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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Ivonescimab

    Drug

    Given by IV

Treatment groups

90 Participants
are divided into 1 treatment group
Group A: Treatment with IvonescimabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

1. Safety and Adverse Events (AEs)

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Time frame
Through study completion; an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

Akesobio Australia Pty Ltd

Collaborator

Summit Therapeutics

Collaborator