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Pidnarulex

DRUG5 trials

Sponsors

Peter MacCallum Cancer Centre, Australia, National Cancer Institute (NCI)

Conditions

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8Burkitt LymphomaDouble-Expressor LymphomaHigh Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 RearrangementsInvasive Breast CarcinomaLocally Advanced Breast CarcinomaMetastatic Breast Carcinoma

Phase 1

Pidnarulex and Talazoparib in Patients With Metastatic Castration Resistant Prostate Cancer
SuspendedNCT05425862
Peter MacCallum Cancer Centre, AustraliaMetastatic Castration Resistant Prostate Cancer (mCRPC)
Start: 2022-10-21End: 2025-12-30Target: 48Updated: 2023-12-11
Testing How the Body Responds to the Drug CX-5461 (Pidnarulex) in Patients With Metastatic Solid Cancers
RecruitingNCT06606990
National Cancer Institute (NCI)Metastatic Malignant Solid Neoplasm
Start: 2025-07-01End: 2026-12-31Target: 40Updated: 2026-04-03
Testing the Safety of Anti-Cancer Drug, CX-5461 (Pidnarulex), in Treating Lymphoma With Specific Changes in the MYC Gene
RecruitingNCT07069699
National Cancer Institute (NCI)Burkitt Lymphoma, Double-Expressor Lymphoma, High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements
Start: 2026-10-13End: 2030-01-31Target: 50Updated: 2026-04-03
Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Solid Tumors and Breast Cancer
RecruitingNCT07137416
National Cancer Institute (NCI)Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma +13
Start: 2026-10-05End: 2028-01-10Target: 36Updated: 2026-04-03
Testing the Effectiveness of the Anti-cancer Drug Pidnarulex (CX-5461) in Combination With Another Anti-cancer Drug Cemiplimab (REGN2810), in Treating Refractory Microsatellite Stable Colorectal Cancer
Not yet recruitingNCT07147231
National Cancer Institute (NCI)Metastatic Colorectal Adenocarcinoma, Refractory Colorectal Adenocarcinoma, Stage III Colorectal Cancer AJCC v8 +2
Start: 2026-03-31End: 2027-09-30Target: 86Updated: 2026-03-27

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