Samuraciclib

DRUG5 trials

Sponsors

Hoffmann-La Roche, Carrick Therapeutics Limited, Pfizer, University of Washington

Conditions

Borderline Resectable Pancreatic Ductal AdenocarcinomaBreast CancerInoperable, Locally Advanced or Metastatic, ER-positive Breast CancerLocally Advanced Breast CancerLocally Advanced Pancreatic Ductal AdenocarcinomaMetastatic Breast CancerResectable Pancreatic Ductal Adenocarcinoma

Phase 1

A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer

RecruitingNCT04802759

Hoffmann-La RocheInoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer

Start: 2021-06-22End: 2029-05-30Target: 316Updated: 2026-07-06

A Study of Samuraciclib and Elacestrant in Participants With Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer

CompletedNCT05963997

Carrick Therapeutics LimitedBreast Cancer, Locally Advanced Breast Cancer, Metastatic Breast Cancer

Start: 2023-10-09End: 2026-03-06Updated: 2026-03-23

TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer. (Sub-Study C)

Active, not recruitingNCT06125522

PfizerBreast Cancer

Start: 2024-01-10End: 2026-12-31Updated: 2026-05-06

Samuraciclib for the Treatment of Patients With Resectable, Borderline Resectable, or Locally Advanced Basal Pancreatic Cancer

Not yet recruitingNCT07645651

University of WashingtonBorderline Resectable Pancreatic Ductal Adenocarcinoma, Locally Advanced Pancreatic Ductal Adenocarcinoma, Resectable Pancreatic Ductal Adenocarcinoma

Start: 2026-10-01End: 2027-11-01Target: 15Updated: 2026-07-13

Phase 2

A Study of Samuraciclib in Combination With Fulvestrant in Metastatic or Locally Advanced Breast Cancer in Adult Participants

CompletedNCT05963984

Carrick Therapeutics LimitedBreast Cancer, Locally Advanced Breast Cancer, Metastatic Breast Cancer

Start: 2023-11-16End: 2025-08-28Updated: 2025-12-26

Related Papers

Abstract PS1-08-06: Results of the phase 2 SUMIT-BC study, a randomized controlled trial of the cyclin-dependent kinase 7 inhibitor (CDK7i) samuraciclib with fulvestrant in advanced hormone receptor positive (HR+) breast cancer after a CDK4/6 inhibitor (CDK4/6i)

Clinical Cancer Research2026-02-17

Abstract P4-12-03: Vepdegestrant, a PROteolysis TArgeting Chimera (PROTAC) Estrogen Receptor (ER) Degrader, Plus Abemaciclib in ER-Pos/Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Advanced or Metastatic Breast Cancer: TACTIVE-U Prelim Phase 1b Results

Clinical Cancer Research2025-06-134 citations

Abstract P2-07-22: Cyclin-dependent kinase 7 (CDK7) inhibitor samuraciclib combined with selective estrogen receptor degrader (SERD) elacestrant in advanced HR+ breast cancer after CDK4/6i: dose escalation data from the Phase 1b/2 SUMIT-ELA study

Clinical Cancer Research2025-06-13

Giredestrant (G) with atezolizumab (ATEZO), and/or abemaciclib (ABEMA) in patients (pts) with ER+/HER2– locally advanced/metastatic breast cancer (LA/mBC): Interim analysis (IA) from the phase I/II MORPHEUS Breast Cancer study.

Journal of Clinical Oncology2025-05-281 citations

VERITAC-2: a Phase III study of vepdegestrant, a PROTAC ER degrader, versus fulvestrant in ER+/HER2- advanced breast cancer

Future Oncology2024-07-2965 citations

Fulvestrant with or without the cyclin-dependent kinase 7 (CDK7) inhibitor samuraciclib in advanced hormone receptor positive (HR+) breast cancer after CDK4/6 inhibition: Phase II SUMIT-BC study.

Journal of Clinical Oncology2024-06-013 citations

Interim analysis (IA) of the giredestrant (G) + everolimus (EVERO) arm in MORPHEUS Breast Cancer (BC): A phase I/II study of G treatment (tx) combinations in patients (pts) with estrogen receptor-positive (ER+), HER2-negative, locally advanced/metastatic BC (LA/mBC).

Journal of Clinical Oncology2024-06-011 citations

heredERA Breast Cancer: a phase III, randomized, open-label study evaluating the efficacy and safety of giredestrant plus the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in patients with previously untreated HER2-positive, estrogen receptor-positive locally advanced or metastatic breast cancer

BMC Cancer2024-05-246 citations

Abstract PS17-07: Interim analysis of giredestrant + inavolisib in MORPHEUS Breast Cancer: a Phase Ib/II study of giredestrant treatment combinations in estrogen receptor-positive, HER2-negative, locally advanced/metastatic breast cancer

Cancer Research2024-05-022 citations

Phase Ia/b Study of Giredestrant ± Palbociclib and ± Luteinizing Hormone-Releasing Hormone Agonists in Estrogen Receptor–Positive, HER2-Negative, Locally Advanced/Metastatic Breast Cancer

Clinical Cancer Research2023-11-0318 citations

Interim analyses (IA) of the giredestrant (G), G + abemaciclib (A), and G + ribociclib (R) arms in MORPHEUS Breast Cancer (BC): A phase I/II study of G treatment (tx) combinations in patients (pts) with estrogen receptor-positive, HER2-negative locally advanced/metastatic BC (ER+, HER2– LA/mBC).

Journal of Clinical Oncology2023-06-0110 citations