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Atirmociclib

DRUG7 trials

Sponsors

Hoffmann-La Roche, Olema Pharmaceuticals, Inc., OnKure, Inc., AstraZeneca, Pfizer

Conditions

Advanced Breast CancerAdvanced CancerAdvanced Solid TumorsAdvanced or Metastatic Breast CancerBreast CancerER-positive Breast CancerEarly Breast CancerEstrogen Receptor Positive (ER+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-)

Phase 1

A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
RecruitingNCT03424005
Hoffmann-La RocheMetastatic Breast Cancer
Start: 2018-03-30End: 2030-09-30Target: 1132Updated: 2026-10-09
Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer
Active, not recruitingNCT05508906
Olema Pharmaceuticals, Inc.Breast Cancer, ER-positive Breast Cancer, HER2-negative Breast Cancer +2
Start: 2022-08-31End: 2028-01-31Target: 190Updated: 2026-09-15
First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer
Active, not recruitingNCT06239467
OnKure, Inc.Advanced Cancer, Advanced Solid Tumors, Breast Cancer +1
Start: 2024-02-26End: 2027-08-01Target: 200Updated: 2026-07-06
A Study to Learn How the Study Medicine Called Atirmociclib is Handled by the Body in People With Normal Liver Function and Different Levels of Liver Disease
RecruitingNCT07677358
PfizerHealthy Adults, Healthy, Hepatic Insufficiency, Hepatic Impairment
Start: 2026-06-29End: 2027-09-10Target: 28Updated: 2026-08-21
A Study to Learn About the Study Medicine Called PF-08165784 in People With PIK3CA-Mutated Advanced or Metastatic Solid Tumors
Not yet recruitingNCT07897721
PfizerAdvanced Breast Cancer, Advanced or Metastatic Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-) +1
Start: 2026-11-09End: 2032-03-21Target: 268Updated: 2026-10-28

Phase 2

Study to Evaluate the Safety and Tolerability of Camizestrant in Combination With Atirmociclib in Women With Advanced Breast Cancer
RecruitingNCT07427394
AstraZenecaAdvanced Breast Cancer
Start: 2026-05-06End: 2027-12-28Target: 24Updated: 2026-09-29

Phase 3

A Study of a Medicine Called Atirmociclib in Combination With Giredestrant in Adult Participants With ER-positive, HER2-negative Early-stage Breast Cancer
Not yet recruitingNCT07890597
PfizerEarly Breast Cancer, Estrogen Receptor Positive (ER+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-)
Start: 2026-12-01End: 2042-08-20Target: 3800Updated: 2026-10-22

Related Papers

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Abstract P4-12-20: OKI-219 enhances activity of SOC therapies in double and triple combinations in pre-clinical PI3Kα H1047R mutant breast cancer models
Clinical Cancer Research2025-06-13
Abstract P2-09-16: A Phase 1b/2 study of palazestrant (OP-1250) in combination with ribociclib, in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-), advanced or metastatic breast cancer
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Abstract P4-07-23: Preliminary safety in the inavolisib + fulvestrant + ribociclib/abemaciclib arms of MORPHEUS-pan breast cancer: A Phase 1b/2 study of efficacy & safety of multiple treatment combinations in patients with metastatic/locally advanced breast cancer
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