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NCT04717375 · ClinicalTrials.gov registry record · Phase 1
Study of SAR444881 Administered Alone and in Combination With Other Therapeutics in Participants With Advanced Solid Tumors
A Phase 1 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 1
- Development phase
- 125
- Enrollment target
NCT04717375 is a Phase 1 study that was terminated before completion, run by Sanofi. The registered enrollment target is 125 participants.
The verdict
NCT04717375, a Phase 1 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 125 participants
- Enrollment target
Study Summary
The study will enroll advanced cancer patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy. The study will be comprised of two parts - a dose escalation phase (Part 1) and a dose optimization/expansion phase (Part 2). Part 1 is comprised of three sub-parts: SAR444881 administered alone (Sub-Part 1A), SAR444881 administered in combination with pembrolizumab (Sub-Part 1B), and SAR444881 administered in combination with cetuximab (Sub-Part 1C). Part 2 is composed of two sub-parts: a dose optimization part where up to two doses of SAR444881 per indication are administered in combination with pembrolizumab, cetuximab, and/or carboplatin and pemetrexed (Sub-Part 2A); and a dose expansion part where SAR444881 is administered alone (Sub-Part 2B). In Sub-Part 2A, a two-stage design will be implemented to conduct dose optimization for each indication with combination therapy- Stage 1 (Preliminary Assessment) and Stage 2 (Randomization). Study is non-randomized except Stage 2 of Sub-Part 2A which will use randomization.
Interventions
- DRUG Pembrolizumab
- DRUG Carboplatin
- DRUG Pemetrexed
- DRUG Cetuximab
- DRUG SAR444881
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2021-04-11 |
| Est. Completion | 2025-07-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04717375
The ClinicalTrials.gov registry entry for NCT04717375 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 125 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT04717375 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04717375 about?
NCT04717375 is a clinical study titled "Study of SAR444881 Administered Alone and in Combination With Other Therapeutics in Participants With Advanced Solid Tumors". The study will enroll advanced cancer patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy. The study will be comprised of two parts - a dose escalation phase (Part 1) and a dose optimization/expansion phase (Part 2). Part 1 is co...
What is the current status of trial NCT04717375?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 125 participants. The study started on 2021-04-11. Estimated completion is 2025-07-02.
What interventions are being tested in trial NCT04717375?
The interventions under investigation include: Pembrolizumab (DRUG), Carboplatin (DRUG), Pemetrexed (DRUG), Cetuximab (DRUG), SAR444881 (DRUG).
Who is sponsoring clinical trial NCT04717375?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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