Combination Immunotherapy for the Treatment of Chemotherapy-refractory Metastatic MSS CRC
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDan Feng
About this trial
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.
Eligibility criteria
Qualifiers
Patients must have a pathologically confirmed diagnosis of non-MSI-H/pMMR CRC.
Patients must have progressed (clinically or radiographically) on or after standard chemotherapy, including fluoropyrimidines, oxaliplatin, and irinotecan, or are intolerant to standard chemotherapy. Patients may have received, if eligible, anti-VEGF or anti-EGFR antibodies in combination with chemotherapy.
Patients must have at least 1 measurable target lesion at baseline ≥ 10mm in the longest diameter.
Patient must be willing and able to provide blood samples (6 heparinized, and two streck tubes, roughly 70 - 80 mL) at the time points indicated in the Study Calendar.
Disqualifiers
Patients who have had chemotherapy within 14 days from start of therapy.
Palliative radiotherapy is permitted at anytime, if deemed in the best interest of the patient.
Patients may not be receiving any other investigational agents.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring antibiotics (exception is a brief (≤10days) course of antibiotics to be completed before initiation of treatment), symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
Trial design
Treatments tested in this trial
- Nadunolimab
- Toripalimab
Treatment groups
24 Participants
are divided into 1 treatment groupSponsors and collaborators
Dan Feng
Lead sponsor
Icahn School of Medicine at Mount Sinai
Sponsor institution
Coherus Oncology, Inc.
Collaborator
Cantargia AB
Collaborator
Source ClinicalTrials.gov