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NCT03954704 · ClinicalTrials.gov registry record · Phase 1
Study of Dalutrafusp Alfa (Formerly GS-1423) in Participants With Advanced Solid Tumors
A Phase 1 study, sponsored by Gilead Sciences.
- Terminated
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT03954704 is a Phase 1 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 22 participants.
The verdict
NCT03954704, a Phase 1 study, was terminated before completion, sponsored by Gilead Sciences.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
For Phase 1a Part A, the primary objectives are to assess safety and tolerability and to define the dose limiting toxicity (DLT) and maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of dalutrafusp alfa (formerly GS-1423) monotherapy in participants with advanced solid tumors. For Phase 1a Part B, the primary objective is to assess safety and tolerability of dalutrafusp alfa monotherapy in participants with advanced solid tumors. For Phase 1b Cohort 1 safety run-in, the primary objective is to assess safety and tolerability and to define the DLT and MTD or RP2D of dalutrafusp alfa in combination with a chemotherapy regimen in participants with advanced gastric or gastroesophageal junction adenocarcinoma. For Phase 1b Cohort 1 post safety run-in, the primary objective is to assess the preliminary efficacy of dalutrafusp alfa in combination with a chemotherapy regimen in participants with advanced gastric or gastroesophageal junction adenocarcinoma, as assessed by the confirmed objective response rate (ORR). For Phase 1b Cohort 2, the primary objective is to assess safety and tolerability of dalutrafusp alfa monotherapy in participants with advanced solid tumors.
Interventions
- DRUG mFOLFOX6 Regimen
- DRUG Dalutrafusp alfa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2019-06-03 |
| Est. Completion | 2021-04-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03954704
The ClinicalTrials.gov registry entry for NCT03954704 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 22 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 2 interventions - of which mFOLFOX6 Regimen is the first listed.
NCT03954704 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03954704 about?
NCT03954704 is a clinical study titled "Study of Dalutrafusp Alfa (Formerly GS-1423) in Participants With Advanced Solid Tumors". For Phase 1a Part A, the primary objectives are to assess safety and tolerability and to define the dose limiting toxicity (DLT) and maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of dalutrafusp alfa (formerly GS-1423) monotherapy in participants with advanced solid tumors. For Pha...
What is the current status of trial NCT03954704?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2019-06-03. Estimated completion is 2021-04-15.
What interventions are being tested in trial NCT03954704?
The interventions under investigation include: mFOLFOX6 Regimen (DRUG), Dalutrafusp alfa (DRUG).
Who is sponsoring clinical trial NCT03954704?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
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