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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

Study Summary

This study is evaluating whether a combination of two drugs may help treat colorectal cancer.

Timeline

Screening ~ 3 weeks3 visits

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)

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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%

Blood bilirubin increased

25%

Dysgeusia

25%

Osteoporosis

25%

Migraine with aura

25%

Lumbar vertebral fracture

25%

Rib fracture

25%

Aspartate aminotransferase increased

25%

Blood creatinine increased

25%

Dysphagia

25%

Eyelid oedema

25%

Amylase increased

25%

Pyrexia

25%

Post procedural infection

25%

Decreased appetite

25%

Fatigue

25%

Gamma-glutamyltransferase increased

25%

Peripheral venous disease

25%

Pain in extremity

25%

Renal impairment

25%

Flank pain

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%

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

EMD Serono Research & Development Institute, Inc.Lead Sponsor

76 Previous Clinical Trials

30,857 Total Patients Enrolled

Merck KGaA, Darmstadt, GermanyIndustry Sponsor

436 Previous Clinical Trials

114,653 Total Patients Enrolled

Medical ResponsibleStudy DirectorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

288 Previous Clinical Trials

68,972 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Recent research and studies

clinicaltrials.govStudy

Study of Tepotinib Combined With Cetuximab in Participants With Left-Sided RAS/BRAF Wild Type Metastatic Colorectal Cancer (PERSPECTIVE)

2021. "Study of Tepotinib Combined With Cetuximab in Participants With Left-Sided RAS/BRAF Wild Type Metastatic Colorectal Cancer (PERSPECTIVE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04515394.

~1 spots leftby Apr 2025

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