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

NCT07277322 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-04-29

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Toripalimab

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.

DRUG

Dupilumab

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).

Sponsors & Collaborators

  • Coherus Oncology, Inc.

    collaborator INDUSTRY

  • Dan Feng

    lead OTHER

Principal Investigators

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

  • Thomas Marron, 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
2026-06-01
Primary Completion
2028-12-31
Completion
2030-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT07277322 on ClinicalTrials.gov