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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 being developed for the treatment of advanced or metastatic ER+ HER2- breast cancer (mBC). It is also being studied in advanced or metastatic non-small cell lung cancer (NSCLC) and castration-resistant prostate cancer (mCRPC). The drug is currently in Phase 1 clinical development.
OP-3136 targets KAT6, a lysine acetyltransferase enzyme. By inhibiting KAT6, the drug may affect gene expression pathways involved in tumor growth. This mechanism is being evaluated in a Phase 1 study for advanced or metastatic solid tumors, including ER+ HER2- breast cancer.
OP-3136 is being developed by Olema Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol OLMA. The company is conducting a Phase 1 clinical trial of OP-3136 in patients with advanced or metastatic solid tumors.
OP-3136 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 study is recruiting participants to evaluate the safety, tolerability, and preliminary efficacy of OP-3136 in advanced or metastatic solid tumors.
OP-3136 is being studied in a Phase 1 clinical trial with the identifier NCT06784193. This trial is recruiting 180 participants with advanced or metastatic ER+ HER2- breast cancer, non-small cell lung cancer, or castration-resistant prostate cancer. The study is being conducted in the United States and Australia.
OP-3136 is not the same as palazestrant. Palazestrant is listed as a condition or treatment in the clinical trial for OP-3136, indicating it may be used as a combination agent or comparator in the study. OP-3136 is a distinct investigational drug targeting KAT6.