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palazestrant

Generic: Palazestrant·Code: OP-1250

palazestrant: developed by 1 company · 6 clinical trials tracked.

palazestrant evidence translation

What we can confirm

What it means

Source-backed records connect palazestrant to OLMA; that link alone does not prove the drug works.

What to watch

Watch trial status, endpoints, and the next source-backed update.
BioSniper AIPage evidence connected

Prepared research question

How could palazestrant → OLMA affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence4 indications · 0 study sponsors

Related indications

Breast Cancer; Advanced or Metastatic ER+ HER2- Breast Cancer (mBC); Metastatic Breast CancerAdvanced Breast CancerBreast CancerMetastatic Breast Cancer

Study sponsors

No additional listed-company sponsor is linked.

Development Pipeline (3)
CompanyPhase
Olema Pharmaceuticals, Inc. (OLMA)
Breast Cancer; Advanced or Metastatic ER+ HER2- Breast Cance…
Phase 3
Olema Pharmaceuticals, Inc. (OLMA)
Breast Cancer; Advanced or Metastatic ER+ HER2- Breast Cance…
Phase 3
Olema Pharmaceuticals, Inc. (OLMA)
Breast Cancer; Advanced or Metastatic ER+ HER2- Breast Cance…
Phase 3
Clinical Trials (6)

A Phase 3 Randomized, Double-Blind, Active-Controlled Study of Palazestrant With Ribociclib Versus Letrozole With Ribociclib for the First-Line Treatment of ER+, HER2- Advanced Breast Cancer (OPERA-02)

NCT07085767·Phase 3·OLMA
Recruiting

Primary endpoint: Progression-Free Survival (PFS)

InterventionalRandomizedtriple1,000 targetStarted 2025-11Completion 2032-0150 sites · Australia, United StatesOlema Pharmaceuticals, Inc.

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

NCT06784193·Phase 1·OLMA
Recruiting

Primary endpoint: Number of participants with dose-limiting toxicities in the Dose Escalation Arms

InterventionalRandomizedopen180 targetStarted 2024-12Completion 2027-088 sites · Australia, United StatesOlema Pharmaceuticals, Inc.

A Phase 3 Randomized, Open-Label Study of OP-1250 Monotherapy vs Standard of Care for the Treatment of ER+, HER2- Advanced or Metastatic Breast Cancer Following Endocrine and CDK 4/6 Inhibitor Therapy (OPERA-01)

NCT06016738·Phase 3·OLMA
Active, not recruiting

Primary endpoint: Dose-Selection Part: Incidence of adverse events

InterventionalRandomizedopen510 targetStarted 2023-11Completion 2028-0250 sites · Argentina, United StatesOlema Pharmaceuticals, Inc.

A Phase 1b Open-Label Multicenter Study of OP-1250 (Palazestrant) in Combination With the CDK4/6 Inhibitor Ribociclib, With the PI3K Inhibitor Alpelisib, With the mTOR Inhibitor Everolimus, or With CDK4 Inhibitor Atirmociclib in Adult Subjects With Advanced and/or Metastatic ER Positive, HER2 Negative Breast Cancer

NCT05508906·Phase 1·OLMA
Recruiting

Primary endpoint: Dose Limiting Toxicities (DLTs)

Interventionalopen190 targetStarted 2022-08Completion 2028-0116 sites · Australia, United StatesOlema Pharmaceuticals, Inc.

A Phase 1 Dose Escalation and Expansion Open-label, Multicenter, Study of OP-1250 in Combination With the CDK4/6 Inhibitor Palbociclib in Adult Subjects With Advanced or Metastatic HR-positive, HER2-negative Breast Cancer

NCT05266105·Phase 1·OLMA
Active, not recruiting

Primary endpoint: Incidence of Dose Limiting Toxicities

Interventionalopen60 enrolledStarted 2021-12Completion 2026-038 sites · AustraliaOlema Pharmaceuticals, Inc.

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

NCT04505826·Phase 1/Phase 2·OLMA
Completed

Primary endpoint: Dose Limiting Toxicities (DLT)

Interventionalopen153 enrolledStarted 2020-08Completion 2024-0719 sites · Australia, United StatesOlema Pharmaceuticals, Inc.

Frequently asked questions

Who is developing palazestrant?

palazestrant is being developed by Olema Pharmaceuticals, Inc..

How many clinical trials involve palazestrant?

BioSniper tracks 6 clinical trials involving palazestrant.