Informations générales (source: ClinicalTrials.gov)
A Phase 1 First-in-Human, Open-Label, Multicenter Study of OP-3136 in Adult Participants With Advanced or Metastatic Solid Tumors
Interventional
Phase 1
Olema Pharmaceuticals, Inc. (Voir sur ClinicalTrials)
décembre 2024
août 2027
06 octobre 2026
This is a first-in-human, open-label, multicenter phase 1 study to evaluate safety,
tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of
OP-3136, a lysine acetyltransferases 6A and 6B (KAT6A/B) inhibitor, as monotherapy and in
combination with other anticancer agents in participants with advanced solid tumors.
This study consists of 2 parts: a dose escalation part (Part 1) and dose expansion part
(Part 2).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Joana Mourato RIBEIRO | 23/10/2026 15:45:34 | Contacter | ||
Critères
Tous
- 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 which life prolonging measures do not
exist or available therapies are intolerable or no longer effective.
- Part 1B (Dose escalation for OP-3136 in combination with fulvestrant): Participants
with advanced or metastatic ER+ HER2- breast cancer that have progressed on or after
at least 1 prior line of treatment that included endocrine therapy and CDK 4/6
inhibitor in advanced or metastatic setting and must have received no more than 2
prior lines of endocrine therapy (one of which must be in combination with CDK4/6
inhibitor) and no more than 1 prior line of chemotherapy or an antibody-drug
conjugate in the advanced or metastatic setting.
- Part 1C (Dose escalation for OP-3136 in combination with palazestrant): Participants
with advanced or metastatic ER+ HER2- breast cancer that have progressed on or after
at least 1 prior line of treatment that included endocrine therapy and CDK 4/6
inhibitor in advanced or metastatic setting and must have received no more than 2
prior lines of endocrine therapy (one of which must be in combination with CDK4/6
inhibitor) and no more than 1 prior line of chemotherapy or an antibody-drug
conjugate in the advanced or metastatic setting.
- Part 2A (Dose Expansion in ER+ HER2- mBC for OP-3136 monotherapy): Participants must
have received up to 3 prior lines of endocrine therapy (one of which must be in
combination with CDK4/6 inhibitor) and up to 1 prior line of chemotherapy or an
antibody-drug conjugate.
- Part 2A (Dose Expansion in mCRPC for OP-3136 monotherapy): Participants must have
received up to 4 lines of prior systemic therapy for prostate cancer. Prior therapy
must include treatment with an androgen receptor pathway inhibitor(s).
- Part 2B (Dose Expansion in ER+ HER2- mBC for OP-3136 in combination with fulvestrant
OR Dose Expansion in ER+ HER2- mBC for OP-3136 in combination with palazestrant):
Participants must have progressed on or after at least 1 prior line of treatment
that included endocrine therapy and CDK 4/6 inhibitor in advanced or metastatic
setting. Participants must have received no more than 2 prior lines of endocrine
therapy in the advanced or metastatic setting and no more than 1 prior line of
chemotherapy or an antibody-drug conjugate in the advanced or metastatic setting.
Key Exclusion Criteria:
- Prior therapy with KAT6A/B inhibitor in any treatment setting.
- Participants with advanced/metastatic, symptomatic, visceral spread, that are at
risk of life-threatening complications in the short term.
- Known active or symptomatic central nervous system (CNS) metastases, carcinomatous
meningitis, leptomeningeal disease, or a spinal cord compression that require
CNS-specific treatment, or participants who did not demonstrate clinical and
radiologic stability during the last 2 months prior to the first dose of study
treatment or require or are currently on steroid therapy for CNS metastases.
- History of cerebral vascular disease, including transient ischemic attack, within 6
months prior to the first dose of study treatment.
- History of or ongoing impaired cardiac function or clinically significant cardiac
disease within 6 months prior to the first dose of study treatment.
Note: Additional inclusion/exclusion criteria may apply.