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NCT03250832 · ClinicalTrials.gov registry record · Phase 1
Study of TSR-033 With an Anti-programmed Cell Death-1 Receptor (PD-1) in Participants With Advanced Solid Tumors
A Phase 1 study, sponsored by Tesaro.
- Completed
- Registry status
- Phase 1
- Development phase
- 111
- Enrollment target
NCT03250832 is a Phase 1 study that has completed, run by Tesaro. The registered enrollment target is 111 participants.
The verdict
NCT03250832, a Phase 1 study, has completed, sponsored by Tesaro.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 111 participants
- Enrollment target
Study Summary
This is a multicenter, open-label, first-in-human Phase 1 study evaluating the anti-lymphocyte activation gene-3 (LAG-3) antibody TSR-033 alone, in combination with the anti-PD-1 antibody dostarlimab, and in combination with dostarlimab, modified folinic acid (FOL)/leucovorin, 5-fluorouracil and oxaliplatin (OX) (mFOLFOX6) or FOL/leucovorin, 5-fluorouracil and irinotecan (IRI) (FOLFIRI), and bevacizumab in participants with advanced solid tumors in a broad range of solid tumors. Participants with disease types selected for evaluation in this study are expected to derive clinical benefit with addition of an anti-PD-1. The study will be conducted in two parts with Part 1 consisting of dose escalation to determine the recommended phase 2 dose (RP2D) of TSR-033 as a single agent (Part 1a) and in combination with dostarlimab (Part 1c). RP2D decisions will be based on the occurrence of dose-limiting toxicities (DLTs), pharmacokinetics (PK), as well as pharmacodynamics (PDy) data. Part 2A of the study will investigate the anti-tumor activity of TSR-033 and dostarlimab in combination in participants with advanced or metastatic microsatellite stable colorectal cancer (MSS-CRC). Part 2B of the study will investigate the safety and anti-tumor activity of TSR-033 and dostarlimab in combination with chemotherapy (Cohort B1: mFOLFOX6 and Cohort B2: FOLFIRI) and bevacizumab in participants with advanced or metastatic MSS-CRC.
Interventions
- DRUG Bevacizumab
- DRUG FOLFIRI
- DRUG Dostarlimab
- DRUG mFOLFOX6
- DRUG TSR-033
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2017-08-08 |
| Est. Completion | 2023-02-13 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03250832
The ClinicalTrials.gov registry entry for NCT03250832 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 111 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tesaro, which has 26 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Bevacizumab is the first listed.
NCT03250832 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03250832 about?
NCT03250832 is a clinical study titled "Study of TSR-033 With an Anti-programmed Cell Death-1 Receptor (PD-1) in Participants With Advanced Solid Tumors". This is a multicenter, open-label, first-in-human Phase 1 study evaluating the anti-lymphocyte activation gene-3 (LAG-3) antibody TSR-033 alone, in combination with the anti-PD-1 antibody dostarlimab, and in combination with dostarlimab, modified folinic acid (FOL)/leucovorin, 5-fluorouracil and oxa...
What is the current status of trial NCT03250832?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 111 participants. The study started on 2017-08-08. Estimated completion is 2023-02-13.
What interventions are being tested in trial NCT03250832?
The interventions under investigation include: Bevacizumab (DRUG), FOLFIRI (DRUG), Dostarlimab (DRUG), mFOLFOX6 (DRUG), TSR-033 (DRUG).
Who is sponsoring clinical trial NCT03250832?
This trial is sponsored by Tesaro, which has 26 total clinical trials registered on ClinicalTrials.gov.
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