Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
OP-1250 · 1 trial · 2 indications
Number of Participants with Dose Limiting Toxicities (DLT) during Dose Escalation Only
Characterize the incidence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of OP-1250 in patients that had at least one treatment emergent adverse event according to NCI-CTCAE version 5.0.
Plasma concentrations of OP-1250 assessed steady state
Tumor response will be evaluated in patients with measurable or evaluable disease, using RECISTv1.1 guidelines (Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR)). Overall response rate which includes confirmed Partial Response (cPR).
| Arm | Type | Description |
|---|---|---|
| OP-1250 Phase I Part A (Dose Escalation) | EXPERIMENTAL | Phase I Part A will evaluate the safety and pharmacokinetics (PK)of a range of OP-1250 doses to identify the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D). |
| OP-1250 Phase I Part B (Dose Expansion) | EXPERIMENTAL | Phase I Part B will evaluate the safety and PK of OP-1250 to confirm the RP2D dose. |
| OP-1250 Phase II | EXPERIMENTAL | This portion of the study further explores the clinical activity, safety, and PK of OP-1250 monotherapy at the RP2D and will estimate preliminary anti-tumor efficacy in 3 cohorts. Cohort A will enroll subjects with measurable disease without evidence of Central Nervous System (CNS) metastases; Cohort B will enroll subjects with non-measurable (evaluable) disease without evidence of CNS metastases; and Cohort C will enroll subjects with evaluable disease (measurable and non-measurable) with CNS metastases. |
| Name | Type | Description |
|---|---|---|
| OP-1250 | DRUG | Complete Estrogen Receptor ANtagonist (CERAN) |
Key Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Must have received at least 1 prior hormonal regimen and at least 6 months of a prior continuous endocrine therapy for locally advanced or metastatic disease * Must not have received prior oral endocr...
OP-1250 is an investigational small molecule being studied for the treatment of Hormone Receptor Positive Breast Carcinoma, specifically in patients with advanced and/or metastatic HR+, HER2- breast cancer. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
OP-1250 is a small molecule designed to target hormone receptor positive breast cancer. It is being studied as a potential treatment for HR+, HER2- advanced or metastatic breast cancer, with its mechanism of action under investigation in clinical trials.
OP-1250 is being developed by Olema Pharmaceuticals, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol OLMA. The company is conducting clinical research to evaluate the safety and efficacy of this investigational drug.
OP-1250 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The Phase 1 study has been completed, and the drug remains under clinical investigation.
OP-1250 has been studied in one completed clinical trial, identified as NCT04505826. This was a dose escalation and expansion study in subjects with advanced and/or metastatic HR+, HER2- breast cancer, conducted in the United States and Australia with 153 participants.
OP-1250 is the primary name for this investigational drug. No alternative names have been reported in the available clinical trial information, and it is identified solely by this designation in the context of its development by Olema Pharmaceuticals.