960 Participants NeededMy employer runs this trial

Petosemtamab + Chemotherapy for Colon Cancer

Recruiting at 5 trial locations
GT
Overseen ByGenmab Trial Information
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

Why 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?

SO

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

I am eligible to receive mFOLFOX6 or FOLFIRI chemotherapy.
I have not had any systemic treatment for advanced or metastatic colorectal cancer.
I have left-sided colorectal cancer that cannot be removed or has spread.
See 1 more

Exclusion Criteria

I have previously received drugs that target the EGFR protein.
I have a complete deficiency in the DPD enzyme.
I have a genetic test showing specific UGT1A1 gene changes (*28 or *6 alleles).
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

Variable (4-week cycles)
2 visits per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Variable

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

Group I: Petosemtamab + IC ChemotherapyExperimental Treatment3 Interventions
Group II: Cetuximab + IC ChemotherapyActive Control3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Genmab

Lead Sponsor

Trials
76
Recruited
15,300+

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

Abstract 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) ...

Frontline 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 ...

Merus 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