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

• Status: Recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Part 1 (Phase IA single agent portion) will test the tolerability of continuous twice a day dosing of 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 side effects and DLTs.

Part 2 (Phase IB combination therapy portion) will test the tolerability of continuous 28-day cycles of GRN-300 in combination with weekly paclitaxel x 3.

Overall duration of the study will be approximately 24 months, depending on the rate of enrollment and number of subjects enrolled.

Overall duration of the study will be approximately 24 months, depending on the rate of enrollment and number of subjects enrolled.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Green3Bio, Inc.
• Treatments: Paclitaxel

Criteria

Inclusion Criteria:

• Age ≥ 18 years.

• Diagnosis of recurrent ovarian, primary peritoneal or fallopian tube epithelial cancer, or metastatic solid tumors. Histologic or cytologic confirmation of the original tumor by MD Anderson Cancer Center Pathology is required.

• Patients must have measurable disease defined as at least one lesion that can be accurately measured in at least one dimension as defined by RECIST 1.1.

• Prior therapy: Patients must have received at least one prior second-line treatment for persistent / recurrent disease but may have received any number of prior treatments.

• ECOG score of 0-1.

• Adequate bone marrow, liver and renal function.

Exclusion Criteria:

• Patients who have undergone major surgery ≤ 4 weeks prior to starting study drug.

• Patients with known hypersensitivity to paclitaxel or residual Grade 2 or higher neuropathy (excluded from Phase IB portion only).

• Use of any cytotoxic chemotherapy or investigational drugs, biologics, or devices within 21 days prior to study enrollment.

• Women who are pregnant or breastfeeding.

• Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy.

• Known CNS metastases or leptomeningeal disease.

• Gastrointestinal dysfunction that may affect oral drug absorption (e.g., intermittent or chronic bowel obstruction, short gut, etc.).

• Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism within six months of start of study treatment.

• Other medical co-morbidities that in the investigator's judgment would increase the risks of participation

• QTc >480 msec be excluded from the study