NCT03854110
A Trial to Evaluate Safety, Tolerability, and Preliminary Efficacy of Misetionamide (GP-2250) as Monotherapy or in Combination With Gemcitabine
Recruiting · Phase 1 · Persevere Therapeutics Inc. · registry updated 2026-10-19
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- 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.
- Subjects age \> 18 years at the time of trial entry.
- 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 last dose of platinum-based chemotherapy.
- Maximum of 2 prior regimens for platinum-resistant disease. Subjects who are positive for high FR alpha (defined per the FDA approved companion diagnostic test (ELAHERE prescribing information) must have received MIRV. Candidates for MIRV with contraindications or documented intolerance are eligible pending documentation of discussion with the Medical Monitor.
- CT/MRI evidence of measurable disease per RECIST Version 1.1 defined as at least one lesion not previously irradiated that can be measured at baseline as 10 mm in the longest diameter (except lymph nodes which must have a short axis of 15 mm). Tumor lesions in previously irradiated area or in area subject to other loco-regional therapy are usually not considered measurable unless progression has been demonstrated in the lesion. Lesions selected as targets for response assessment should not be biopsied.
- ECOG performance status of 0-1
Exclusion
- Diagnosis of any active malignancy other than platinum-resistant ovarian cancer within the past 2 years (not including non-melanoma skin carcinoma, ductal carcinoma in situ of the breast, or carcinoma in situ of uterine cervix treated with curative intent).
- Subjects has a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonia or multiple allergies, clinically significant cardiovascular disease such as unstable angina, myocardial infarction, or acute coronary syndrome within \< 6 months prior to the start of study treatment, symptomatic or uncontrolled arrhythmia, congestive heart failure, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or ascites requiring paracentesis in the 4 weeks prior to Screening.
- Primary refractory disease (defined as failure to achieve at least a partial response (PR) to their initial platinum-based chemotherapy).
- Radiotherapy (RT) to target lesions, chemotherapy, or other systemic anti-cancer therapy, including prior anti-angiogenic treatment (e.g. bevacizumab) within 4 weeks prior to starting treatment.
- Ascites including history of therapeutic paracentesis within the 2 weeks prior to signing informed consent.
- Any other medical, psychiatric, or social condition deemed by the Investigator to be likely to interfere with a subject's rights, safety, welfare, or ability to sign informed consent, cooperate and participate in the trial, or which would interfere with the interpretation of the results.