Phase 1, Dose-Escalation Study of KTX2001 (an NSD2 Inhibitor) Alone and in Combination With Darolutamide for Metastatic Castration-Resistant Prostate Cancer
K36 Therapeutics, Inc.
Summary
Study K36-MCRPC-001 is the first in human clinical trial testing KTX-2001 alone and with darolutamide in men with metastatic castration-resistant prostate cancer. The study aims to assess whether the drug is safe, increasing doses alone and in combination with darolutamide, whether it is effective in treating metastatic castration-resistant prostate cancer, and measuring how the drug(s) behaves in the body.
Description
Study K36-MCRPC-001 (also know as K36-STRIKE-001) is a multicenter, open-label Phase 1 study for participants with metastatic castration-resistant prostate cancer (mCRPC) to investigate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of KTX-2001 monotherapy and KTX-2001 in combination with darolutamide (NUBEQA®), and to establish a recommended Phase 2 dose(s) of KTX-2001 for future study.
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥18 years. 2. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1. 3. Male participants with mCRPC as defined by PCWG3 criteria. 4. Metastatic disease documented using bone scan for bone metastases (PCWG3 criteria) or by computed tomography (CT) or magnetic resonance imaging (MRI) for soft-tissue metastases. Evidence of metastasis on prostate-specific membrane antigen positron emission tomography alone will not be sufficient for confirmation of metastatic disease. 5. Willingness to undergo a baseline and on-treatment biopsy of a metastatic site if safe and fea…
Interventions
- DrugKTX-2001
Participants will receive escalating doses of KTX-2001 monotherapy
- DrugKTX-2001 + Darolutamide (NUBEQA®)
Participants will receive escalating doses of KTX-2001, in combination with the oral androgen receptor (AR) pathway inhibitor (ARPI), darolutamide (NUBEQA®)
Locations (13)
- University of California San FranciscoSan Francisco, California
- Sylvester Comprehensive Cancer CenterMiami, Florida
- Hematology Oncology Associates of the Treasure CoastPort Saint Lucie, Florida
- Mayo ClinicRochester, Minnesota
- START New York Long Island, LLCNew Hyde Park, New York
- NYU Langone HealthNew York, New York