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

Part of paid clinical trials in New York, New York.

Sponsor
Dan Feng
Study ID
NCT07281716
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Metastatic Microsatellite Stable Colorectal Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nadunolimab — DRUG
    5 mg/kg intravenously (IV) every 3 weeks (Q3W)
  • Toripalimab — DRUG
    240 mg IV every 3 weeks (Q3W)

Study Details

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.

Key Dates

Start date
Dec 1, 2025
Status verified
Dec 2025
Primary completion
Dec 15, 2028
Completion
Dec 15, 2028

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Nadunolimab and Toripalimab
    Participants will receive the investigational combination of nadunolimab and toripalimab. Treatment will continue for up to 1 year or until disease progression, whichever occurs first.

Primary Outcome Measure

Dose-Limiting Toxicities (DLTs) [ Time Frame: The first cycle (day1 - day21) constitutes the DLT window. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Jordan Cuevas
[email protected]
(212) 824-7945
Rashmi Unawane
[email protected]
212-824-2385
Dan Feng (PRINCIPAL_INVESTIGATOR)

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By research site
Icahn School of Medicine at Mount Sinai· New York, NY

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