On February 24, 2026 K36 Therapeutics, Inc. ("K36"), a privately held, clinical-stage biotechnology company developing novel targeted therapies for cancers with high unmet medical need, reported data from its Phase 1 clinical trial of KTX-2001 will be presented in a Trial in Progress poster at the ASCO (Free ASCO Whitepaper) 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.
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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 (Free ASCO Whitepaper) GU Meeting Website: View Source
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.
(Press release, K36 Therapeutics, FEB 24, 2026, View Source [SID1234662947])