Brief Summary
This is a first-in-human, open-label, multicenter phase 1 study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of OP-3136, a lysine acetyltransferases 6A and 6B (KAT6A/B) inhibitor, in participants with advancedat a late stage, far along solid tumors.
This study consists of 2 parts: a dosethe amount of medication taken escalation part (Part 1) and dose expansion part (Part 2).
Intervention / Treatment
- Drug: OP-3136
Inclusion Criteria:
- Participants with advanced or metastatic ER+HER2- breast cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs, mCRPC, or NSCLC (Part 1) or advanced or metastatic ER+HER2- BC or mCRPC (Part 2).
- Part 1 (Dose escalation): 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 2 (Dose Expansion in ER+ HER2- mBC): 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 chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells or an antibody-drug conjugate.
- Part 2 (Dose Expansion in mCRPC): Participants must have received up to 4 lines of prior systemic therapy for prostatea walnut-shaped gland in the male reproductive system that is responsible for producing semen - a bodily fluid that acts as a vessel for sperm transport during ejaculation cancer. Prior therapy must include treatment with an androgen receptor pathway inhibitor(s).