Atirmociclib

DRUG4 trials

Conditions

Advanced Breast CancerAdvanced CancerAdvanced Solid TumorsBreast CancerER-positive Breast CancerHER2-negative Breast CancerLocally Advanced Breast CancerMetastatic Breast Cancer

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: 792Updated: 2026-03-16

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

RecruitingNCT06239467

OnKure, Inc.Advanced Cancer, Advanced Solid Tumors, Breast Cancer +1

Start: 2024-02-26End: 2027-08-01Target: 200Updated: 2025-09-09

Phase 2

Study to Evaluate the Safety and Tolerability of Camizestrant in Combination With Atirmociclib in Women With Advanced Breast Cancer

Not yet recruitingNCT07427394

AstraZenecaAdvanced Breast Cancer

Start: 2026-04-10End: 2027-12-03Target: 24Updated: 2026-02-23

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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