KTX-2001 / K36 Therap - LARVOL DELTA

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

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

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

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

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

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