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NCT02991196 · ClinicalTrials.gov registry record · Phase 1
Antibody DS-8273a Administered in Combination With Nivolumab in Subjects With Advanced Colorectal Cancer
A Phase 1 study, sponsored by Daiichi Sankyo.
- Terminated
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT02991196: Clinical Trial Phase 1 study, sponsored by Daiichi Sankyo.
NCT02991196 is a Phase 1 study that was terminated before completion, run by Daiichi Sankyo. The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02991196, a Phase 1 study, was terminated before completion, sponsored by Daiichi Sankyo.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
This trial is being performed in two parts: Dose Escalation and Dose Expansion. The primary objective for the Dose Escalation part is to determine the safety and tolerability at different doses of DS-8273a administered in combination with nivolumab and to identify the dose combination for the Dose Expansion cohort in subjects with mismatch repair (MMR)-proficient advanced colorectal cancer. The primary objectives for the Dose Expansion part are: * To further evaluate the safety and tolerability of DS-8273a administered at the selected dose in combination with nivolumab in subjects with MMR-proficient advanced colorectal cancer * To evaluate preliminary anti-tumor activity of DS-8273a plus nivolumab administered at the selected dose in subjects with MMR-proficient advanced colorectal cancer
Primary Outcome
A DLT is defined as a study drug-related ≥ Grade 3 Adverse Event (AE) occurring during the first cycle (28 days) of treatment, with specific exceptions for hematologic events, elevations in hepatic function enzymes, and adverse events that are pre-identified as not being DLTs.
Interventions
- DRUG DS-8273a + nivolumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2016-12-01 |
| Est. Completion | 2017-09-22 |
| Phase | Phase 1 |
Why NCT02991196 stopped before completion
NCT02991196 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which DS-8273a + nivolumab is the first listed.
NCT02991196 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02991196 about?
NCT02991196 is a clinical study titled "Antibody DS-8273a Administered in Combination With Nivolumab in Subjects With Advanced Colorectal Cancer". This trial is being performed in two parts: Dose Escalation and Dose Expansion. The primary objective for the Dose Escalation part is to determine the safety and tolerability at different doses of DS-8273a administered in combination with nivolumab and to identify the dose combination for the Dose ...
What is the current status of trial NCT02991196?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2016-12-01. Estimated completion is 2017-09-22.
What interventions are being tested in trial NCT02991196?
The interventions under investigation include: DS-8273a + nivolumab (DRUG).
Who is sponsoring clinical trial NCT02991196?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02991196's enrollment target sits among peer trials
4 1995th of 2000 higher than 2 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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