Finding studies
Finding studies
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Lead
Centre Leon Berard
This trial is a multicenter, single arm, open-label Phase I/II trial that include: * A centralised biological pre-screening to only select patients with FGFR2b overexpressing tumors. * First part : a dose escalation part to define the RP2D of bemarituzumab in combination with fixed dose of bevacizumab (12 to 18 patients independently of tumor types). Eligible patients will be treated with a escalating doses of bemarituzumab : 15 mg/kg cycle 1 day 1, then 11 mg/kg thereafter from cycle 2 day 1; 22 mg/kg cycle 1 day 1, then 15 mg/kg thereafter from cycle 2 day 1; 30 mg/kg cycle 1 day 1, then 22 mg/kg thereafter from cycle 2 day 1; and fixed dose of bevacizumab (15 mg/kg, IV infusion, every 3 weeks). To ensure adequate patient safety during the dose escalation part, there will be a 3-day delay between the first and subsequent patients enrolled in each DL cohort to maximize the safety of enrolled patients. \- Second part : an extension part to assess the clinical activity of the combination in 3 independent and parallel cohort (ovarian, endometrial or cervix carcinoma) (up 25 patients in total per cohort).The Phase II part will use a Simon's min-max two-stage design. Eligible patients will be treated by bemarituzumab (at RP2D defined in the phase I dose escalation, IV, every 3 weeks) and bevacizumab (15 mg/kg, IV, every 3 weeks).
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
