Study of OP-3136 in Advanced or Metastatic Solid Tumors

Launched by OLEMA PHARMACEUTICALS, INC. · Jan 14, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called OP-3136 for patients with advanced solid tumors, specifically certain types of breast cancer, lung cancer, and prostate cancer. The study is designed to assess how safe and tolerable the treatment is, how it behaves in the body, and whether it shows signs of effectiveness. The trial is divided into two parts: the first part will look at different doses of the drug to find the best one, while the second part will focus on specific groups of breast and prostate cancer patients who have already tried several other treatments.

To participate in this trial, patients must have specific advanced cancer types that have not responded to previous treatments, or for which no treatment options are available. For example, participants with breast cancer must have already undergone several lines of hormone therapy and possibly chemotherapy. It's important to note that certain health conditions may exclude patients from joining, such as severe heart issues or recent significant brain problems. Those who qualify can expect regular check-ups and monitoring during the trial to ensure their safety while trying this new treatment.

Gender

ALL

Eligibility criteria

• 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 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 chemotherapy or an antibody-drug conjugate.
• • Part 2 (Dose Expansion in mCRPC): 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).
• 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.