Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors.
Status:
Recruiting
Trial end date:
2024-01-28
Target enrollment:
Participant gender:
Summary
The purpose of this study is to assess the safety, tolerability and preliminary efficacy of
CYH33 in combination with olaprib in patients with DDR gene mutations and/or PIK3CA
mutations, in patients who have progressed on prior PARP inhibitor, and in patients with
recurrent high grade serous ovarian, fallopian tube, or primary peritoneal cancer who are
platinum resistant or refractory. The study will assess if this combination will optimize
anti-tumor activity, block tumor growth and overcome the resistance to PARP inhibitor
treatment. The study consists 2 parts. In Part 1 dose escalation, the objective is to
determine the maximum toleration dose (MTD) of the combination. The final recommended phase 2
dose (RP2D) of CYH33 in combination with olaparib will be based on the totality of an overall
assessment of available safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD),
and preliminary efficacy which could be the MTD or a dose level lower in specific cohorts of
patients. In Part 2 dose expansion, the main objective is to evaluate the efficacy at RP2D.