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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 is a Phase 1 study that was terminated before completion, run by Nerviano Medical Sciences. The registered enrollment target is 31 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05630937
The ClinicalTrials.gov registry entry for NCT05630937 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nerviano Medical Sciences, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which NMS-01940153E is the first listed.
NCT05630937 reports 0 study locations.
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.
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