KTX-2001
/ K36 Therap
- LARVOL DELTA
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October 16, 2025
A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)
(clinicaltrials.gov)
- P1 | N=144 | Recruiting | Sponsor: K36 Therapeutics, Inc. | Not yet recruiting ➔ Recruiting
Enrollment open • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor
August 07, 2025
K36 Therapeutics Receives FDA Clearance of Investigational New Drug (IND) Application for KTX-2001 in Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Announces Clinical Trial Collaboration with Bayer for Supply of Darolutamide
(PRNewswire)
- "K36 Therapeutics...announced the US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) Application for KTX-2001...With this clearance, KTX-2001 becomes the second NSD2 inhibitor from K36 to advance into clinical development. This Phase 1 program will evaluate KTX-2001 both as a monotherapy and in combination with Bayer's androgen receptor inhibitor, darolutamide, for metastatic castration-resistant prostate cancer (mCRPC) NCT07103018....'Along with this significant milestone, I am delighted to announce the Company has entered into a clinical trial collaboration agreement with Bayer for supply of darolutamide for the combination with KTX-2001 in our trial.'....Separately, K36 announced it has selected the Prostate Cancer Clinical Trials Consortium (PCCTC) as the Contract Research Organization (CRO) who will operationalize the KTX-2001 clinical program, STRIKE-001."
Commercial • IND • Trial status • Castration-Resistant Prostate Cancer
August 06, 2025
A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)
(clinicaltrials.gov)
- P1 | N=144 | Not yet recruiting | Sponsor: K36 Therapeutics, Inc.
New P1 trial • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor
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