Phase 1 Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Misetionamide (GP-2250) as Monotherapy or in Combination With Gemcitabine in Subjects With Advanced Solid Tumors
Persevere Therapeutics Inc.
Summary
This is a phase 1 dose escalation trial of monotherapy misetionamide (also known as GP-2250) currently enrolling patients with platinum-resistant ovarian cancer (PROC) into Part 2 of the study. Part 1 of the study evaluating misetionamide in combination with gemcitabine in subjects with advanced pancreatic cancer previously treated with 5-fluorouracil-based chemotherapy completed enrolment.
Description
Part 2 of the trial will use a 3+3 dose escalation design. Subjects will continue to receive treatment until disease progression assessed by RECIST V1.1 criteria, clinical disease progression as assessed by the Investigator, unacceptable toxicity, subject request for withdrawal or lost to follow-up, Investigator assessment that risk outweighs benefit or study closure by the Sponsor. Part 2 will study PROC patients with disease progression within 6 months of the last dose of platinum-based chemotherapy and maximum of 2 prior regimens with at least one regimen causing the patient to meet the def…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Abridged Inclusion Criteria: 1. Capable of giving signed informed consent: Regulatory, Ethical, and Trial Oversight Considerations which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 2. Subjects age \> 18 years at the time of trial entry. 3. Pathologically proven platinum-resistant epithelial ovarian, fallopian, or primary peritoneal cancer, with high-grade serous ovarian carcinoma (HGSOC) or a predominantly serous/endometroid component. Platinum-resistant disease, defined as disease progression within 6 months of la…