A Study of HLD-0915 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
Phase 1/2 Study of HLD-0915 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
1 other identifier
interventional
33
2 countries
11
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2025
Typical duration for phase_1
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2025
CompletedFirst Posted
Study publicly available on registry
January 30, 2025
CompletedStudy Start
First participant enrolled
February 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
October 16, 2025
October 1, 2025
2 years
January 20, 2025
October 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Phase 1: Frequency of dose-limiting toxicities (DLTs)
21 days
Phase 1: Frequency and severity of AEs and serious adverse events (SAEs), including abnormal clinical observations, abnormal ECG parameters, abnormal laboratory assessments and abnormal vital signs changed from baseline
21 days
Secondary Outcomes (11)
Phase 1: Plasma concentrations of HLD-0915 as a function of time post-dosing
21 days
Phase 1: Plasma PK Parameters (Cmax)
21 days
Phase 1: Plasma PK Parameters (Tmax)
21 days
Phase 1: Plasma PK Parameters (T1/2)
21 days
Phase 1: Plasma PK Parameters (AUC0-inf)
21 days
- +6 more secondary outcomes
Study Arms (1)
HLD-0915
EXPERIMENTALOral HLD-0915 administered as a single agent on a 21-day treatment cycle.
Interventions
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.)
Eligibility Criteria
You may qualify if:
- All patients must meet the following criteria to be eligible for Phase 1 study participation:
- Males of age 18 years at the time of signing the informed consent form (ICF).
- Able to understand and voluntarily sign an informed consent document prior to any study-related assessments/procedures.
- Patients must have histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate.
- Patients must have prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone.
- Patients must have progressed on prior line(s) of therapy.
- Patients must have progressive mCRPC defined as having demonstrated PSA progression on the prior regimen. PSA progression may have occurred with or without accompanying radiographic progression.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Life expectancy of at least 3 months.
- Adequate hematological, renal, and hepatic function.
- Able to swallow an oral medication.
- Willing and able to adhere to the study visit schedule and other protocol requirements.
- Patients on a stable bisphosphonate or denosumab regimen for 30 days prior to enrollment are eligible.
You may not qualify if:
- Patients with any of the following will be excluded from participation in Phase 1 of the study:
- Has experienced a recent major bleed or has a known bleeding disorder.
- Tumors exhibiting neuroendocrine or small cell carcinoma component by histopathology.
- Receiving continuous corticosteroids at prednisone-equivalent dose of \>10 mg/day.
- Has received systemic anti-cancer therapy (cytotoxic chemotherapy, biologic agent, checkpoint inhibitors, or radiation therapy) or investigational drugs within 2 weeks prior to first dose of study drug with certain exceptions requiring longer washout periods.
- History of myocardial infarction or unstable angina within 6 months prior to enrollment, or clinically significant cardiac disease.
- Known clinically significant active or chronic infection.
- Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218, United States
Yale - New Haven Hospital - Yale Cancer Center
New Haven, Connecticut, 06520, United States
Florida Cancer Specialists
Sarasota, Florida, 34232, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
START Midwest, LLC
Grand Rapids, Michigan, 49546, United States
Evelyn H. Lauder Breast and Imaging Center (BAIC)
New York, New York, 10065, United States
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina, 29572, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
NEXT Austin
Austin, Texas, 78758, United States
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Royal Marsden Hospital
Sutton, Surrey, SM2 5PT, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2025
First Posted
January 30, 2025
Study Start
February 24, 2025
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
October 16, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share