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NCT04747470 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Effects of GS-3583 in Participants With Advanced Solid Tumors
A Phase 1 study, sponsored by Gilead Sciences.
- Terminated
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT04747470: Clinical Trial Phase 1 study, sponsored by Gilead Sciences.
NCT04747470 is a Phase 1 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04747470, a Phase 1 study, was terminated before completion, sponsored by Gilead Sciences.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
This study is planned to be conducted in 2 parts: Part 1: Dose Escalation and Part 2: Safety Run-In and Randomized Expansion. The primary objectives of Part 1 are 1) To characterize the safety and tolerability of GS-3583 as monotherapy in participants with advanced solid tumors. 2) To determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of GS-3583 as monotherapy in participants with advanced solid tumors. The primary objectives of Part 2 is to assess the safety and tolerability and to determine the RP2D of GS-3583 in combination with zimberelimab (ZIM) and platinum (cisplatin or carboplatin) + 5-fluorouracil (5-FU) chemotherapy in participants with head and neck squamous cell carcinoma (HNSCC) (Cohort A) or in combination with docetaxel in participants with non-small cell lung cancer (NSCLC) (Cohort B).
Primary Outcome
DLT was defined as any toxicity (hematologic, non-hematologic, dosing/procedures-related toxicities, or grade 5 event (ie death)) occurring with GS-3583 monotherapy during the DLT assessment period (from Day 1 up to Day 28) considered at least possibly related to GS-3583 monotherapy.
Interventions
- DRUG Carboplatin
- DRUG Cisplatin
- DRUG Zimberelimab
- DRUG 5-Fluorouracil
- DRUG GS-3583
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2021-03-25 |
| Est. Completion | 2022-11-07 |
| Phase | Phase 1 |
Why NCT04747470 stopped before completion
NCT04747470 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 5 interventions - of which Carboplatin is the first listed.
NCT04747470 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04747470 about?
NCT04747470 is a clinical study titled "Study to Assess the Effects of GS-3583 in Participants With Advanced Solid Tumors". This study is planned to be conducted in 2 parts: Part 1: Dose Escalation and Part 2: Safety Run-In and Randomized Expansion. The primary objectives of Part 1 are 1) To characterize the safety and tolerability of GS-3583 as monotherapy in participants with advanced solid tumors. 2) To determine the...
What is the current status of trial NCT04747470?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2021-03-25. Estimated completion is 2022-11-07.
What interventions are being tested in trial NCT04747470?
The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Zimberelimab (DRUG), 5-Fluorouracil (DRUG), GS-3583 (DRUG).
Who is sponsoring clinical trial NCT04747470?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04747470's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 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
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