Phase
Condition
N/ATreatment
OP-3136
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 ormetastatic and for which life prolonging measures do not exist or availabletherapies are intolerable or no longer effective.
Part 2 (Dose Expansion in ER+ HER2- mBC): Participants must have received up to 3prior lines of endocrine therapy (one of which must be in combination with CDK4/6inhibitor) 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 ofprior systemic therapy for prostate cancer. Prior therapy must include treatmentwith an androgen receptor pathway inhibitor(s).
Exclusion
Key Exclusion Criteria:
Prior therapy with KAT6A/B inhibitor in any treatment setting.
Participants with advanced/metastatic, symptomatic, visceral spread, that are atrisk of life-threatening complications in the short term.
Known active or symptomatic central nervous system (CNS) metastases, carcinomatousmeningitis, leptomeningeal disease, or a spinal cord compression that requireCNS-specific treatment, or participants who did not demonstrate clinical andradiologic stability during the last 2 months prior to the first dose of studytreatment or require or are currently on steroid therapy for CNS metastases.
History of cerebral vascular disease, including transient ischemic attack, within 6months prior to the first dose of study treatment.
History of or ongoing impaired cardiac function or clinically significant cardiacdisease within 6 months prior to the first dose of study treatment.
Note: Additional inclusion/exclusion criteria may apply.
Study Design
Study Description
Connect with a study center
Cancer Research South Australia
Adelaide, South Australia 5000
AustraliaActive - Recruiting
Florida Cancer Specialists
Sarasota, Florida 34232
United StatesActive - Recruiting
University Medical Center - New Orleans
New Orleans, Louisiana 70112
United StatesActive - Recruiting
START - Midwest
Grand Rapids, Michigan 49546
United StatesActive - Recruiting
SCRI Oncology Partners
Nashville, Tennessee 37203
United StatesActive - Recruiting
START - San Antonio
San Antonio, Texas 78229
United StatesActive - Recruiting
START - Mountain Region
West Valley City, Utah 84119
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.