K36 Therapeutics Highlights First-in-Human KTX-2001 Prostate Cancer Study Design at American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium 2026

KTX-2001 is being evaluated in the Phase 1 STRIKE-001 clinical trial both as a monotherapy and in combination with darolutamide in metastatic castration-resistant prostate cancer (mCRPC)

CAMBRIDGE, Mass., Feb. 24, 2026 /PRNewswire/ -- K36 Therapeutics, Inc. ("K36"), a privately held, clinical-stage biotechnology company developing novel targeted therapies for cancers with high unmet medical need, today announced data from its Phase 1 clinical trial of KTX-2001 will be presented in a Trial in Progress poster at the ASCO Genitourinary Cancers Symposium, taking place February 26–28, 2026, in San Francisco, California. KTX-2001 is a first-in-class, orally administered, selective NSD2 inhibitor being evaluated in patients with metastatic castration-resistant prostate cancer (mCRPC) and represents the company's second NSD2 inhibitor to enter clinical development.

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. Secondary objectives include assessments of pharmacokinetics, pharmacodynamics, and preliminary clinical activity.

"We are pleased to present the STRIKE-001 study design evaluating KTX-2001, an oral, first-in-class NSD2/MMSET inhibitor, in metastatic castration-resistant prostate cancer," said Wassim Abida, MD, PhD, of Memorial Sloan Kettering Cancer Center. "Preclinical findings support the rationale for targeting NSD2 in prostate cancer, where it has been associated with lineage plasticity, resistance to androgen receptor pathway inhibitors, and progression to treatment-emergent neuroendocrine disease. STRIKE-001 is designed to assess the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of KTX-2001 as monotherapy and in combination with darolutamide in this setting."

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).

ASCO Genitourinary Cancers Symposium, February 26–28, 2026 
Trial in Progress Poster Details:

Title: Phase 1, dose-escalation study of KTX-2001 (an NSD2 inhibitor) alone and in combination with darolutamide for metastatic castration-resistant prostate cancer
Abstract Number: TPS276                                                               
Poster Number: N12
Session Title: Trials in Progress Poster Session A: Prostate Cancer
Presentation Time: February 26, 2026, 11:30 AM-12:45 PM; 5:45 PM-6:45 PM (PST)
Location -Moscone Center (West), San Francisco
Full abstract can be found at ASCO GU Meeting Website: https://asco.org/abstracts-presentations/256624

About the KTX-2001 Phase 1 Clinical Trial (STRIKE-001)
STRIKE-001 (NCT07103018) is a multi-center, open-label dose escalation evaluating KTX-2001 as a monotherapy (Part A) and in combination with darolutamide (Part B). K36 expects to enroll approximately 140 patients with mCRPC who have received prior androgen receptor inhibitors and prior chemotherapy.

KTX-2001 is a small molecule, selective inhibitor of nuclear receptor binding SET domain protein 2 (NSD2, also known as multiple myeloma [MM] SET domain-containing protein [MMSET]/Wolf-Hirschhorn syndrome candidate 1 protein [WHSC1]). KTX-2001 inhibits NSD2-mediated dimethylation of histone H3 at lysine 36 (H3K36me2), disrupting aberrant NSD2-dependent oncogenic pathways.

About K36 Therapeutics, Inc.
Founded in February 2021, K36 Therapeutics is a privately held biotechnology company backed by Atlas Venture, F-Prime, Eight Roads Ventures, Nextech and Bristol Myers Squibb. Our mission is to translate epigenetic modulation of oncogenic pathways into first-in-class small molecule therapeutics for the benefit of cancer patients worldwide. For more information, please visit www.k36tx.com and follow us on LinkedIn.

Contacts:

K36 Therapeutics
Soo Bang
[email protected] 

Media
Sarah Sutton
[email protected]    

SOURCE K36 Therapeutics