Actively Recruiting
Phase II Study of Anti-PD-1/VEGF Bispecific Antibody Ivonescimab in Patients With Previously Treated Metastatic Colorectal Cancer
Led by M.D. Anderson Cancer Center · Updated on 2026-05-05
90
Participants Needed
1
Research Sites
257 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
A
Akesobio Australia Pty Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical research study is to learn if ivonescimab can help to control previously treated, metastatic colorectal cancer.
CONDITIONS
Official Title
Phase II Study of Anti-PD-1/VEGF Bispecific Antibody Ivonescimab in Patients With Previously Treated Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give signed informed consent
- Male or female adults 18 years or older
- Confirmed advanced, metastatic adenocarcinoma of colon or rectum
- Known MMR or MSI status by local testing
- Meet specific criteria for one of three cohorts: 1) MSI-H/dMMR refractory to immune checkpoint inhibitors, 2) pMMR with liver metastases (none larger than 5.0 cm), 3) pMMR without liver metastases
- Known extended RAS and BRAF status for cohorts 2 and 3
- Progressed or intolerant to fluoropyrimidine, irinotecan, and oxaliplatin chemotherapy (cohorts 2 and 3)
- ECOG performance status of 0 to 1
- Adequate blood counts and organ function within 7 days before treatment
- Measurable disease by iRECIST v1.1
- Ability to provide recent tumor tissue or archived tissue samples
- Life expectancy greater than 3 months
- Women of childbearing potential and sexually active males agree to use contraception during and 4 months after treatment
You will not qualify if you...
- Any single liver metastasis larger than 5.0 cm (cohort 2 only)
- Prior PD-1, PD-L1, or CTLA-4 inhibitor therapy except for MSI-H/dMMR tumors (cohorts 2 and 3)
- Discontinued immune checkpoint inhibitors due to certain grade 2 adverse events (cohort 1)
- Systemic anti-cancer treatment within 14 days or less than 5 half-lives before first study dose
- Unresolved significant toxicity from prior therapies (grade 2 or higher)
- Recent serious cardiovascular events or unstable heart conditions within 12 months
- Acute worsening of chronic obstructive pulmonary disease within 4 weeks
- Poorly controlled high blood pressure despite medication
- Active autoimmune or lung disease requiring systemic therapy within 2 years (with some exceptions)
- Recent severe gastrointestinal conditions or bleeding within 6 months
- History of bleeding disorders or significant bleeding risk within 4 weeks
- Tumors invading critical organs or blood vessels with fistula risk
- Symptomatic or large CNS metastases, recent CNS radiation, or leptomeningeal disease
- Live vaccine within 4 weeks before or planned during the study
- Severe infection or active infection requiring treatment within recent weeks
- Pre-existing peripheral neuropathy grade 2 or higher
- Major surgery or serious trauma within 4 weeks before enrollment
- Uncontrolled symptomatic effusions or ascites
- History of non-infectious pneumonia requiring steroids or interstitial lung disease
- History of inflammatory bowel disease
- History of organ or hematopoietic stem cell transplantation
- Known allergy to study drugs or severe monoclonal antibody hypersensitivity
- Other significant medical or psychiatric conditions interfering with participation
- Use of systemic corticosteroids or immunosuppressive medications within 14 days before treatment
- Pregnancy or breastfeeding
- Psychological or social conditions interfering with study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
S
Saurav Haldar, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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