Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05630937 · ClinicalTrials.gov registry record · Phase 1
Study on Safety and Efficacy of NMS-01940153E in Adult Patients With Unresectable Hepatocellular Carcinoma (HCC) Previously Treated With Systemic Therapy
A Phase 1 study, sponsored by Nerviano Medical Sciences.
- Terminated
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT05630937: Clinical Trial Phase 1 study, sponsored by Nerviano Medical Sciences.
NCT05630937 is a Phase 1 study that was terminated before completion, run by Nerviano Medical Sciences. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05630937, a Phase 1 study, was terminated before completion, sponsored by Nerviano Medical Sciences.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Interventions
- DRUG NMS-01940153E
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2020-11-13 |
| Est. Completion | 2024-08-06 |
| Phase | Phase 1 |
Why NCT05630937 stopped before completion
NCT05630937 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 1 intervention - of which NMS-01940153E is the first listed.
NCT05630937 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05630937 about?
NCT05630937 is a clinical study titled "Study on Safety and Efficacy of NMS-01940153E in Adult Patients With Unresectable Hepatocellular Carcinoma (HCC) Previously Treated With Systemic Therapy". 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...
What is the current status of trial NCT05630937?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2020-11-13. Estimated completion is 2024-08-06.
What interventions are being tested in trial NCT05630937?
The interventions under investigation include: NMS-01940153E (DRUG).
Who is sponsoring clinical trial NCT05630937?
This trial is sponsored by Nerviano Medical Sciences, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05630937's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02932618 · 31 participants · Phase 3
A Study of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in Children With Severe Von Willebrand Disease (VWD)
- NCT03482297 · 31 participants · Phase 1
Automated Abdominal Binder for Orthostatic Hypotension
- NCT04016389 · 31 participants · NA
FIGO 2018 Stage IB2 Cervical Cancer Treated With Neoadjuvant Chemotherapy Followed by Fertility Sparing Surgery
- NCT04211675 · 31 participants · Phase 1
NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI