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Neoadjuvant Dupilumab and Toripalimab in MSS CRC Subjects With Resectable Liver Metastases | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE1/PHASE2

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

Master Protocol for A Phase 1b/2 Study of Neoadjuvant Immunotherapy in Microsatellite Stable (MSS) Colorectal Cancer (CRC) Subjects With Resectable Liver Metastases

NCT07277322•Dan Feng

View on ClinicalTrials.gov

Summary

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.

Detailed Description

This is a Phase 1b/2 study of neoadjuvant dupilumab and toripalimab in MSS CRC subjects with resectable liver metastases. The primary objective of Phase 1b is to determine the safety of neoadjuvant immunotherapy in MSS CRC subjects with resectable liver metastases. The primary objective of Phase 2 is to determine the efficacy of immunotherapy in MSS CRC subjects with resectable liver metastases as measured by the percentage of subjects achieving a major pathological response (MPR). Eligible subjects will receive dupilumab (600mg on Day 1 and 300mg on D15 ±2 days) and toripalimab 240mg on Day 1 before planned surgery. Dupilumab is administered as a subcutaneous injection. Toripalimab is administered intravenously over 60 minutes or longer. Based on clinical signal in the current cohort and new findings in animal models, additional cohorts will be added to test different immunotherapy combinations in the same patient population with the same endpoints and statistical method in the future.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histological diagnosis of non-MSI-H/pMMR CRC
•Subjects who have biology-proven non-MSI-H/pMMR CRC and with radiographic findings suggestive of liver metastases may be eligible.
•Resectable liver metastases including:
•synchronous liver metastases (present at the time of diagnosis of MSS CRC) and treatment-naïve
•metachronous liver metastasis (developed after resection of the primary tumor) without prior adjuvant chemotherapy
•metachronous liver metastasis (developed after resection of the primary tumor) with adjuvant chemotherapy completed greater than 3 months from the time of consent.
•Surgical candidate for resection
•Age ≥ 18 years. Rationale: Because no dosing or adverse event data are currently available on the use of dupilumab in combination with toripalimab in subjects \<18 years of age, children are excluded from this study.
•ECOG Performance Status 0-1 (Karnofsky ≥60%,)
•Subjects with performance status \>1 carrying long-term disability (such as cerebral palsy) where the disability is not acute nor progressive, and unlikely to significantly affect their response to therapy may be enrolled at the investigator's discretion
+17 more criteria

Exclusion Criteria

•History of autoimmune disorder with the following exceptions:
•Vitiligo, alopecia, psoriasis or any chronic skin condition that does not require systemic therapy
•Hypothyroidism (e.g. following autoimmune thyroiditis) stable on thyroid replacement
•Celiac disease controlled by diet alone
•Treatment, for any reason, with an immunomodulatory drug, within 8 weeks from time of consent.
•Prior treatment with dupilumab within the last 8 weeks.
•Prior treatment with chemotherapy for MSS CRC or locoregional therapy to the target lesion (that will be biopsied and subsequently resected) within 3 months prior to entering the study.
•Previous therapy for a different cancer (a different primary) is acceptable.
•Use of investigational agents for treatment of cancer.
•Subjects with extrahepatic metastases that are not amendable to resectable or locoregional therapy, for whom the intent of surgery would not be curative.
+15 more criteria

Locations (1)

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Key Dates

Start Date

March 15, 2026

Primary Completion Date

December 31, 2028

Completion Date

December 31, 2030

Last Updated

March 2, 2026

Enrollment

ESTIMATED participants

Conditions

Metastatic Colorectal CancerLiver Metastases

Interventions

Dupilumab

DRUG

Toripalimab

DRUG

Contacts

Lisa Fitzgerald

CONTACT

(917) 748-0962 lisa.fitzgerald@mssm.edu

Rashmi Unawane

CONTACT

(212) 824-2385 rashmi.unawane@mssm.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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