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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02978755
• Date of registration: 23/11/2016
• Prospective Registration: No
• Primary sponsor: GamaMabs Pharma
• Public title: First In Human Safety, Pharmacokinetics and Anti-tumoral Activity of GM102 in Gynecological Cancers
• Scientific title: Open, Non Controlled, Multicenter, Firs-in-human Study for the Evaluation of the Safety, Pharmacokinetics and Preliminary Antitumor Activity of GM102 in Patients With Advanced Pretreated Gynecological Cancer
• Date of first enrolment: June 2016
• Target sample size: 78
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02978755
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Belgium, France, United Kingdom

Contacts

• Name: Alexandra Leary, MD/PhD
• Affiliation: Gustave Roussy center, Villejuif, France

Key inclusion & exclusion criteria

Inclusion Criteria:

- Locally advanced, or metastatic recurrent gynecological cancer, for whom no standard
alternative therapy is available, having received at least one line of therapy and
expressing AMHRII on tumor cells.

- If possible at least one lesion should be identified for 2 biopsies: a baseline biopsy
and an under-treatment biopsy for AMHRII expression and GM102 pharmacodynamics
evaluation.

- Available tumor block or at least 10 slides from formalin-fixed paraffin-embedded
(FFPE) archival tissue.

- At least one measurable lesion by RECIST (Response Evaluation Criteria in Solid
Tumors) on screening CT-scan.

- Written Informed Consent forms.

- Willing and able to comply with the trial requirements.

- Covered by healthcare insurance in accordance with local requirements.

For phase 1b, only patients with either Sex cord stromal tumors or epithelial ovarian
cancer or cervix cancer will be eligible

Exclusion Criteria:

- Age < 18 years old.

- Eastern Cooperative Oncology Group (ECOG) performance status > 1

- Life expectancy < 12 weeks.

- Known or symptomatic brain metastasis (other than totally resected or previously
irradiated and non-progressive/relapsing) or lepto-meningeal carcinomatosis.

- Concurrent treatment with any other anticancer therapy.

- Concurrent chronic corticosteroid treatment.

- Known severe anaphylactic or other hypersensitivity reactions secondary to a prior
exposure to human antibodies or to any protein product.

- Washout period before treatment initiation: < 3 weeks or 5 times the half-life,
whichever is shorter, for prior antitumor therapy (small molecules and/or
antibody-drug conjugates, radiotherapy) or 6 weeks for monoclonal antibodies.

- Any active concomitant malignancy.

- Serious concomitant illness e.g. active infection requiring systemic antibiotic,
antifungal or antiviral drug, or physical examination or laboratory abnormalities,
that, in the opinion of the Investigator, would compromise protocol objectives.

- Poor bone marrow reserve as defined by neutrophils < 1.0 x 10E9/L or haemoglobin < 9.0
g/dL or platelet count < 100 x 10E9/L.

- Poor organ function as defined by any one of the following: left ventricular ejection
fraction = 40%, serum creatinine > 1.5 x upper limit of normal (ULN), total bilirubin
> 1.5 x ULN, AST and ALT> 2.5 x ULN in the absence of liver metastasis or > 5 x ULN in
case of documented liver metastasis.

- Non-resolution of any prior treatment related toxicity to < Grade 2, except for
alopecia according to National Cancer Institute-Common Terminology Criteria for
Adverse Events (NCI-CTCAE) v4.03.

- Pregnancy or breastfeeding.

- Patient with reproductive potential who do not agree to use an accepted effective
method of contraception - investigator's judgment - during the study period and for at
least 4 months following completion of study treatment.

- Patient participating in another clinical trial investigating a treatment during the
study and within 30 days prior to first study treatment administration.

- Patient deprived of her liberty by a judicial or administrative decision, patient
admitted to a hospital, social institution or who is under a measure of legal
protection, patient hospitalized without consent or who is in an emergency situation.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Neoplasm, Gynecologic

Intervention(s)

Drug: GM102

Drug: Paclitaxel + carboplatin

Primary Outcome(s)

Phase I part: incidence of Dose Limiting Toxicities (DLTs) [Time Frame: Four weeks]

Phase Ib part: incidence of Serious Adverse Events (SAEs) and Treatment-Emergent Adverse Events (TEAEs) at Recommended Phase 2 Dose (RP2D) [Time Frame: Through study completion, an average of 1 year]

Secondary Outcome(s)

Response Rate using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 [Time Frame: Through study completion, an average of 1 year]

Maximum Serum Concentration [Cmax] [Time Frame: up to 16 weeks]

Area Under the Curve [AUC] [Time Frame: up to 16 weeks]

Clinical benefit rate defined as percentage of patients achieving Complete Response (CR), Partial Response (PR) or Stable Disease (SD) superior to 3 months [Time Frame: up to 3 months]

Secondary ID(s)

C101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors