Hormone Receptor Positive Breast CarcinomaPhase 1/2NCT04505826

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

A Phase 1/2 study testing OP-1250 in people with Hormone Receptor Positive Breast Carcinoma and HER2-negative Breast Cancer, run by Olema Pharmaceuticals, Inc. at 19 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This clinical trial is a Phase I dose escalation and dose expansion and Phase II monotherapy open-label, first-in-human, multicenter study of OP-1250 in adult subjects with advanced and/or metastatic hormone receptor (HR)-positive, her2-negative breast cancer. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hormone Receptor Positive Breast Carcinoma, HER2-negative Breast Cancer
What is being tested?: OP-1250
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 153 participants
Where: 19 sitesin 2 countries
Study dates: 13 Aug 2020to 30 Jul 2024
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Must have received at least 1 prior hormonal regimen and at least 6 months of a prior continuous endocrine therapy for locally advanced or metastatic disease
Must not have received prior oral endocrine therapy < 2 weeks prior to first dose
Must not have received prior, chemotherapy in 2 weeks or within 5 half-lives whichever is earlier, antibody therapy within 4 weeks or investigational therapy within 4 weeks or 5 half-lives whichever is earlier, prior to the first dose
Adequate hepatic function
Adequate renal function
Normal coagulation panel
Willingness to use effective contraception

Who cannot join

Gastrointestinal disease
Significant renal disease
Significant cardiovascular disease
Significant ECG abnormalities
Ongoing systemic bacterial, fungal, or viral infection (requiring antimicrobial therapy)
Pregnancy or breastfeeding

Trial locations and contacts

19 sites in 2 countries.

Country

City, postcode or hospital

19 sites in 2 countries

United States15 sites

Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
University of Colorado
Aurora, Colorado, 80045
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
University of Miami, Sylvester Comprehensive Cancer Center
Deerfield Beach, Florida, 33442
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
UCLA Hematology/Oncology
Los Angeles, California, 90404
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Advent Health
Orlando, Florida, 32804
Providence Portland Medical Center
Portland, Oregon, 97213
OHSU Knight Cancer Institute
Portland, Oregon, 97239
Florida Cancer Center
Sarasota, Florida, 34232
Montefiore Medical Center
The Bronx, New York, 10461

Other trials in United States

Australia4 sites

Cancer Research South Australia
Adelaide, South Australia, 5000
ICON Cancer Centre
Auchenflower, Queensland, 4066
Macquarie University
Sydney, New South Wales, 2109
Westmead
Westmead, New South Wales, 2145

Other trials in Australia

About this study

Official title: A Phase I Dose Escalation and Dose Expansion and Phase II Monotherapy Open-label, First-in-Human, Multicenter Study of OP-1250 in Adult Subjects With Advanced and/or Metastatic Hormone Receptor (HR)-Positive, HER2-negative Breast Cancer

Read the detailed description

This is a Phase I dose escalation and dose expansion and Phase II monotherapy open--label, first--in--human study to determine the dose limiting toxicity (DLT), maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D), to characterize the safety and pharmacokinetic (PK) profile, and to estimate the preliminary anti-tumor activity of OP-1250 as a single agent in adult subjects with hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative metastatic or locally advanced breast cancer. This study comprises 2 Phases: Phase I (Part A [Dose Escalation] and Part B [Dose Expansion]) and Phase II. Patients must have received at least 1 prior hormonal regimen and at least 6 months of a prior continuous endocrine therapy for locally advanced or metastatic disease. Patients will be evaluated for treatment emergent adverse events (AEs) during study participation, and toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 5.0.

