Atirmociclib

DRUG5 trials

Conditions

Advanced Breast CancerAdvanced CancerAdvanced Solid TumorsBreast CancerER-positive Breast CancerHER2-negative Breast CancerHealthy AdultsHealthy, Hepatic Insufficiency

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: 2026-07-15

Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer

RecruitingNCT05508906

Olema Pharmaceuticals, Inc.Breast Cancer, ER-positive Breast Cancer, HER2-negative Breast Cancer +2

Start: 2022-08-31End: 2028-01-31Target: 190Updated: 2025-10-22

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

Not yet recruitingNCT07677358

PfizerHealthy Adults, Healthy, Hepatic Insufficiency, Hepatic Impairment

Start: 2026-07-09End: 2027-09-10Target: 28Updated: 2026-06-30

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: 2027-12-03Target: 24Updated: 2026-07-13

Clinical Cancer Research2026-02-17

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

Clinical Cancer Research2025-06-13

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

Clinical Cancer Research2025-06-13

Safety overview and management of inavolisib alone and in combination therapies in PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer (GO39374).

2025-06-121 citations

TROPION-Breast05: a randomized phase III study of Dato-DXd with or without durvalumab versus chemotherapy plus pembrolizumab in patients with PD-L1-high locally recurrent inoperable or metastatic triple-negative breast cancer

Therapeutic Advances in Medical Oncology2025-01-0110 citations

Abstract PO4-04-12: A Phase 1b/2 study of palazestrant (OP-1250) in combination with ribociclib or alpelisib in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative, advanced and/or metastatic breast cancer

Cancer Research2024-05-021 citations

181O Interim analysis (IA) of the atezolizumab (atezo) + sacituzumab govitecan (SG) arm in patients (pts) with triple-negative breast cancer (TNBC) in MORPHEUS-pan BC: A phase Ib/II study of multiple treatment (tx) combinations in pts with locally advanced/metastatic BC (LA/mBC)

ESMO Open2024-05-0118 citations

212P A phase Ib/II study of palazestrant (OP-1250) in combination with ribociclib in patients with estrogen receptor-positive human epidermal growth factor receptor 2-negative (ER+, HER2-) metastatic breast cancer

ESMO Open2024-05-016 citations

Selective immune suppression using interleukin-6 receptor inhibitors for management of immune-related adverse events

Journal for ImmunoTherapy of Cancer2023-06-0183 citations

A phase 1b/2 dose escalation and expansion study of OP-1250 in combination with ribociclib or alpelisib in patients with advanced and/or metastatic estrogen receptor–positive (ER+)/HER2-negative (HER2-) breast cancer.

Journal of Clinical Oncology2023-06-019 citations

Phase I Trial of Ipatasertib Plus Carboplatin, Carboplatin/Paclitaxel, or Capecitabine and Atezolizumab in Metastatic Triple-Negative Breast Cancer

The Oncologist2023-04-0614 citations

Abstract PD10-04: Phase Ib/II open-label, randomized trial of atezolizumab (atezo) with ipatasertib (ipat) and fulvestrant (fulv) vs control in MORPHEUS-HR+ breast cancer (M-HR+ BC) and atezo with ipat vs control in MORPHEUS triple negative breast cancer (M-TNBC)

Cancer Research2022-02-153 citations

Phase I study of ABBV-428, a mesothelin-CD40 bispecific, in patients with advanced solid tumors

Journal for ImmunoTherapy of Cancer2021-02-0156 citations

259 Phase Ib/II open-label, randomized evaluation of atezolizumab (atezo) + selicrelumab (seli) + gemcitabine+nab-paclitaxel (gem+nabP) or bevacizumab (bev) vs control in MORPHEUS-PDAC, -TNBC and -CRC

Regular and Young Investigator Award Abstracts2020-11-012 citations

Abstract OT2-06-04: MORPHEUS: A phase Ib/II trial platform evaluating the safety and efficacy of multiple cancer immunotherapy combinations in patients with hormone receptor–positive and triple-negative breast cancer

Cancer Research2019-02-1511 citations

MORPHEUS: A phase Ib/II umbrella study platform evaluating the safety and efficacy of multiple cancer immunotherapy (CIT)-based combinations in different tumour types

Annals of Oncology2018-10-0119 citations

Atirmociclib

Sponsors

Conditions

Phase 1

Phase 2

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