Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
OP-3136 · 1 trial · 6 indications
| Arm | Type | Description |
|---|---|---|
| Part 1A Dose Escalation monotherapy | EXPERIMENTAL | - |
| Part 1B Dose Escalation in combination with fulvestrant | EXPERIMENTAL | - |
| Part 1C Dose Escalation in combination with palazestrant | EXPERIMENTAL | - |
| Part 2A Dose Expansion monotherapy - mBC | EXPERIMENTAL | - |
| Part 2A Dose Expansion monotherapy - mCRPC | EXPERIMENTAL | - |
| Part 2B Dose Expansion in combination with fulvestrant OR palazestrant-mBC @ RDE 1 | EXPERIMENTAL | - |
| Part 2B Dose Expansion in combination with fulvestrant OR palazestrant-mBC @ RDE 2 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| OP-3136 | DRUG | Selective inhibitor of HAT enzymes KAT6A and KAT6B |
| Fulvestrant | DRUG | Selective estrogen receptor degrader (SERD) |
| Palazestrant | DRUG | Complete estrogen receptor antagonist (CERAN) |
Key Inclusion Criteria: * Participants with advanced or metastatic ER+HER2- breast cancer, mCRPC, or NSCLC (Part 1) or advanced or metastatic ER+HER2- BC or mCRPC (Part 2). * Part 1A (Dose escalation for OP-3136 monotherapy): Participants must have a tumor that is unresectable or metastatic and for...
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OP-3136 is an investigational small molecule developed by Olema Pharmaceuticals, Inc. (ticker OLMA) for advanced or metastatic ER+ HER2- breast cancer. It is also being studied in advanced or metastatic non-small cell lung cancer and castration-resistant prostate cancer. It is currently in Phase 1 clinical development and has not been approved by the FDA.
OP-3136 is being developed for the treatment of advanced or metastatic ER+ HER2- breast cancer (mBC). The Phase 1 study also enrolls patients with advanced or metastatic non-small cell lung cancer and castration-resistant prostate cancer. OP-3136 is investigational and has not been approved for any indication.
OP-3136 targets KAT6, a lysine acetyltransferase enzyme. By inhibiting KAT6, the drug is designed to interfere with acetyltransferase activity in cancer cells. This targeted mechanism is being evaluated in a biomarker-selected patient population in the ongoing Phase 1 trial.
OP-3136 is being developed by Olema Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker symbol OLMA. The company is the sponsor of the Phase 1 clinical trial evaluating OP-3136 in advanced or metastatic solid tumors.
OP-3136 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The single ongoing Phase 1 trial is currently recruiting participants and has an estimated enrollment of 180 patients.
OP-3136 is being evaluated in one active clinical trial, NCT06784193, titled Phase 1 Study of OP-3136 in Advanced or Metastatic Solid Tumors. The trial is recruiting, is controlled and randomized, has an estimated enrollment of 180 participants, and is running in the United States, Australia, France, Hong Kong, Ireland, and Spain.