Recruiting soon

Ivonescimab and ADG126, Alone and in Combination with 5-FU/LV or FOLFIRI for MSS Advanced/Metastatic Colorectal Cancer

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study Aim

This study aims to evaluate the safety and effectiveness of Ivonescimab and ADG126, both used alone and in combination with 5-FU/LV or FOLFIRI, in treating individuals with advanced or metastatic colorectal cancer that is microsatellite stable (MSS).

What is being tested

Biospecimen Collection

+ Computed Tomography

+ Ivonescimab

ProcedureBiologicalDrug
Who is being recruted

Colonic Diseases+8

+ Digestive System Diseases

+ Digestive System Neoplasms

Over 18 Years
+57 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: July 2026
See protocol details

Summary

Principal SponsorCity of Hope Medical Center
Last updated: January 24, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 21, 2026

Actual date on which the first participant was enrolled.

This clinical trial focuses on treating advanced or metastatic colorectal cancer that has not spread to the liver, a condition also known as MSS colorectal cancer. The study aims to find the optimal dosage for two drugs, muzastotug (ADG126) and ivonescimab, either used alone or in combination with other treatments like fluorouracil (5-FU)/leucovorin (LV) or FOLFIRI. The importance of this study lies in its potential to improve treatment options for this specific type of colorectal cancer. Participants in this trial will be assigned to one of three groups. In each group, they will receive muzastotug through an IV drip and ivonescimab through an IV infusion at different intervals. Depending on the group, they may also receive additional treatments like leucovorin, fluorouracil, and irinotecan. These treatments will be given in cycles lasting six weeks, for up to two years unless the disease progresses or there are unacceptable side effects. Throughout the study, participants will undergo CT or MRI scans and provide blood samples to monitor their health and the effectiveness of the treatment. The study will also look at the safety of these treatments and how they affect the immune system.

Official TitleA Phase I Clinical Trial of Ivonescimab and ADG126, Alone, and in Combination With 5-FU/LV or FOLFIRI in MSS Advanced/Metastatic Colorectal Cancer 
NCT07363408
Principal SponsorCity of Hope Medical Center
Last updated: January 24, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Colonic DiseasesDigestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsNeoplasmsNeoplasms by SiteRectal DiseasesColorectal Neoplasms

Criteria

26 inclusion criteria required to participate
Patients should not have evidence of hepatic metastatic disease
Patients should have progressed following irinotecan, oxaliplatin, fluoropyrimidine, and an anti-EGFR if clinically indicated
Patient is eligible for maintenance 5-FU/LV or 5-FU/LV bevacizumab
No history of significant toxicity to 5-FU/LV that required dose reduction in infusional 5-FU dosing
Show More Criteria
31 exclusion criteria prevent from participating
Major surgical procedures or serious trauma within 4 weeks prior to study entry, 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 study entry
Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
Chemotherapy, radiation therapy, biological therapy, immunotherapy within 21 days or five half-lives (whichever is shorter for non-radiation therapy) prior to day 1 of protocol therapy
Any other anti-cancer therapy is prohibited, including but not limited to antibody-based therapy, retinoids, nitrosourea therapy, mitomycin C, small molecule tyrosine kinase inhibitors, proprietary Chinese medicines with anti-cancer activity, or radiotherapy
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients receive muzastotug IV over 60-90 minutes on day 1 of each cycle and ivonescimab IV over 60 minutes on days 1, 15, and 29 of each cycle. Cycles repeat every 6 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI, and collection of blood samples throughout the study.

Group II

Experimental
Patients receive muzastotug IV over 60-90 minutes on day 1 of each cycle, ivonescimab IV over 60 minutes on days 1, 15, and 29 of each cycle, leucovorin IV over 2 hours on days 1, 15, and 29 of each cycle, and fluorouracil IV continuously over 46 hours on days 1, 15, and 29 of each cycle. Cycles repeat every 6 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI, and collection of blood samples throughout the study.

Group III

Experimental
Patients receive muzastotug IV over 60-90 minutes on day 1 of each cycle, ivonescimab IV over 60 minutes on days 1, 15, and 29 of each cycle, leucovorin IV over 2 hours on days 1, 15, and 29 of each cycle, fluorouracil IV continuously over 46 hours on days 1, 15, and 29 of each cycle, and irinotecan IV over 90 minutes on day 1 of each cycle. Cycles repeat every 6 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI, and collection of blood samples throughout the study.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

City of Hope Medical Center

Duarte, United StatesSee the location
Recruiting soonOne Study Center