Petosemtamab + Chemotherapy for Colon Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment, petosemtamab, combined with chemotherapy, to evaluate its effectiveness for individuals with colorectal cancer on the left side of the colon that is inoperable or has metastasized. Participants will receive either petosemtamab with chemotherapy or the standard treatment, cetuximab (a targeted therapy), with chemotherapy. The study aims to determine which combination better controls the cancer. It seeks participants with left-sided colorectal cancer who have not received other drugs for its advanced stages. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that petosemtamab is generally safe for people with advanced colorectal cancer. In earlier studies, most participants tolerated the treatment well, although some experienced manageable side effects. The safety profile of petosemtamab for colorectal cancer appears similar to its safety in treating other cancers, such as head and neck cancer.
For chemotherapy, mFOLFOX6 and FOLFIRI are common treatments for colorectal cancer, with well-documented safety. Patients might experience typical side effects like nausea or fatigue, but doctors can manage these effectively.
Overall, current evidence suggests that both petosemtamab and these chemotherapy options are safe for most patients.12345Why do researchers think this study treatment might be promising for colon cancer?
Researchers are excited about petosemtamab because it offers a fresh approach to treating colon cancer. Unlike standard treatments like cetuximab that target epidermal growth factor receptors (EGFR) to slow cancer growth, petosemtamab is designed to enhance the effectiveness of chemotherapy by potentially boosting the immune system's response against cancer cells. This unique mechanism could mean better outcomes for patients by making chemotherapy more effective than when used alone. Additionally, combining petosemtamab with established chemotherapy regimens like FOLFIRI or mFOLFOX6 might lead to improved survival rates and a new frontier in colon cancer treatment.
What evidence suggests that this trial's treatments could be effective for colon cancer?
Research has shown that petosemtamab holds promise in treating colorectal cancer. Previous studies reported that 62% of patients with left-sided colorectal cancer responded positively to the treatment, meaning more than half experienced beneficial effects. In this trial, participants will receive either petosemtamab combined with chemotherapy treatments like mFOLFOX6 or FOLFIRI, or cetuximab with the same chemotherapy options. Past studies have demonstrated that combining petosemtamab with these chemotherapy treatments improved results for many patients and was generally well-tolerated, causing no severe side effects for most people. These findings suggest that petosemtamab could be an effective option for treating colorectal cancer.12346
Who Is on the Research Team?
Study Official
Principal Investigator
Genmab
Are You a Good Fit for This Trial?
This trial is for adults with left-sided colon cancer that can't be removed by surgery or has spread, who have not had previous treatment for advanced disease. Their tumor must test negative for RAS and BRAF mutations using specific genetic tests, and they need to be healthy enough to receive standard chemotherapy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either petosemtamab + chemotherapy or cetuximab + chemotherapy. Treatment continues as long as the study is open and the participant's condition does not worsen.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cetuximab
- FOLFIRI
- mFOLFOX6
- Petosemtamab
Trial Overview
The study compares two treatments: petosemtamab plus chemotherapy (either mFOLFOX6 or FOLFIRI) versus cetuximab plus the same chemo options. Participants are randomly assigned to one of these groups. No placebo is used; everyone receives active treatment.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will receive petosemtamab and IC chemotherapy (mFOLFOX6 or FOLFIRI).
Participants will receive cetuximab + IC chemotherapy (mFOLFOX6 or FOLFIRI).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Genmab
Lead Sponsor
Dr. Jan van de Winkel
Genmab
Chief Executive Officer since 2010
PhD in Immunology, University of Utrecht
Dr. Judith Klimovsky
Genmab
Chief Medical Officer since 2019
MD, University of Copenhagen
Citations
1.
aacrjournals.org
aacrjournals.org/mct/article/24/10_Supplement/B033/766559/Abstract-B033-Petosemtamab-MCLA-158-monotherapy-orAbstract B033: Petosemtamab (MCLA-158) monotherapy or ...
Petosemtamab demonstrates promising efficacy and manageable safety across 1L, 2L and 3L+ mCRC. Updated data will be provided; biomarker analysis ...
Petosemtamab, a Bispecific Antibody Targeting Epidermal ...
petosemtamab monotherapy demonstrated a 36% confirmed overall response rate (ORR) in 75 evaluable patients, with median overall survival (mOS) ...
3.
onclive.com
onclive.com/view/frontline-petosemtamab-doublet-elicits-responses-in-recurrent-metastatic-hnsccFrontline Petosemtamab Doublet Elicits Responses in ...
The combination therapy achieved a 67% ORR, a median overall survival of 11.5 months (95% CI, 7.2-20.6) in patients with HNSCC.
A Phase 1-2 Study of Petosemtamab Alone or With ...
Petosemtamab is a bispecific antibody. It works against cancer by binding to two proteins. One protein is on cancer cells. may help cancer cells survive ...
Merus' Interim Data on Petosemtamab in Metastatic ...
100% response rate in 1L left-sided mCRC (n=8, confirmed and unconfirmed) – 62% response rate in 2L left- and right-sided mCRC (n=13, confirmed ...
6.
quiverquant.com
quiverquant.com/news/Merus+N.V.+Updates+on+Petosemtamab+Clinical+Trials+in+Head+and+Neck+Squamous+Cell+Carcinoma+and+Metastatic+Colorectal+CancerMerus N.V. Updates on Petosemtamab Clinical Trials in ...
Significant clinical outcomes observed, including an overall response rate of 36% in patients treated with petosemtamab, indicating its
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