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First In Human Safety, Pharmacokinetics and Anti-tumoral Activity of GM102 in Gynecological Cancers

NCT02978755 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2022-04-06

No results posted yet for this study

Summary

First in Human study, assessing the safety profile, the pharmacokinetics and preliminary antitumor activity of GM102, a new compound (a monoclonal antibody), in patients with previously treated gynecological cancers bearing the AMHRII (anti-mullerian Hormone Receptor II) receptor. The primary objective of the study is to determine the GM102 recommended dose.

Conditions

  • Neoplasm, Gynecologic

Interventions

DRUG

GM102

GM102 escalating doses (phase1)

DRUG

GM102 escalating doses

GM102 escalating doses combined with paclitaxel and carboplatin

DRUG

GM102

GM102 single agent at recommended dose in 3 parallel cohorts (sex cord, epithelial ovarian, cervix cancers)

Sponsors & Collaborators

  • GamaMabs Pharma

    lead INDUSTRY

Principal Investigators

  • Alexandra Leary, MD/PhD · Gustave Roussy center, Villejuif, France

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2020-06-10
Completion
2020-06-10

Countries

  • Belgium
  • France
  • United Kingdom

Study Locations

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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 NCT02978755 on ClinicalTrials.gov