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

Part of paid clinical trials in Sarasota, Florida.

Sponsor
Olema Pharmaceuticals, Inc.
Study ID
NCT06784193
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • OP-3136 — DRUG
    Selective inhibitor of HAT enzymes KAT6A and KAT6B
  • Fulvestrant — DRUG
    Selective estrogen receptor degrader (SERD)
  • Palazestrant — DRUG
    Complete estrogen receptor antagonist (CERAN)

Study Details

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).

Key Dates

Start date
Dec 16, 2024
Status verified
Sep 2025
Primary completion
May 30, 2027
Completion
Aug 30, 2027

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1A Dose Escalation monotherapy
  • Experimental: Part 1B Dose Escalation in combination with fulvestrant
  • Experimental: Part 1C Dose Escalation in combination with palazestrant
  • Experimental: Part 2A Dose Expansion monotherapy - mBC
  • Experimental: Part 2A Dose Expansion monotherapy - mCRPC
  • Experimental: Part 2B Dose Expansion in combination with fulvestrant OR palazestrant-mBC @ RDE 1
  • Experimental: Part 2B Dose Expansion in combination with fulvestrant OR palazestrant-mBC @ RDE 2

Primary Outcome Measure

Number of participants with dose-limiting toxicities in the Dose Escalation Arms [ Time Frame: Up to 28 days ]

Central Contacts

  • There may be multiple sites in this clinical trial Olema Clinical Trial Lead
    415-651-7206
    [email protected]
  • Olema Medical Study Director

Locations (7)

FacilityCityStateZIPSite coordinators
Florida Cancer SpecialistsSarasotaFlorida34232-
University Medical Center - New OrleansNew OrleansLouisiana70112-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
START - MidwestGrand RapidsMichigan49546-
SCRI Oncology PartnersNashvilleTennessee37203-
START - San AntonioSan AntonioTexas78229-
START - Mountain RegionWest Valley CityUtah84119-

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Florida Cancer Specialists· Sarasota, FLUniversity Medical Center - New Orleans· New Orleans, LADana-Farber Cancer Institute· Boston, MASTART - Midwest· Grand Rapids, MISCRI Oncology Partners· Nashville, TNSTART - San Antonio· San Antonio, TX

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