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NCT07281716 · ClinicalTrials.gov registry record · Phase 1
Combination Immunotherapy for the Treatment of Chemotherapy-refractory Metastatic MSS CRC
A Phase 1 study of Metastatic Microsatellite Stable Colorectal Carcinoma, sponsored by Dan Feng.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT07281716: Recruiting Phase 1 study of Metastatic Microsatellite Stable Colorectal Carcinoma, sponsored by Dan Feng.
NCT07281716 is a Phase 1 study of Metastatic Microsatellite Stable Colorectal Carcinoma that is actively recruiting participants, run by Dan Feng. The registered enrollment target is 24 participants, below the 35-participant average among 6 other Metastatic Microsatellite Stable Colorectal Carcinoma trials with a reported enrollment target (31% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07281716, a Phase 1 study of Metastatic Microsatellite Stable Colorectal Carcinoma, is actively recruiting participants, sponsored by Dan Feng.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
Phase 1b/2 open-label study evaluates the safety, tolerability, and efficacy of combination immunotherapy with nadunolimab (anti-IL-1RAP) and toripalimab (anti-PD-1) in patients with chemotherapy-refractory metastatic microsatellite stable (MSS) colorectal cancer. Phase 1b will assess dose-limiting toxicity (DLT), while Phase 2 will evaluate objective response rate (ORR), including progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and duration of response (DOR). Exploratory analyses will investigate immunomodulatory effects through tumor and peripheral blood studies, and treatment will continue every 3 weeks for up to 1 year or until disease progression.
Primary Outcome
For the Phase 1b portion, Dose-Limiting Toxicities (DLTs) will be assessed based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Adverse events are graded on a scale from 1 (mild) to 5 (death related to AE). Permanent discontinuation of study treatment will occur for any severe (Grade 3) drug-related adverse event that recurs or for any life-threatening (Grade 4) event.
Conditions Studied
Interventions
- DRUG Toripalimab
- DRUG Nadunolimab
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2025-12-01 |
| Est. Completion | 2028-12-15 |
| Phase | Phase 1 |
What NCT07281716 shows while recruiting
NCT07281716 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 35-participant average among 6 other Metastatic Microsatellite Stable Colorectal Carcinoma trials with a reported enrollment target (31% lower).
The record links to 1 condition, with Metastatic Microsatellite Stable Colorectal Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Toripalimab is the first listed.
NCT07281716 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT07281716 about?
NCT07281716 is a clinical study titled "Combination Immunotherapy for the Treatment of Chemotherapy-refractory Metastatic MSS CRC". Phase 1b/2 open-label study evaluates the safety, tolerability, and efficacy of combination immunotherapy with nadunolimab (anti-IL-1RAP) and toripalimab (anti-PD-1) in patients with chemotherapy-refractory metastatic microsatellite stable (MSS) colorectal cancer. Phase 1b will assess dose-limiting ...
What is the current status of trial NCT07281716?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2025-12-01. Estimated completion is 2028-12-15.
What conditions does trial NCT07281716 study?
This clinical trial studies the following conditions: Metastatic Microsatellite Stable Colorectal Carcinoma.
What interventions are being tested in trial NCT07281716?
The interventions under investigation include: Toripalimab (DRUG), Nadunolimab (DRUG).
Who is sponsoring clinical trial NCT07281716?
This trial is sponsored by Dan Feng, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07281716 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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