Ivonescimab and ADG126 for Colorectal Cancer

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the safest and most effective dose of a new treatment combination for advanced or metastatic colorectal cancer that is microsatellite stable (MSS). The study will test different combinations of the investigational drugs ADG126 and ivonescimab, with some groups also receiving additional chemotherapy drugs. This research focuses on harnessing the immune system and stopping tumor growth by targeting cancer cells and blocking new blood vessel formation. People diagnosed with MSS colorectal cancer that has spread and who have previously undergone certain cancer treatments may be a good fit for this study. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does prohibit certain treatments like chemotherapy, radiation, and some other anti-cancer therapies within a specific time before starting the trial. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research suggests that using ivonescimab and ADG126 together might be safe for treating colorectal cancer. Studies are examining patient tolerance to these treatments, aiming to find the best dose with the fewest side effects. These treatments can be administered alone or with other drugs like leucovorin, fluorouracil, and irinotecan, which are commonly used in cancer care.

As the studies are in the early stages, researchers are primarily focusing on safety. This phase helps determine treatment tolerance and potential side effects. Since these are early trials, much remains to be learned about the risks and benefits. However, ongoing research indicates that the treatment could be well-tolerated by patients.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatments in this trial for colorectal cancer because they explore new combinations that could enhance effectiveness. Unlike standard treatments like FOLFOX or CAPOX, which rely on specific chemotherapy regimens, these investigational treatments include ivonescimab, a novel antibody that targets specific pathways involved in tumor growth. Combined with other drugs like muzastotug, leucovorin, fluorouracil, and sometimes irinotecan, these combinations aim to improve outcomes by potentially increasing the body's immune response against cancer cells. This innovative approach may lead to more effective and personalized treatment options for patients.

What evidence suggests that this trial's treatments could be effective for colorectal cancer?

Research shows that combining ADG126 and ivonescimab may help treat microsatellite stable (MSS) colorectal cancer. ADG126 is a special protein that activates in the tumor area to help the immune system fight the cancer. Studies have found that patients with MSS colorectal cancer typically respond for 8 months and have an average overall survival time of 19.4 months. Ivonescimab aids by stopping the growth of blood vessels that tumors need to survive. In this trial, some participants will receive ivonescimab with chemotherapy drugs, such as those in the FOLFIRI regimen, to enhance effectiveness and possibly improve patient outcomes.16789

Who Is on the Research Team?

MG

Marwan G Fakih

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced or metastatic microsatellite stable colorectal cancer, confirmed by a certified test. Participants must have an ECOG performance status of ≤1, measurable disease, and recovered from previous cancer therapies. Specific arms require progression after certain treatments or eligibility for maintenance therapy.

Inclusion Criteria

I am eligible for maintenance chemotherapy with 5-FU/LV or 5-FU/LV plus bevacizumab.
I have recovered from serious side effects of cancer treatment, except for hair loss.
I have given my consent or my legal representative has.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive muzastotug and ivonescimab, with or without leucovorin, fluorouracil, and irinotecan, in cycles every 6 weeks for up to 24 months

24 months
Visits on days 1, 15, and 29 of each 6-week cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

2 years
Every 3 months until disease progression, then periodically for survival

What Are the Treatments Tested in This Trial?

Interventions

  • ADG126
  • Fluorouracil
  • Irinotecan
  • Ivonescimab

Trial Overview

The trial tests ADG126 and ivonescimab alone or combined with leucovorin and fluorouracil (FOLFIRI regimen) in treating advanced/metastatic colorectal cancer. It explores the safety, side effects, and optimal dosages of these immunotherapies that may inhibit tumor growth and spread.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Arm C (muzastotug, ivonescimab, FOLFIRI)Experimental Treatment8 Interventions
Group II: Arm B (muzastotug, ivonescimab, leucovorin, fluorouracil)Experimental Treatment7 Interventions
Group III: Arm A (muzastotug, ivonescimab)Experimental Treatment5 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials
614
Recruited
1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Citations

Study Details | NCT07363408 | Ivonescimab and ADG126, ...

It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Giving ADG126 with ivonescimab, with or without ...

Safety and efficacy of ADG126 (an anti-CTLA-4 masking ...

ADG126 is an anti-CTLA-4 IgG1 masked antibody that is preferentially activated in the tumor upon cleavage of masking peptides in the tumor microenvironment.

ADG126 Exhibits Clinical Meaningful Efficacy in MSS CRC

Patients demonstrated a median duration of response (DOR) of 8 months, and an interim median overall survival (OS) of 19.4 months after 18 ...

Adagene Presents Results at ESMO Congress that Show Best ...

Confirmed partial responses (PRs) doubled to four since ASCO GI in MSS CRC patients without liver and peritoneal metastases for overall response rate (ORR) ...

News Details

Summit Therapeutics Announces Expansion of Ivonescimab Global Phase III Development Program with HARMONi-GI3 Study in 1L Colorectal Cancer.

Ivonescimab and ADG126, Alone and in Combination with ...

Study AimThis study aims to evaluate the safety and effectiveness of Ivonescimab and ADG126, both used alone and in combination with 5-FU/LV ...

Ivonescimab and ADG126 for Colorectal Cancer

This phase I trial studies the safety, side effects, and best dose of ADG126, in combination with ivonescimab alone, in combination with ...

Ivonescimab and ADG126, Alone, and in Combination With ...

Giving ADG126 with ivonescimab, with or without leucovorin and fluorouracil or FOLFIRI regimen, may be safe in treating patients with MSS ...

A Phase I Clinical Trial of Ivonescimab and ADG126, Alone ...

This phase I trial studies the safety, side effects, and best dose of ADG126, in combination with ivonescimab alone, in combination with ...