Clinical trial · Interventional
First-in-Human Evaluation of GRN-300 in Subjects With Recurrent Ovarian, Primary Peritoneal, and Fallopian Tube Cancers.
Ph 1/1B Evaluation of the Safety, Pharmacokinetics and Efficacy of GRN-300, a Salt-inducible Kinase Inhibitor, Alone and in Combination With Paclitaxel, in Recurrent Ovarian, Primary Peritoneal, and Fallopian Tube Cancers.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business/Commercial Reasons
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Tumors | Ovarian Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GRN-300 | Drug | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part 1 (Phase 1a): Single Arm, Open Label (GRN-300 single-agent)
- description
- Part 1 of the study will determine the safety of continuous twice a day oral dosing of GRN-300, 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. The maximal tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of GRN-300 as a single agent will be determined. The overall duration of Part 1 will be approximately 24-36 months, depending on the rate of enrollment and the number of subjects enrolled.
- interventionNames
- Drug: GRN-300
- type
- EXPERIMENTAL
- label
- Part 2 (Phase 1b): Single Arm, Open Label (GRN-300 plus paclitaxel)
- description
- The study will determine the safety of continuous twice a day oral dosing of GRN-300, with each cycle consisting of 28 days of treatment, in combination with intravenously administered paclitaxel weekly x 3 during each 28-day cycle. The number of administered cycles will depend on the tolerability of each dose level and the severity and occurrence of side effects and DLTs. The maximal tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of GRN-300 in combination with paclitaxel will be determined. The overall duration of Part 2 will be approximately 12-18 months, depending on the rate of enrollment and the number of subjects enrolled. Part 2 will commence following determination of the MTD and RP2D of single-agent GRN-300 in Part 1. Overall duration of the study will be approximately 36-48 months, depending on the rate of enrollment and number of subjects enrolled.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years. * Part 1 dose-escalation cohorts: Diagnosis of persistent or recurrent, locally non-resectable or metastatic ovarian, primary peritoneal or fallopian tube epithelial cancer, or advanced solid tumors of any other histology who have progressed on standard therapy and for whom no further effective therapy is available * Part 1 dose-expansion cohort / Part 2 dose-escalation cohorts / Part 2 dose-expansion cohort: Diagnosis of persistent or recurrent, locally non-resectable or metastatic ovarian, primary peritoneal or fallopian tube epithelial cancer who have progressed on standard therapy and for whom no further effective therapy is available. Patients with advanced solid tumors of any other histology will not be eligible to be enrolled in these cohorts. * Part 2 dose-escalation cohorts / Part 2 dose-expansion cohort: paclitaxel treatment for the tumor should be indicated * Histologic or cytologic confirmation of the original tumor by Pathology assessment 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, locally non-resectable or metastatic disease but may have received any number of prior treatments. * Any unresolved toxicities from prior therapy should be no greater than NCI-CTCAE v5.0 Grade 1 at screening. * Patients who are expected to survive a minimum of three months after the first administration of the study drug. * Eastern Cooperative Oncology Group performance status (ECOG PS) 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 excluded from Part 2 paclitaxel combination 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
References
Publications (0)
Data not yet available