Conditions: Hormone Receptor Positive Breast Carcinoma, HER2-negative Breast Cancer
Being tested: OP-1250

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OP-1250Drug
Complete Estrogen Receptor ANtagonist (CERAN)

Study groups in NCT04505826
Study group	Role	What they receive
OP-1250 Phase I Part A (Dose Escalation)	Experimental	Phase I Part A will evaluate the safety and pharmacokinetics (PK)of a range of OP-1250 doses to identify the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D). Receives: Drug: OP-1250
OP-1250 Phase I Part B (Dose Expansion)	Experimental	Phase I Part B will evaluate the safety and PK of OP-1250 to confirm the RP2D dose. Receives: Drug: OP-1250
OP-1250 Phase II	Experimental	This portion of the study further explores the clinical activity, safety, and PK of OP-1250 monotherapy at the RP2D and will estimate preliminary anti-tumor efficacy in 3 cohorts. Cohort A will enroll subjects with measurable disease without evidence of Central Nervous System (CNS) metastases; Cohort B will enroll subjects with non-measurable (evaluable) disease without evidence of CNS metastases; and Cohort C will enroll subjects with evaluable disease (measurable and non-measurable) with CNS metastases. Receives: Drug: OP-1250

What is being measured

The primary outcome is the main question the study is designed to answer.

Dose Limiting Toxicities (DLT)
Number of Participants with Dose Limiting Toxicities (DLT) during Dose Escalation Only
Measured: Up to 28 days from start of treatment
Characterize the Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) of OP-1250 That Had at Least One Treatment Emergent Adverse Event
Characterize the incidence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of OP-1250 in patients that had at least one treatment emergent adverse event according to NCI-CTCAE version 5.0.
Measured: Up to 3 years, 11 months, and 17 days.
Pharmacokinetics of OP-1250
Plasma concentrations of OP-1250 assessed steady state
Measured: AUC (0-24) at steady state after 4 weeks of administration
Anti-tumor Activity of OP-1250 (cPR)
Tumor response will be evaluated in patients with measurable or evaluable disease, using RECISTv1.1 guidelines (Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR)). Overall response rate which includes confirmed Partial Response (cPR).
Measured: Imaging studies performed every 8 weeks from date of first dose through cycle 9 then afterwards every 12 weeks until date of first documented disease progression: assessed up to 3 years, 11 months, and 17 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Aug 202030 Jul 2024

First posted10 Aug 2020
Study start13 Aug 2020
Primary completion30 Jul 2024
Study completion30 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hormone Receptor Positive Breast CarcinomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 153 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04505826
Sponsor's protocol ID: OP-1250-001
Status last verified: Apr 2026
First submitted: 21 Jul 2020
Last updated: 11 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Hamilton EP, Patel MR, Borges VF, Meisel JL, Okera M, Alemany CA, Pluard TJ, Wesolowski R, Sabanathan D, Miller KD, Conlin AK, McCarthy N, Shaw M, Tonda M, Shilkrut M, Lin NU. Palazestrant, a novel oral Complete Estrogen Receptor Antagonist (CERAN) and Selective Estrogen Receptor Degrader (SERD), in patients with ER+/HER2- advanced or metastatic breast cancer: phase 1/2 study results. Breast Cancer Res. 2025 Jul 1;27(1):119. doi: 10.1186/s13058-025-02049-y.
PubMed 40598566

