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OPM-101 · 1 trial · 1 indication
In the phase 1b: the recommended dose for phase 2a will be based on the independent assessement of safety of OPM-101 by the DSMB
In phase 2a, Disease Control Rate defined as CR, PR or SD as per RECIST v.1.1 criteria
| Arm | Type | Description |
|---|---|---|
| OPM-101 (in combination with pembrolizumab) | EXPERIMENTAL | OPM-101 will be administered as hard gelatin capsules twice a day for 24 weeks. In the Phase 1b, 2 doses of OPM-101 will be considered: 75 mg bid and 150 mg bid. At the end of this Phase 1b, a recommended dose for Phase 2a will be determined. During the Phase 2a, the recommended dose of OPM-101 will be administered bid over 24 weeks. OPM-101 will be administered in combination with authorized regimen of Pembrolizumab. |
| Name | Type | Description |
|---|---|---|
| OPM-101 | DRUG | OPM-101 will be administered in combination with an authorized regimen of Pembrolizumab. Pembrolizumab will be administered by IV infusion either at a dose of 200 mg every 3 weeks or at a dose of 400 mg every 6 weeks, as per Principal Investigator's decision. |
Inclusion criteria 1. Written informed consent provided prior to any study-related procedure. 2. Histologically confirmed, unresectable or metastatic stage III or IV melanoma. 3. At least one measurable lesion per RECIST v.1.1 criteria. 4. Patients with a documented and confirmed Progressive Diseas...
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OPM-101 is an investigational small molecule being studied for the treatment of advanced melanoma, specifically in patients whose disease has shown resistance to anti-PD-1 therapy. It is being evaluated in combination with an anti-PD-1 agent in a Phase 1 clinical trial.
OPM-101 is a small molecule, but its specific molecular target has not been disclosed. The drug is being studied in combination with anti-PD-1 therapy for advanced melanoma, and the trial is biomarker-selected, meaning patients are chosen based on specific biological markers.
OPM-101 is being developed by Precision BioSciences, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol DTIL. The company is conducting a Phase 1 clinical trial of the drug in advanced melanoma.
OPM-101 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is assessing its safety and efficacy in combination with anti-PD-1 therapy for advanced melanoma.
OPM-101 is being evaluated in a single Phase 1 clinical trial with the identifier NCT07040436. This open-label, uncontrolled study is assessing the safety and efficacy of OPM-101 combined with anti-PD-1 in patients with advanced melanoma showing resistance to anti-PD-1. The trial is not yet recruiting and plans to enroll 41 participants.