Phase II Study of Ivonescimab for Metastatic Colorectal Cancer
This study is testing a drug called ivonescimab (given by IV) in people with metastatic colorectal cancer that has been treated before. The goal is to see how well ivonescimab works to control the cancer and if it is safe. To join, you must be at least 18 years old and have confirmed metastatic colorectal cancer. Your cancer's MMR or MSI status (types of genetic markers) must also be known. The study will look at how many people respond to the treatment and how long that response lasts. Researchers are also interested in how safe ivonescimab is for patients.
- Study design
- This is a Phase II interventional study planning to enroll 90 participants. It is testing ivonescimab in different groups of patients with metastatic colorectal cancer.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety and adverse events will be measured through study completion, which is an average of 1 year.
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NCT06959550
Phase II Study of Anti-PD-1/VEGF Bispecific Antibody Ivonescimab in Patients With Previously Treated Metastatic Colorectal Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentM.D. Anderson Cancer CenterInvestigator-initiated
~90 participants
Updated 2026-05-20 on ClinicalTrials.gov
What's tested:Ivonescimab
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
1. Safety and Adverse Events (AEs)
Measured over Through study completion; an average of 1 year
Conditions
Where it's being run
1 sites across 1 statesTexas1
Study leadership
- Saurav Haldar, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Cohort 1: MSI-H/dMMR: ICI-refractory
dMMR or MSI-H per local testing
Demonstrated radiographic or clinical disease progression following treatment with immune checkpoint inhibitors including anti-PD-1 +/- anti-CTLA-4 therapy. If progression occurred after first imaging assessment, then pseudo-progression should be excluded by concurrent carcinoembryonic antigen (CEA) or other tumor marker or ctDNA elevation, or clinical symptom progression, or short-interval repeat imaging confirming progression.
Must have received at least 2 doses of a PD1/PD-L1 inhibitor.
Progressive disease either during therapy or within 3 months of last dose of therapy.
No serious adverse immune-related adverse events (grade 3 or higher) with previous immune checkpoint therapy, that were symptomatic and required prolonged immunosuppression (\>6 weeks).
Cohort 2: pMMR with liver metastases
pMMR or non-MSI-H per local testing
Presence of active liver metastases per radiographic imaging
Patients with any bulky liver metastases measuring \>5.0 cm are not eligible
Cohort 3: pMMR without liver metastases
pMMR or non-MSI-H per local testing
No liver metastases per radiographic imaging (note: previously treated or resected liver metastases are allowed if treatment was \>6 months prior without liver progression) 6. Known extended RAS and BRAF status as per local standard of practice (Cohorts 2 and 3 only) 7. Participant must have progressed (radiologically or clinically) or been intolerant to fluoropyrimidine, irinotecan, and oxaliplatin (Cohorts 2 and 3 only)
Patient must have evidence of progression on or after the last treatment regimen received and within 6 months prior to study enrollment
Patients who were intolerant to prior systemic chemotherapy regimens are eligible if there is documented evidence of clinically significant intolerance despite adequate supportive measures.
Perioperative chemotherapy exposure can be considered if the participant had disease recurrence within 12 months of completion of neoadjuvant chemotherapy or 6 months of completion of adjuvant chemotherapy 8. ECOG (Eastern Cooperative Oncology Group) PS of 0 to 1. 9. Adequate hematologic and organ function as assessed by the following laboratory tests performed within 7 days before treatment initiation:
Total bilirubin .1.5 x the upper limit of normal (ULN). Total bilirubin (.3 x ULN) is allowed if Gilbert fs syndrome is documented.
Alanine transaminase (ALT) and aspartate aminotransferase (AST) .2.5x ULN (.5 x ULN for patients with liver involvement of their cancer)
Platelet count .100,000 /mm3, Hemoglobin (Hb) .9 g/dL, WBC .2000/ƒÊL absolute neutrophil count (ANC) .1500/mm3 without red blood cell transfusion or growth factor administered within 7 days of screening CBC.
