Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04505826 | A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer | PHASE1 | COMPLETED | 153 | — | — | Aug 13, 2020 | Jul 30, 2024 | May 11, 2026 | 19 | United States, Australia |
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...