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Not yet recruiting
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RecruitingObservational study
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RecruitingPhase 3
Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer
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All Hormone Receptor Positive Breast Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Dose Escalation and Dose Expansion and Phase II Monotherapy Open-label, First-in-Human, Multicenter Study of OP-1250 in Adult Subjects With Advanced and/or Metastatic Hormone Receptor (HR)-Positive, HER2-negative Breast Cancer
ClinicalTrials.gov ID: NCT04505826
Acronym / sponsor ID: OP-1250-001
Conditions: Hormone Receptor Positive Breast Carcinoma, HER2-negative Breast Cancer
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 153 participants (actual)
Lead sponsor: Olema Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 13 Aug 2020 (actual)
Primary completion: 30 Jul 2024 (actual)
Study completion: 30 Jul 2024 (actual)
First posted: 10 Aug 2020 (actual)
Results: Posted 11 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
OP-1250 Phase I Part A (Dose Escalation)	Experimental	Drug: OP-1250Phase I Part A will evaluate the safety and pharmacokinetics (PK)of a range of OP-1250 doses to identify the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D).
OP-1250 Phase I Part B (Dose Expansion)	Experimental	Drug: OP-1250Phase I Part B will evaluate the safety and PK of OP-1250 to confirm the RP2D dose.
OP-1250 Phase II	Experimental	Drug: OP-1250This portion of the study further explores the clinical activity, safety, and PK of OP-1250 monotherapy at the RP2D and will estimate preliminary anti-tumor efficacy in 3 cohorts. Cohort A will enroll subjects with measurable disease without evidence of Central Nervous System (CNS) metastases; Cohort B will enroll subjects with non-measurable (evaluable) disease without evidence of CNS metastases; and Cohort C will enroll subjects with evaluable disease (measurable and non-measurable) with CNS metastases.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Must have received at least 1 prior hormonal regimen and at least 6 months of a prior continuous endocrine therapy for locally advanced or metastatic disease
Must not have received prior oral endocrine therapy < 2 weeks prior to first dose
Must not have received prior, chemotherapy in 2 weeks or within 5 half-lives whichever is earlier, antibody therapy within 4 weeks or investigational therapy within 4 weeks or 5 half-lives whichever is earlier, prior to the first dose
Adequate hepatic function

Key exclusion criteria (6 listed)

Gastrointestinal disease
Significant renal disease
Significant cardiovascular disease
Significant ECG abnormalities
Ongoing systemic bacterial, fungal, or viral infection (requiring antimicrobial therapy)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OP-1250Complete Estrogen Receptor ANtagonist (CERAN)	Drug	OP-1250 Phase I Part A (Dose Escalation), OP-1250 Phase I Part B (Dose Expansion), OP-1250 Phase II

Primary outcome

Dose Limiting Toxicities (DLT)
Time frame: Up to 28 days from start of treatment
Number of Participants with Dose Limiting Toxicities (DLT) during Dose Escalation Only
Characterize the Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) of OP-1250 That Had at Least One Treatment Emergent Adverse Event
Time frame: Up to 3 years, 11 months, and 17 days.
Characterize the incidence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of OP-1250 in patients that had at least one treatment emergent adverse event according to NCI-CTCAE version 5.0.
Pharmacokinetics of OP-1250
Time frame: AUC (0-24) at steady state after 4 weeks of administration
Plasma concentrations of OP-1250 assessed steady state
Anti-tumor Activity of OP-1250 (cPR)
Time frame: Imaging studies performed every 8 weeks from date of first dose through cycle 9 then afterwards every 12 weeks until date of first documented disease progression: assessed up to 3 years, 11 months, and 17 days
Tumor response will be evaluated in patients with measurable or evaluable disease, using RECISTv1.1 guidelines (Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR)). Overall response rate which includes confirmed Partial Response (cPR).

Results and safety

Results posted to the registry on 11 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
30 mg QD (Phase 1a)	5	5
60 mg QD (Phase 1a)	6	6
60 mg (Phase 1b)	27	26
90 mg QD (Phase 1a)	6	6
120 mg QD (Phase 1a)	6	6
120 mg QD (Phase 1b)	29	29
120 mg QD (Phase 2)	48	46
150 mg QD (Phase 1a)	5	5
210 mg QD (Phase 1a)	7	7
300 mg QD (Phase 1a)	7	7
120 mg QD (Phase 2COHORT C ONLY)	7	7

Primary outcome: Dose Limiting Toxicities (DLT)

Time frame: Up to 28 days from start of treatment. Count of participants. Unit: Participants

Measure	30 mg QD (Phase 1a) n = 5	60 mg QD (Phase 1a) n = 6	90 mg QD (Phase 1a) n = 6	120 mg QD (Phase 1a) n = 6	150 mg QD (Phase 1a) n = 5	210 mg QD (Phase 1a) n = 7	300 mg QD (Phase 1a) n = 7	TOTAL (Phase 1a) n = 42	60 mg QD (Phase 1b) n = 0	120 mg QD (Phase1b) n = 0	Cohort A (Phase 2) n = 0	Cohort B (Phase 2) n = 0	Cohort C (Phase 2) n = 0
Value	0	0	0	0	0	0	0	0	0	0	0	0	0

