KTX-2001
/ K36 Therap
- LARVOL DELTA
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January 20, 2026
Phase 1, dose-escalation study of KTX-2001 (an NSD2 inhibitor) alone and in combination with darolutamide for metastatic castration-resistant prostate cancer.
(ASCO-GU 2026)
- P1 | "The sponsor's first in class NSD2 inhibitor, KTX-1001, was shown to be tolerable and have preliminary efficacy in patients with relapsed/refractory multiple myeloma (5). Li J, bioRxiv 2023.07.18.549585 5. Bories P, Blood Vol 144, Suppl 1,2024."
Combination therapy • Metastases • P1 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • AR • CTCs • NSD2
February 24, 2026
K36 Therapeutics Highlights First-in-Human KTX-2001 Prostate Cancer Study Design at American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium 2026
(PRNewswire)
- "The KTX-2001 Trial in Progress poster will highlight the scientific rationale, study design, patient population, and dose-escalation study of the first-in-human Phase 1 STRIKE-001 trial. Part A is designed to evaluate the safety, tolerability, maximum tolerated dose, and recommended Phase 2 dose(s) of KTX-2001 monotherapy. Part B will evaluate the safety and tolerability of KTX-2001 plus darolutamide to determine the recommended Phase 2 dose(s) for the combination."
Clinical protocol • First-in-human • Castration-Resistant Prostate Cancer
February 05, 2026
K36 Therapeutics…announced completion of dosing in the first patient cohort of its Phase 1 clinical trial evaluating KTX-2001, a first-in-class, orally administered, selective NSD2 inhibitor, in patients with metastatic castration-resistant prostate cancer (mCRPC)
(PRNewswire)
- "The Phase 1 clinical trial, STRIKE-001 (NCT07103018), is a multi-center, open-label dose escalation of KTX-2001 monotherapy (Part A) and in combination with darolutamide, an oral, nonsteroidal androgen receptor inhibitor (Part B)."
Trial status • Castration-Resistant Prostate Cancer
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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