Neoadjuvant Dupilumab and Toripalimab in MSS CRC Subjects With Resectable Liver Metastases

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

Sponsor
Dan Feng
Study ID
NCT07277322
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Liver Metastases
  • Metastatic Colorectal Cancer

Eligibility Criteria

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

Interventions

  • Dupilumab — DRUG
    Dupilumab is commercially sourced, and provided as 300mg pre-filled syringes, though packaging may vary. Dupilumab 600mg SC on Day 1 and 300mg SC on Day 15 (+/-2 days).
  • Toripalimab — DRUG
    Toripalimab will be supplied as a liquid in sterile, single-use vials that will display the product lot number on the label. Each vial contains 240 mg/6 mL (40 mg/mL) solution. Toripalimab 240mg IV over 60 minutes or longer on Day 1 before planned surgery.

Study Details

This Phase 1b/2 trial will evaluate the safety and efficacy of neoadjuvant immunotherapy in microsatellite stable (MSS) colorectal cancer (CRC) subjects with resectable liver metastases.

Key Dates

First listed
Dec 11, 2025
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2030

Study Design

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

Arms

  • Experimental: Dupilumab and toripalimab
    Participants will receive the combination of Dupilumab and Toripalimab

Primary Outcome Measure

Number of dose limiting toxicities (DLTs) [ Time Frame: up to 30 days post last administration of study drug dupilumab ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Lisa Fitzgerald
[email protected]
(917) 748-0962
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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