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NCT05121948 · ClinicalTrials.gov registry record · Phase 1
A Study of HC-7366 to Establish the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)
A Phase 1 study, sponsored by HiberCell.
- Terminated
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
NCT05121948 is a Phase 1 study that was terminated before completion, run by HiberCell. The registered enrollment target is 35 participants.
The verdict
NCT05121948, a Phase 1 study, was terminated before completion, sponsored by HiberCell.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
Study Summary
This is a first in human, multicenter, open label, Phase 1a and 1b dose-escalation and dose-expansion study to establish the maximum tolerated dose, recommended Phase 2 dose, and evaluate the safety and tolerability of QD oral dosing of HC 7366 in a dose escalating fashion in subjects with advanced solid tumors. Up to 40 subjects will be enrolled into the Phase 1a dose-escalation part of the study. The study will be conducted in the United States at approximately 7 to 10 sites. Every effort will be made to ensure approximately 50% of all subjects enrolled into Phase 1a of this study are subjects with the tumors of special interest including squamous cell carcinoma of the head and neck, colorectal cancer, non-small cell lung cancer, and transitional cell carcinoma of the bladder. Subjects with other solid tumor types are also eligible provided study selection criteria are met and they do not exceed 50% of all enrolled subjects. All subjects in Phase 1b will enroll with clear cell renal cell carcinoma. The Phase 1a study will follow a traditional 3+3 design. The starting dose level will be 10 mg QD, escalating to 20, 40, 75, 125, and 150 mg QD as safety allows. All doses are to be administered in the fasting state with water at least 1 hour before food or at least 2 hours after food. The Phase 1b dose-expansion will be at a single dose level of 75 mg based on the safety, tolerability, PK/PD results from Phase 1a to obtain additional safety and preliminary efficacy information. At the discretion of the safety monitoring committee and sponsor, the cohort may be expanded to enroll additional patients and/ or 1-2 additional cohorts will be opened. Up to 30 subjects may be enrolled in the Phase 1b portion of the study at the 75 mg dose. Replacement patients will be enrolled if necessary. Subjects will be dosed until unacceptable toxicity, disease progression per immune-related Response Evaluation Criteria in Solid Tumors, discontinuation of treatment for other protocol all
Interventions
- DRUG HC-7366
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2022-02-23 |
| Est. Completion | 2024-03-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05121948
The ClinicalTrials.gov registry entry for NCT05121948 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is HiberCell, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which HC-7366 is the first listed.
NCT05121948 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05121948 about?
NCT05121948 is a clinical study titled "A Study of HC-7366 to Establish the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)". This is a first in human, multicenter, open label, Phase 1a and 1b dose-escalation and dose-expansion study to establish the maximum tolerated dose, recommended Phase 2 dose, and evaluate the safety and tolerability of QD oral dosing of HC 7366 in a dose escalating fashion in subjects with advanced ...
What is the current status of trial NCT05121948?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2022-02-23. Estimated completion is 2024-03-01.
What interventions are being tested in trial NCT05121948?
The interventions under investigation include: HC-7366 (DRUG).
Who is sponsoring clinical trial NCT05121948?
This trial is sponsored by HiberCell, which has 11 total clinical trials registered on ClinicalTrials.gov.
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