A Phase 1 Study of CTIM-76 in Patients With Recurring Ovarian Cancer and Other Advanced Solid Tumors

Description

The phase 1a Dose Escalation portion of the trial will enroll subjects with platinum-resistant/refractory ovarian cancer (PRROC), testicular, or endometrial cancer into one of approximately 9 dose escalation cohorts to assess safety, tolerability and to determine the recommended dose for expansion (RDE). CTIM-76 is to be administered once weekly (Q1W) for each cycle. A cycle is defined as 28 days. Subjects will be dosed until documentation of disease progression, unacceptable toxicity, or subject/physician decision.

The phase 1b dose expansion phase will evaluate CTIM-76 in one indication (PRROC, endometrial or testicular) at up to 2 doses (n=15 response evaluable subjects at each dose level). This is to enable dose- and exposure-response analyses. Dosing will follow the same schedule as Phase 1a. A priming dose will be administered on Day 1, and the full cohort dose will be administered weekly thereafter. Expansion doses for Phase 1b will be determined by Sponsor in conjunction with Safety Review Committee (SRC) based upon all available safety, pharmacokinetic (PK), pharmacodynamic (PD), biomarker and preliminary efficacy data from Phase 1a.

The selection of the recommended Phase 2 dose (RP2D) will be based on the totality of data from Phase 1b.