RecruitingPhase 2

Phase II Study of Anti-PD-1/VEGF Bispecific Antibody Ivonescimab in Patients With Previously Treated Metastatic Colorectal Cancer

United States90 participantsStarted 2025-07-28

Plain-language summary

The goal of this clinical research study is to learn if ivonescimab can help to control previously treated, metastatic colorectal cancer.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Capable of giving signed informed consent
✓. Male and female adult participants 18 years of age or older on day of signing informed consent.
✓. Histological or cytological confirmed advanced, metastatic adenocarcinoma of colon or rectum.
✓. Known MMR or MSI status performed by local standard of practice. (e.g., IHC and/or PCR, next-generation sequencing)
✓. Cohort-specific criteria
✓. Known extended RAS and BRAF status as per local standard of practice (Cohorts 2 and 3 only)
✓. Participant must have progressed (radiologically or clinically) or been intolerant to fluoropyrimidine, irinotecan, and oxaliplatin (Cohorts 2 and 3 only)
✓. ECOG (Eastern Cooperative Oncology Group) PS of 0 to 1.

Exclusion criteria

✕. Any single liver metastasis \>5.0 cm (Cohort 2 only)
✕. Except for MSI-H/dMMR tumors, prior therapy with PD-1, PD-L1, or CTLA-4 inhibitors (Cohorts 2 and 3 only).
✕. Patient who discontinued prior therapy with immune checkpoint inhibitors due to Grade 2 neurologic, cardiac, or ophthalmologic events or recurrent Grade 2 pneumonitis are not eligible for the trial (Cohort 1 only).
✕. Systemic anti-cancer treatment within 14 days or less than 5 half-lives (whichever is shorter) of the first dose of study treatment.
✕. Has unresolved clinically significant toxicity of greater than or equal to NCI Institute Common Terminology Criteria for AEs (CTCAE v5.0) grade 2 attributed to any prior therapies (excluding anemia, lymphopenia, alopecia, skin pigmentation, and immune toxicities for MSI-H/dMMR ICI-refractory cohort as listed in cohort inclusion criteria).
✕. History of arterial thromboembolic event, venous thromboembolic event of grade 3 and above as specified in NCI CTCAE v5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 12 months prior to enrollment
✕. Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association \[NYHA\] classification . grade 2) or unstable vascular disease (eg, aortic aneurysm at risk of rupture, Moyamoya disease) that required hospitalization within 12 months prior to randomization, or other cardiac impairment that may affect the safety evaluation of the study drug (eg, poorly controlled arrhythmias, myocardial ischemia)
✕. Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks before enrollment

What they're measuring

1. Safety and Adverse Events (AEs)

Timeframe: Through study completion; an average of 1 year

Trial details

NCT IDNCT06959550

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-07-01

Contact for this trial

Saurav Haldar, MD

713-792-5111 GIClinicalTrials@mdanderson.org

View on ClinicalTrials.gov More Metastatic Colorectal Cancer trials