Phase 1/2 Study of HLD-0915 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
Halda Therapeutics OpCo, Inc.
Summary
Assessment of the safety and efficacy of HLD-0915 as monotherapy in patients with metastatic castration resistant prostate cancer (mCRPC) that have progressed on prior systemic therapies, once a recommended dose for expansion (RDE) has been determined in Phase 1 of the trial.
Description
This is a Phase 1/2, open-label study of the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and anti-tumor activity of oral single-agent HLD-0915. Patients on the study must continue androgen deprivation therapy (ADT) unless surgically castrated, The study will include an initial Phase 1 portion to determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDEs) of HLD-0915 as monotherapy and Phase 2 expansion cohorts to further evaluate the efficacy and safety of HLD-0915. Phase 1 of this study is an open-label, dose-escalation and cohort expansion…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Key Inclusion Criteria: All patients must meet the following criteria to be eligible for Phase 1 study participation: 1. Males of age 18 years at the time of signing the informed consent form (ICF). 2. Able to understand and voluntarily sign an informed consent document prior to any study-related assessments/procedures. 3. Patients must have histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate. 4. Patients must have prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone. 5. Patients must have progresse…
Interventions
- DrugHLD-0915
A treatment cycle consists of 21 days. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.)
Locations (11)
- Sarah Cannon Research Institute at HealthONEDenver, Colorado
- Yale - New Haven Hospital - Yale Cancer CenterNew Haven, Connecticut
- Florida Cancer SpecialistsSarasota, Florida
- Massachusetts General HospitalBoston, Massachusetts
- START Midwest, LLCGrand Rapids, Michigan
- Evelyn H. Lauder Breast and Imaging Center (BAIC)New York, New York