RECRUITING

Phase 1 Study of OP-3136 in Advanced or Metastatic Solid Tumors

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Phase 1 First-in-Human, Open-Label, Multicenter Study of OP-3136 in Adult Participants With Advanced or Metastatic Solid Tumors

Quick Facts

Study Start:2024-12-16
Study Completion:2027-08-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06784193

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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).
  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.
  3. * 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 3 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.
  4. * 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.
  5. * 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).
  6. * Part 2B (Dose Expansion in ER+ HER2- mBC for OP-3136 in combination with fulvestrant): 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.
  1. * Prior therapy with KAT6A/B inhibitor in any treatment setting.
  2. * Participants with advanced/metastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term.
  3. * 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.
  4. * History of cerebral vascular disease, including transient ischemic attack, within 6 months prior to the first dose of study treatment.
  5. * History of or ongoing impaired cardiac function or clinically significant cardiac disease within 6 months prior to the first dose of study treatment.

Contacts and Locations

Study Contact

There may be multiple sites in this clinical trial Olema Clinical Trial Lead
CONTACT
415-651-7206
clinical@olema.com
Olema Medical Study Director
CONTACT

Study Locations (Sites)

Florida Cancer Specialists
Sarasota, Florida, 34232
United States
University Medical Center - New Orleans
New Orleans, Louisiana, 70112
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
START - Midwest
Grand Rapids, Michigan, 49546
United States
SCRI Oncology Partners
Nashville, Tennessee, 37203
United States
START - San Antonio
San Antonio, Texas, 78229
United States
START - Mountain Region
West Valley City, Utah, 84119
United States

Collaborators and Investigators

Sponsor: Olema Pharmaceuticals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-16
Study Completion Date2027-08-30

Study Record Updates

Study Start Date2024-12-16
Study Completion Date2027-08-30

Terms related to this study

Keywords Provided by Researchers

  • KAT6 Inhibitor
  • Histone Acetyltransferase (HAT) Inhibitor
  • Epigenetic

Additional Relevant MeSH Terms

  • Advanced or Metastatic ER+ HER2- Breast Cancer (mBC)
  • Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
  • Advanced or Metastatic Castration-Resistant Prostate Cancer (mCRPC)
  • Metastatic Breast Cancer
  • Fulvestrant