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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: Completed Phase 1 study, sponsored by Tesaro.
NCT03250832 is a Phase 1 study that has completed, run by Tesaro. The registered enrollment target is 111 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
DLTs were assessed based on common terminology criteria for adverse events (CTCAE) v5.0 included drug-related AEs like grade\>=2 uveitis, eye pain, or blurred vision that does not resolve with topical therapy within 2 weeks, grade ≥2 immune-related endocrine toxicity that required hormone replacement, grade 2 or 3 colitis or diarrhea that persisted without resolution to grade\<=1 for \>=7days despite adequate immune suppressive therapy, grade 3 or 4 immune-related AEs (irAE) without resolution t
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 |
What the finished NCT03250832 record still lists
NCT03250832 is an interventional study that assigns participants to a tested intervention. The registered 111 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% higher).
The record links to 0 conditions, and to 5 interventions - of which Bevacizumab is the first listed.
NCT03250832 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03250832's enrollment target sits among peer trials
111 512th of 2000 higher than 1,487 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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