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Olema Pharmaceuticals

Olema Pharmaceuticals logo
🇺🇸United States
Ownership
Public
Established
2007-01-01
Employees
74
Market Cap
$668.8M
Website
http://www.olema.com

Clinical Trials

7

Active:2
Completed:0

Trial Phases

2 Phases

Phase 1:6
Phase 3:1

Drug Approvals

0

Drug Approvals

No drug approvals found

This company may not have drug approvals in our database

Clinical Trials

Distribution across different clinical trial phases (7 trials with phase data)• Click on a phase to view related trials

Phase 1
6 (85.7%)
Phase 3
1 (14.3%)

Study of OP-3136 in Advanced or Metastatic Solid Tumors

Phase 1
Recruiting
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)
Interventions
First Posted Date
2025-01-20
Last Posted Date
2025-05-15
Lead Sponsor
Olema Pharmaceuticals, Inc.
Target Recruit Count
90
Registration Number
NCT06784193
Locations
🇺🇸

Florida Cancer Specialists, Sarasota, Florida, United States

🇺🇸

University Medical Center - New Orleans, New Orleans, Louisiana, United States

🇺🇸

START - Midwest, Grand Rapids, Michigan, United States

and more 4 locations

OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer

Phase 3
Recruiting
Conditions
Metastatic Breast Cancer
HER2 Negative Breast Carcinoma
Breast Cancer
Advanced Breast Cancer
ER Positive Breast Cancer
Interventions
First Posted Date
2023-08-30
Last Posted Date
2025-05-28
Lead Sponsor
Olema Pharmaceuticals, Inc.
Target Recruit Count
510
Registration Number
NCT06016738
Locations
🇬🇧

Clinical Trial Site, London, United Kingdom

🇲🇾

Clinical Trials Site, Sungai Petani, Kedah, Malaysia

Phase 1b Combo w/ Ribociclib, Alpelisib, or Everolimus

Phase 1
Recruiting
Conditions
Metastatic Breast Cancer
Advanced Breast Cancer
ER-positive Breast Cancer
HER2-negative Breast Cancer
Breast Cancer
Interventions
First Posted Date
2022-08-19
Last Posted Date
2024-10-03
Lead Sponsor
Olema Pharmaceuticals, Inc.
Target Recruit Count
155
Registration Number
NCT05508906
Locations
🇺🇸

Banner MD Anderson Cancer Center, Gilbert, Arizona, United States

🇺🇸

University of California San Francisco Health, San Francisco, California, United States

🇺🇸

University of Colorado Cancer Center, Aurora, Colorado, United States

and more 13 locations

A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HR+/HER2- Breast Cancer Patients

Phase 1
Active, not recruiting
Conditions
Breast Cancer
Interventions
First Posted Date
2022-03-04
Last Posted Date
2024-06-06
Lead Sponsor
Olema Pharmaceuticals, Inc.
Target Recruit Count
60
Registration Number
NCT05266105
Locations
🇦🇺

Site 6108, Waratah, New South Wales, Australia

🇦🇺

Site 6104, Westmead, New South Wales, Australia

🇦🇺

Site 6102, South Brisbane, Queensland, Australia

and more 5 locations

A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer

Phase 1
Active, not recruiting
Conditions
Hormone Receptor Positive Breast Carcinoma
HER2-negative Breast Cancer
Interventions
First Posted Date
2020-08-10
Last Posted Date
2023-08-22
Lead Sponsor
Olema Pharmaceuticals, Inc.
Target Recruit Count
153
Registration Number
NCT04505826
Locations
🇺🇸

UCLA Hematology/Oncology, Los Angeles, California, United States

🇺🇸

University of Colorado, Aurora, Colorado, United States

🇺🇸

University of Miami, Sylvester Comprehensive Cancer Center, Deerfield Beach, Florida, United States

and more 16 locations

News

Olema's KAT6 Inhibitor OP-3136 Shows Promising Anti-Tumor Activity Across Multiple Cancer Types

• Olema Oncology's novel KAT6 inhibitor OP-3136 demonstrated potent anti-tumor activity in preclinical models of ovarian, prostate, and non-small cell lung cancer, expanding its potential beyond breast cancer. • In ovarian cancer models, OP-3136 achieved sustained tumor regression over 28 days, while showing comparable efficacy to ribociclib in lung cancer models and dose-dependent tumor inhibition in prostate cancer. • The compound exhibited enhanced anti-tumor activity when combined with standard therapies like ribociclib and docetaxel, with patient recruitment currently ongoing in Phase 1 clinical trials.

Olema Oncology Advances Pivotal Phase 3 Trials for Palazestrant in Metastatic Breast Cancer

Olema Oncology is progressing its pivotal Phase 3 OPERA-01 trial of palazestrant monotherapy in second/third-line metastatic breast cancer, with top-line data anticipated in 2026.

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