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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 8 → 25 locations Eligibility criteria expanded, about 12 words Show 1 more changeShow less
    • Eligibility criteria expanded, about 12 words
  2. Enrollment target: 160 to 180 Interventions: Fulvestrant (Drug), OP-3136 (Drug) to Fulvestrant (Drug), OP-3136 (Drug), Palazestrant (Drug) · Eligibility criteria expanded, about 119 words · Study description expanded, about 53 words · 1 morev7 Show 4 more changesShow less
    • Interventions: Fulvestrant (Drug), OP-3136 (Drug) to Fulvestrant (Drug), OP-3136 (Drug), Palazestrant (Drug)
    • Eligibility criteria expanded, about 119 words
    • Study description expanded, about 53 words
    • Study arms: 5 to 7

    See this version in full on ClinicalTrials.gov ↗

  3. Enrollment target: 90 to 160 Study sites: 7 to 8 · Interventions: OP-3136 (Drug) to Fulvestrant (Drug), OP-3136 (Drug) · Eligibility criteria expanded, about 156 words · 3 morev6 Show 6 more changesShow less
    • Study sites: 7 to 8
    • Interventions: OP-3136 (Drug) to Fulvestrant (Drug), OP-3136 (Drug)
    • Eligibility criteria expanded, about 156 words
    • Study description expanded, about 81 words
    • Study arms: 3 to 5
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 6 to 7v5
  5. Study sites: 5 to 6v4
Show 2 earlier versionsHide 2 earlier versions
  1. Study sites: 3 to 5v3
  2. Study title shortened, about 2 wordsv2 See this version in full on ClinicalTrials.gov ↗
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Olema Pharmaceuticals, Inc.
6 trials monitored
See 1 trial at risk
Breast Cancer
5,213 trials monitored
See 271 trials at risk
Lung Cancer
4,057 trials monitored
See 217 trials at risk
Non-Small Cell Lung Cancer (NSCLC)
2,932 trials monitored
See 157 trials at risk
and 1 more disease
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).
Trial Details
NCT Number NCT06784193
Lead Sponsor Olema Pharmaceuticals, Inc.
Conditions 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, Palazestrant
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov