First-in-Human Evaluation of GRN-300 in Subjects With Recurrent Ovarian, Primary Peritoneal, and Fallopian Tube Cancers.

Summary

The study consists of two parts based on the administration of single-agent GRN-300 or in combination with paclitaxel. Part 1 (Phase IA) will test the tolerability of continuous twice a day dosing of oral GRN-300, a salt-inducible kinase inhibitor, with each cycle consisting of 28 days of treatment. The number of administered cycles will depend on the tolerability of each dose level and the severity and occurrence of dose limiting toxicities (DLTs) or adverse events. Part 2 (Phase IB) will test the tolerability of continuous 28-day cycles of GRN-300 in combination with weekly paclitaxel given 3 of 4 weeks per month (x 3). Overall duration of the study will be approximately 48 months, depending on the rate of enrollment and number of subjects enrolled.

Timeline

Start

2020-12-21

Primary completion

2024-12

Completion

2025-03

Outcome

Outcome not reported

Stopped (Business): “Business/Commercial Reasons”

Drugs

Indications