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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 is a Phase 1 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 13 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04747470
The ClinicalTrials.gov registry entry for NCT04747470 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Carboplatin is the first listed.
NCT04747470 reports 0 study locations.
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.
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