Population analysed: Per the protocol DLTs were evaluated at Escalation phase (1a) only

Primary outcome: Characterize the Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) of OP-1250 That Had at Least One Treatment Emergent Adverse Event

Time frame: Up to 3 years, 11 months, and 17 days.. Count of participants. Unit: Participants

Measure	30 mg QD n = 5	60 mg QD n = 33	90 mg QD n = 6	120 mg QD n = 83	150 mg QD n = 5	210 mg QD n = 7	300 mg QD n = 7	120 mg QD (COHORT C ONLY) n = 7
Value	5	29	5	79	5	7	7	6

Primary outcome: Pharmacokinetics of OP-1250

Time frame: AUC (0-24) at steady state after 4 weeks of administration. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL*h

Measure	30mg QD n = 5	60mg QD n = 26	90mg QD n = 6	120mg QD n = 77	150mg QD n = 2	210mg QD n = 6	300mg QD n = 6
Value	1956 (33.0)	4014 (46.2)	7668 (82.4)	9163 (38.1)	12580 (27.3)	22439 (47.2)	25438 (40.2)

Population analysed: Includes AUC (ng·h/mL) at steady state for subjects treated across all dose levels.

Primary outcome: Anti-tumor Activity of OP-1250 (cPR)

Time frame: Imaging studies performed every 8 weeks from date of first dose through cycle 9 then afterwards every 12 weeks until date of first documented disease progression: assessed up to 3 years, 11 months, and 17 days. Count of participants. Unit: Participants

Measure	30mg QD n = 5	60mg QD n = 28	90mg QD n = 4	120mg QD n = 62	150mg QD n = 1	210mg QD n = 4	300mg QD n = 4	120 mg QD (COHORT C ONLY) n = 5
Value	0	2	0	4	0	0	0	0

Population analysed: Participants analyzed were evaluable for response which includes measurable disease. Overall response rate uses confirmed Partial Response (cPR)

Adverse events

Time frame: From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
30 mg QD	0 of 5 (0%)	5 of 5 (100%)	1 of 5
60 mg QD	4 of 33 (12.1%)	29 of 33 (87.9%)	5 of 33
90 mg QD	2 of 6 (33.3%)	5 of 6 (83.3%)	1 of 6
120 mg QD	16 of 83 (19.3%)	79 of 83 (95.2%)	5 of 83
150 mg QD	2 of 5 (40%)	5 of 5 (100%)	1 of 5
210 mg QD	2 of 7 (28.6%)	7 of 7 (100%)	1 of 7
300 mg QD	2 of 7 (28.6%)	7 of 7 (100%)	1 of 7
120 mg QD (COHORT C ONLY)	4 of 7 (57.1%)	6 of 7 (85.7%)	2 of 7

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40598566Hamilton EP, Patel MR, Borges VF, Meisel JL, Okera M, Alemany CA, Pluard TJ, Wesolowski R, Sabanathan D, Miller KD, Conlin AK, McCarthy N, Shaw M, Tonda M, Shilkrut M, Lin NU. Palazestrant, a novel oral Complete Estrogen Receptor Antagonist (CERAN) and Selective Estrogen Receptor Degrader (SERD), in patients with ER+/HER2- advanced or metastatic breast cancer: phase 1/2 study results. Breast Cancer Res. 2025 Jul 1;27(1):119. doi: 10.1186/s13058-025-02049-y.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Margaret Tonda study director

Olema Pharmaceuticals, Inc.

19 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing OP-1250 in people with Hormone Receptor Positive Breast Carcinoma and HER2-negative Breast Cancer, run by Olema Pharmaceuticals, Inc. at 19 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limiting Toxicities (DLT) (time frame: Up to 28 days from start of treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04505826, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.