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Combination Immunotherapy for the Treatment of Chemotherapy-refractory Metastatic MSS CRC

NCT07281716 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-02-19

No results posted yet for this 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.

Conditions

  • Metastatic Microsatellite Stable Colorectal Carcinoma

Interventions

DRUG

Nadunolimab

5 mg/kg intravenously (IV) every 3 weeks (Q3W)

DRUG

Toripalimab

240 mg IV every 3 weeks (Q3W)

Sponsors & Collaborators

  • Coherus Oncology, Inc.

    collaborator INDUSTRY

  • Cantargia AB

    collaborator INDUSTRY

  • Dan Feng

    lead OTHER

Principal Investigators

  • Dan Feng, MD, PhD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2028-12-15
Completion
2028-12-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07281716 on ClinicalTrials.gov