90 Participants Needed

Ivonescimab for Colorectal Cancer

SH
Overseen BySaurav Haldar, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: M.D. Anderson Cancer Center
Must be taking: PD-1/PD-L1 inhibitors
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that systemic anti-cancer treatment should not be taken within 14 days before starting the study treatment. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug Ivonescimab for colorectal cancer?

While there is no direct data on Ivonescimab for colorectal cancer, similar treatments like cetuximab, when combined with chemotherapy, have shown effectiveness in improving response rates and survival in patients with metastatic colorectal cancer.12345

How is the drug Ivonescimab different from other treatments for colorectal cancer?

Ivonescimab is unique because it may target specific pathways involved in cancer growth, similar to other monoclonal antibodies like bevacizumab and cetuximab, which target blood vessel growth and epidermal growth factor receptors, respectively. This approach can potentially offer a new mechanism of action compared to traditional chemotherapy options.56789

Research Team

SH

Saurav Haldar, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

Adults over 18 with metastatic colorectal cancer that has worsened after treatment, including anti-PD-1/PD-L1 therapy. Participants must have measurable disease, a life expectancy over 3 months, and be able to provide recent tumor tissue. They should not have severe allergies or conditions that could affect study participation.

Inclusion Criteria

My cancer is an advanced type that started in my colon or rectum.
My cancer progressed after treatment with specific immune therapies.
My cancer's MMR or MSI status is known through tests like IHC, PCR, or sequencing.
See 20 more

Exclusion Criteria

My tumor is affecting nearby major organs or blood vessels.
I have not had cancer treatment within the specified time.
I have not had a severe COPD flare-up in the last 4 weeks.
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ivonescimab to evaluate its efficacy and safety in metastatic colorectal cancer

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Ivonescimab
Trial OverviewThe trial is testing Ivonescimab's effectiveness in controlling metastatic colorectal cancer after previous treatments failed. It involves patients who've progressed on immune checkpoint inhibitors and requires them to have specific genetic markers of their tumors tested.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment with IvonescimabExperimental Treatment1 Intervention
Participants will be assigned to the study using a Bayesian Optimal Phase 2 (BOP2) design

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Akesobio Australia Pty Ltd

Industry Sponsor

Trials
10
Recruited
690+

Summit Therapeutics Sub, Inc

Collaborator

Trials
1
Recruited
50+

Findings from Research

In a phase II trial involving 82 patients with advanced colorectal cancer, the combination of cetuximab and FOLFOX6 showed an overall response rate of 44.8%, indicating its efficacy as a first-line treatment.
Patients who developed skin toxicity while on the treatment had significantly longer median survival times (21.7 months) compared to those who did not experience this side effect, suggesting a potential correlation between skin reactions and treatment effectiveness.
A phase II trial of FOLFOX6 and cetuximab in the first-line treatment of patients with metastatic colorectal cancer.Boccia, RV., Cosgriff, TM., Headley, DL., et al.[2016]
In a phase II study involving 99 patients with wild-type KRAS colorectal cancer, the biweekly combination of cetuximab and FOLFOX-4 achieved an overall response rate (ORR) of 60.6%, indicating significant efficacy as a first-line treatment.
The safety profile was consistent with previous studies, with common grade 3-4 toxicities including neutropenia (32.3%) and acne-like rash (15.2%), suggesting that the biweekly regimen is both effective and manageable for patients.
Biweekly cetuximab in combination with FOLFOX-4 in the first-line treatment of wild-type KRAS metastatic colorectal cancer: final results of a phase II, open-label, clinical trial (OPTIMIX-ACROSS Study).Fernandez-Plana, J., Pericay, C., Quintero, G., et al.[2023]
Cetuximab combined with chemotherapy shows a good overall response rate (43.1%) and overall survival (28.5 months) in patients with advanced colorectal cancer and unclear K-ras status, based on a study of 102 patients.
The treatment is considered safe, with common side effects including acneiform eruptions and neutropenia, but no treatment-related deaths were reported, indicating a favorable safety profile.
[Efficacy of cetuximab combined with chemotherapy for patients with advanced colorectal cancer and unclear K-ras status].Guo, GF., Xia, LP., Qiu, HJ., et al.[2018]

References

A phase II trial of FOLFOX6 and cetuximab in the first-line treatment of patients with metastatic colorectal cancer. [2016]
Fluorouracil, leucovorin, and oxaliplatin with and without cetuximab in the first-line treatment of metastatic colorectal cancer. [2022]
Biweekly cetuximab in combination with FOLFOX-4 in the first-line treatment of wild-type KRAS metastatic colorectal cancer: final results of a phase II, open-label, clinical trial (OPTIMIX-ACROSS Study). [2023]
[Efficacy of cetuximab combined with chemotherapy for patients with advanced colorectal cancer and unclear K-ras status]. [2018]
Targeting metastatic colorectal cancer in 2008: a long way from 5-FU. [2018]
Systemic therapy for advanced or metastatic colorectal cancer: National Comprehensive Cancer Network guidelines for combining anti-vascular endothelial growth factor and anti-epidermal growth factor receptor monoclonal antibodies with chemotherapy. [2018]
Antibody-based therapies for colorectal cancer. [2018]
Targeted therapies in the management of colorectal carcinoma: role of bevacizumab. [2021]
New drugs in the treatment of colorectal carcinoma. [2019]