Serum creatinine .1.5 x ULN or creatinine clearance .50 mL/min (measured or calculated using the Cockroft-Gault formula)
Prothrombin time-international normalized ratio (PT/INR) . 1.5 x ULN and partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) . 1.5 \~ ULN (unless abnormalities are unrelated to coagulopathy) This applies only to patients who are not on therapeutic anti-coagulation. Patients receiving therapeutic anti-coagulation should be on a stable dose.
Estimated CrCl . 50 mL/min.
Proteinuria . 30 mg/dL. 10. Measurable disease as determined by iRECIST v1.1. 11. Ability to provide recent tumor tissue is mandatory for all participants at screening, either through pre-treatment biopsy or archived tissue. For archived tissue, FFPE block or a minimum of 10 slides is recommended with exceptions to these criteria permitted for consideration by the principal investigator. 12. Anticipated life expectancy greater than 3 months 13. Women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of study intervention and 4 months after the last dose of study drug. Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of study intervention and 4 months after the last dose of study drug. In addition, male participants must be willing to refrain from sperm donation during this time. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Hemoptysis (defined as coughing up . 0.5 teaspoon of fresh blood or small blood clots. Note: transient hemoptysis associated with diagnostic bronchoscopy is allowed
Nasal bleeding/epistaxis (bloody nasal discharge is allowed)
Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable prior to enrollment is not permitted. The use of full-dose anticoagulants is permitted if the international normalized ratio (INR) or activated partial thromboplastin time (aPTT) is within therapeutic limits according to the medical standard of the enrolling institution. 14. Subjects whose tumors invade peripheral important organs and blood vessels (such as heart and pericardium, trachea, esophagus, aorta, superior vena cava, etc), and who are at risk of esophageal tracheal fistula or esophageal pleural fistula or intestinal fistula 15. Symptomatic CNS metastases, CNS metastases with hemorrhagic features, CNS metastasis . 1.5 cm, CNS radiation within 7 days prior to randomization, potential need for CNS radiation within the first cycle, or leptomeningeal disease. Note: Patients must have stopped corticosteroids or be on physiologic corticosteroid replacement therapy (prednisone .10 mg daily or equivalent). 16. Live vaccine or live attenuated vaccine within 4 weeks prior to planned enrollment, or if scheduled to receive a live vaccine or live attenuated vaccine during the study period. Inactivated vaccines are permitted. 17. Severe infection within 4 weeks prior to enrollment, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; active infection (as determined by the investigator) requiring systemic anti-infective therapy within 2 weeks prior to enrollment. Participants with HIV, HCV, or HBV infection may be included if suppressive antiviral therapy has been administered and the viral load is undetectable. 18. Has pre-existing peripheral neuropathy that is . grade 2 per NCI CTCAE v5.0. 19. Major surgical procedures or serious trauma within 4 weeks prior to enrollment, or plans for major surgical procedures within 4 weeks after the first dose (as determined by the investigator). Minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior to enrollment. 20. Uncontrolled pleural effusions, pericardial effusions, or ascites that is clinically symptomatic. Note: Patients managed with indwelling catheters (e.g. PleurX) are allowed. 21. History of non-infectious pneumonia requiring systemic corticosteroids, or current interstitial lung disease 22. Active or prior history of inflammatory bowel disease (eg, Crohn fs disease, ulcerative colitis, or chronic diarrhea) 23. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation 24. Known allergy to any component of any study drug or known history of severe hypersensitivity to other monoclonal antibodies 25. Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with participation in the trial or interfere with the interpretation of trial results, in the opinion of the investigator. 26. Participants with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses \>10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. 27. Pregnancy or breast feeding. 28. Psychological, familial, or sociological condition potentially hampering compliance with the study protocol and follow-up schedule.
What this trial measures
- 1. Safety and Adverse Events (AEs)Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0