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Monoclonal Antibody

Tepotinib for Colorectal Cancer

Phase 2
Waitlist Available
Research Sponsored by EMD Serono Research & Development Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at day 1 of cycle 1 (each cycle is of 21 days) and at end of treatment (14 days after last dose, assessed up to 210 days)
Awards & highlights

Summary

This trial tests a combination of two drugs, tepotinib and cetuximab, in patients with a specific type of colorectal cancer that no longer responds to usual treatments. Cetuximab is a type of antibody used in the treatment of colorectal cancer, often with other chemotherapy drugs. The drugs work together to block signals that help cancer cells grow. The goal is to see if this combination can stop or slow down the cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at day 1 of cycle 1 (each cycle is of 21 days) and at end of treatment (14 days after last dose, assessed up to 210 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 1 of cycle 1 (each cycle is of 21 days) and at end of treatment (14 days after last dose, assessed up to 210 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) According to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 5.0
Number of Participants With Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Investigators
Secondary study objectives
Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Investigator
Number of Participants With At Least 1 Postive Anti-Drug Antibodies (ADAs) for Cetuximab
Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Findings
+5 more

Side effects data

From 2018 Phase 1 & 2 trial • 66 Patients • NCT02115373
75%
Oedema peripheral
50%
Alanine aminotransferase increased
50%
Blood alkaline phosphatase increased
50%
Abdominal pain
50%
Constipation
50%
Vomiting
25%
Aspartate aminotransferase increased
25%
Blood bilirubin increased
25%
Eyelid oedema
25%
Post procedural infection
25%
Decreased appetite
25%
Dysphagia
25%
Fatigue
25%
Pyrexia
25%
Rib fracture
25%
Lumbar vertebral fracture
25%
Blood creatinine increased
25%
Amylase increased
25%
Gamma-glutamyltransferase increased
25%
Pain in extremity
25%
Flank pain
25%
Osteoporosis
25%
Dysgeusia
25%
Migraine with aura
25%
Renal impairment
25%
Peripheral venous disease
25%
Acute kidney injury
25%
Epistaxis
25%
Lipase increased
25%
Disease progression
25%
Dry mouth
25%
Nausea
25%
Eructation
25%
Nasopharyngitis
25%
Weight decreased
25%
Back pain
25%
Musculoskeletal chest pain
25%
Papule
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1b: Tepotinib 300 mg
Phase 2: Tepotinib 500 mg
Phase 1b: Tepotinib 500 mg

Trial Design

1Treatment groups
Experimental Treatment
Group I: Tepotinib + CetuximabExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tepotinib
2018
Completed Phase 2
~360
Cetuximab
2011
Completed Phase 3
~2480

Find a Location

Who is running the clinical trial?

EMD Serono Research & Development Institute, Inc.Lead Sponsor
82 Previous Clinical Trials
22,623 Total Patients Enrolled
Merck KGaA, Darmstadt, GermanyIndustry Sponsor
440 Previous Clinical Trials
114,571 Total Patients Enrolled
Medical ResponsibleStudy DirectorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
295 Previous Clinical Trials
60,977 Total Patients Enrolled
~1 spots leftby Sep 2025
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