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NCT04834778 · ClinicalTrials.gov registry record · Phase 1
A Study of HC-5404-FU to Establish the Maximum Tolerated Dose (MTD)
A Phase 1 study, sponsored by HiberCell.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT04834778 is a Phase 1 study that has completed, run by HiberCell. The registered enrollment target is 23 participants.
The verdict
NCT04834778, a Phase 1 study, has completed, sponsored by HiberCell.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
Study HC-404-FCP-2011 is a first in human, Phase 1a, multi-center, open-label study to establish the maximum tolerated dose (MTD) and evaluate the safety and tolerability of oral dosing of HC-5404-FU in a dose-escalating fashion. Up to 36 qualified subjects at 3 to 5 US sites, who have specific tumor types of renal cell carcinoma (RCC), gastric cancer (GC), metastatic breast cancer (MBC), small cell lung cancer (SCLC), and other solid tumors (e.g., non-small cell lung cancer, colorectal cancer, carcinoma of unknown primary) with the exception of rapidly progressing neoplasms (e.g., pancreatic cancer, glioblastoma, hepatocellular carcinoma) will receive HC-5404-FU. Every effort will be made to ensure approximately 50% of all subjects enrolled will be subjects with RCC and GC. The starting dose level is 25 mg twice daily (BID), escalating to 50, 100, and 200 mg BID as safety allows, following the Bayesian Optimal Interval (BOIN) design. The safety monitoring committee (SMC) will evaluate the DLTs and cumulative safety and PK data at the end of each cohort. Based on the SMC recommendations after a comprehensive review of PK and safety data for 200 mg BID dose, higher dose levels will be evaluated, starting with 400 mg BID. The dose will escalate to 600 mg and then 900 mg following the BOIN design starting with 1 subject at each escalated dose, until the MTD is reached or the sponsor or SMC declares the dose most appropriate for clinical development. This Phase 1a will be expanded into a Phase 1b/2a study through a protocol amendment and will then assess the dose and tumor type(s) selected in Phase 1a as the most appropriate for further clinical development. Subjects will be dosed until unacceptable toxicity, disease progression per immune-related Response Evaluation Criteria in Solid Tumors (iRECIST), subject withdrawal, any other administrative reasons, or after 2 years of treatment, whichever occurs first. Efficacy will be assessed via Response Evaluation Criteria in
Interventions
- DRUG HC-5404-FU
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2021-06-08 |
| Est. Completion | 2024-01-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04834778
The ClinicalTrials.gov registry entry for NCT04834778 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 23 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-5404-FU is the first listed.
NCT04834778 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04834778 about?
NCT04834778 is a clinical study titled "A Study of HC-5404-FU to Establish the Maximum Tolerated Dose (MTD)". Study HC-404-FCP-2011 is a first in human, Phase 1a, multi-center, open-label study to establish the maximum tolerated dose (MTD) and evaluate the safety and tolerability of oral dosing of HC-5404-FU in a dose-escalating fashion. Up to 36 qualified subjects at 3 to 5 US sites, who have specific tumo...
What is the current status of trial NCT04834778?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2021-06-08. Estimated completion is 2024-01-30.
What interventions are being tested in trial NCT04834778?
The interventions under investigation include: HC-5404-FU (DRUG).
Who is sponsoring clinical trial NCT04834778?
This trial is sponsored by HiberCell, which has 11 total clinical trials registered on ClinicalTrials.gov.
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