
135 mg/m2/Week Dose (Phase I Only)
2
All Treated Participants (Phase I and II; All Dose Levels)
10
GGT Increased
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I and II)
9
135 mg/m2/Week Dose (Phase I Only)
1
All Treated Participants (Phase I and II; All Dose Levels)
10
Creatinine Increased
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I and II)
6
135 mg/m2/Week Dose (Phase I Only)
3
All Treated Participants (Phase I and II; All Dose Levels)
9
Blood Bilirubin Increased
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I and II)
7
135 mg/m2/Week Dose (Phase I Only)
1
All Treated Participants (Phase I and II; All Dose Levels)
8
ALP Increased
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I and II)
10
135 mg/m2/Week Dose (Phase I Only)
1
All Treated Participants (Phase I and II; All Dose Levels)
11
Blood Chemistry and Coagulation: Treatment-emergent AbnormalitiesSecondary· From screening to 28 days follow-up, an average 6 months
Treatment Emergent abnormalities by dose Level are presented for blood chemistry and coagulation parameters.
INR = international normalized ratio LNL = lower normal limit NL = normal limit ULN = upper limit of normal
Hyponatremia: Total
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I and II)
4
135 mg/m2/Week Dose (Phase I Only)
2
All Treated Participants (Phase I and II; All Dose Levels)
6
Hyponatremia: Below LNL
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I and II)
4
135 mg/m2/Week Dose (Phase I Only)
2
All Treated Participants (Phase I and II; All Dose Levels)
6
Hypokalemia: Total
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I and II)
0
135 mg/m2/Week Dose (Phase I Only)
1
All Treated Participants (Phase I and II; All Dose Levels)
1
Hypokalemia: Below LNL
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I and II)
0
135 mg/m2/Week Dose (Phase I Only)
1
All Treated Participants (Phase I and II; All Dose Levels)
1
Phosphatemia: Total
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I and II)
11
135 mg/m2/Week Dose (Phase I Only)
2
All Treated Participants (Phase I and II; All Dose Levels)
13
Phosphatemia: Above ULN
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I and II)
3
135 mg/m2/Week Dose (Phase I Only)
0
All Treated Participants (Phase I and II; All Dose Levels)
3
Phosphatemia: Below LNL
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I and II)
7
135 mg/m2/Week Dose (Phase I Only)
2
All Treated Participants (Phase I and II; All Dose Levels)
9
Phosphatemia: Above/Below NL
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I and II)
1
135 mg/m2/Week Dose (Phase I Only)
0
All Treated Participants (Phase I and II; All Dose Levels)
1
Electrocardiogram AbnormalitiesSecondary· From screening to 28 days follow-up, an average 6 months
The number of participants who experienced electrocardiogram abnormalities are presented.
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I)
0
135 mg/m2/Week Dose (Phase I)
0
Phase II (Evaluable Population)
0
Tmax and Tlast of NMS-01940153ESecondary· Day 1 to Day 15
Plasma pharmacokinetic (PK) profiles of NMS-01940153E were characterized on Day 1 and 15 of the first Cycle after infusion.
Tmax = Time to maximum observed plasma concentration Tlast = Time of last detectable concentration
Tmax: Day 1
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I Only)
0.933
± 0.0327
135 mg/m2/Week Dose (Phase I Only)
1.19
± 0.513
Tmax: Day 15
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I Only)
1.10
± 0.216
135 mg/m2/Week Dose (Phase I Only)
1.87
± 1.90
Tlast: Day 1
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I Only)
169
± 3.01
135 mg/m2/Week Dose (Phase I Only)
154
± 39.2
Tlast: Day 15
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I Only)
144
± 48.5
135 mg/m2/Week Dose (Phase I Only)
169
± 0.418
Cmax and Clast of NMS-01940153ESecondary· Day 1 to Day 15
Plasma pharmacokinetic (PK) profiles of NMS-01940153E were characterized on Day 1 and 15 of the first Cycle after infusion.
Cmax = Maximum observed plasma concentration Clast = Last detectable concentration
Cmax: Day 1
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I Only)
0.754
± 0.174
135 mg/m2/Week Dose (Phase I Only)
1.91
± 0.640
Cmax: Day 15
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I Only)
1.35
± 1.10
135 mg/m2/Week Dose (Phase I Only)
1.59
± 1.31
Clast: Day 1
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I Only)
0.0590
± 0.0191
135 mg/m2/Week Dose (Phase I Only)
0.0840
± 0.0335
Clast: Day 15
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I Only)
0.113
± 0.0454
135 mg/m2/Week Dose (Phase I Only)
0.133
± 0.0779
AUClast, AUCweekly, and AUCinf of NMS-01940153ESecondary· From Days 1 to 21 (168 hours after the Day 15 infusion)
Plasma pharmacokinetic (PK) profiles of NMS-01940153E were characterized on Day 1 and 15 of the first Cycle after infusion. Infusions occurred on Days 1, 8, and 15.
AUClast = Area under the interpolated observed plasma time-concentration curve from infusion start to the last observed plasma concentration AUCweekly = Area under the interpolated observed plasma time-concentration curve from infusion start to 168 hours AUCinf = Area under the interpolated observed plasma time-concentration curve from infusion start extrapolated to infinity based on the last observed plasma concentration
AUClast: Day 1
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I Only)
20.8
± 4.31
135 mg/m2/Week Dose (Phase I Only)
24.8
± 8.55
AUClast: Day 15
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I Only)
30.0
± 9.16
135 mg/m2/Week Dose (Phase I Only)
39.1
± 14.9
AUCweekly: Day 1
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I Only)
20.8
± 4.35
135 mg/m2/Week Dose (Phase I Only)
25.7
± 7.11
AUCweekly: Day 15
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I Only)
32.4
± 6.49
135 mg/m2/Week Dose (Phase I Only)
39.0
± 14.8
AUCinf: Day 1
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I Only)
28.7
± 6.88
135 mg/m2/Week Dose (Phase I Only)
37.1
± 14.9
AUCinf: Day 15
Group
Value
95% CI
100 mg/m2/Week Dose (Phase I Only)
48.1
± 19.6
135 mg/m2/Week Dose (Phase I Only)
62.9
± 34.1
Adverse events — posted to ClinicalTrials.gov
Time frame: Phase I: From the Study Start Date to Phase I Completion (32 months) - Phase II: From Phase II start to Study Completion (23 months). Phase 2 started before Phase 1 completed..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a Phase I/II, open-label, non-randomized, multicenter study to explore safety, tolerability and antitumor activity of NMS-01940153E as single agent in adult patients with unresectable hepatocellular carcinoma (HCC) previously treated with systemic therapy.
The Phase I portion is designed as a dose-escalation study in sequential cohorts of patients aimed to obtain the maximum tolerated dose (MTD) that is defined based on the dose limiting toxicities (DLTs) observed in the first cycle of treatment.
The Phase II portion is designed as a two-stage study with an interim analysis for futility and stopping criteria for unacceptable toxicity to assess the antitumor activity of NMS-01940153E in adult patients with unresectable HCC previously treated with systemic therapy measured as objective response rate.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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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 Nerviano Medical Sciences
Last refreshed: 19 June 2025
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/NCT05630937.