Neoadjuvant Dupilumab and Toripalimab in MSS CRC Subjects With Resectable Liver Metastases (NCT07277322) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Neoadjuvant Dupilumab and Toripalimab in MSS CRC Subjects With Resectable Liver Metastases
United States24 participantsStarted 2026-06-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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
Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception upon study entry, for the duration of study participation, and for 3 months following completion of therapy.
* A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, …
What they're measuring
1
Number of dose limiting toxicities (DLTs)
Timeframe: up to 30 days post last administration of study drug dupilumab