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Study for Evaluation of Murlentamab (GM102) Anti-tumoral Activity in Colorectal Cancers

NCT03799731 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2022-04-14

No results posted yet for this study

Summary

Phase 2A study, assessing the antitumor activity and the safety profile of GM102, a new compound (monoclonal antibody), administered alone or in combination with chemotherapy in patients with locally advanced or metastatic colorectal cancer. The primary objective of the study is to evaluate the antitumor activity of GM102 single agent and in combination with trifluridine/tipiracil.

Conditions

Interventions

DRUG

GM102

GM102 7 mg/kg weekly

DRUG

Trifluridine/Tipiracil

Lonsurf 35 mg/m² twice daily during 10 days per cycle

DRUG

GM102 expansion

GM102 7 mg/kg weekly after a loading dose of 10 mg/kg q1w during 28-day cycle 1

Sponsors & Collaborators

  • GamaMabs Pharma

    lead INDUSTRY

Principal Investigators

  • Eric Van Cutsem, MD · UZ Leuven, Belgium

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-11
Primary Completion
2021-01-19
Completion
2021-02-10

Countries

  • Belgium
  • Czechia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03799731 on ClinicalTrials.gov