C101: Phase I study of GM102 in Gynaelogical Cancer

• Research type

  Research Study

• Full title

  Open, non-controlled, multi-centre, first-in-human study for the evaluation of the safety, pharmacokinetics and preliminary antitumor activity of GM102 in patients with advanced pretreated gynecological cancer

• IRAS ID

  230467

• Contact name

  Susana Banerjee

• Contact email

  Susana.Banerjee@rmh.nhs.uk

• Sponsor organisation

  Gamamabs Pharma

• Eudract number

  2015-004252-22

• Clinicaltrials.gov Identifier

  NCT02978755

• Duration of Study in the UK

  2 years, 5 months, 17 days

• Research summary

  The study consists in a part I (Dose Escalation) and a part Ib (Expansion cohorts); the site in UK will participate only to the part Ib of this study.
  The phase I part of this study is designed to determine the RP2D in monotherapy at different regimens (q2w or q1w) and in combination with chemotherapy using the classical 3+3 dose-finding design.
  The Phase Ib part of the study will evaluate the activity of GM102 in 45 patients, in three different cohorts (cohort 1: 15 to 25 patients with Sex Cord-Stromal tumours; cohort 2: 15 patients with AMHRII positive epithelial ovarian cancer; and cohort 3: maximum 5 patients with RMHII positive cervix cancer). Patients will be included from 10 hospitals in Belgium, France and UK.
  For each patient, the study visits will include
  1/ A screening period for inclusion.
  The AMHRII receptor on the tumour cells must be confirmed prior to participation in the study (except for patients with Sex Cord-Stromal tumors);
  2/ A treatment period defined by cycles of 4 weeks during which subjects will receive GM102 by intravenous route every 7 days or every two weeks, depending on the decision at the end of Phase I part; The patient will continue the study treatment until disease progression, unacceptable toxicity , death, withdrawal of consent, non-compliance to the protocol
  3/ A follow-up period of 60 days minimum after the last GM102 administration, including an End Of Treatment (EOT) visit 30 to 35 days after the last GM102 administration, and an End of Study (EOS) visit.
  Examinations or procedures to be performed during this study include Radiological scans; physical examinations; electrocardiograms (ECG), echocardiograms; fasting blood, urine samples; blood samples for pharmacokinetic assessment and possible repeat tumour biopsies may also be performed.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  18/LO/0006

• Date of REC Opinion

  16 Jan 2018

• REC opinion

  Favourable Opinion