Actively Recruiting
A Study of HLD-0915 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
Led by Halda Therapeutics OpCo, Inc. · Updated on 2025-10-16
33
Participants Needed
11
Research Sites
105 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of HLD-0915 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged 18 years or older at the time of consent
- Able to understand and voluntarily sign informed consent
- Histological, pathological, or cytological confirmation of prostate adenocarcinoma
- Prior orchiectomy and/or ongoing androgen-deprivation therapy with castrate serum testosterone levels
- Progressed on prior line(s) of therapy
- Progressive metastatic castration-resistant prostate cancer with PSA progression
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Adequate blood, kidney, and liver function
- Able to swallow oral medication
- Willing and able to follow study visit schedule and protocol
- Stable bisphosphonate or denosumab treatment for at least 30 days before enrollment
You will not qualify if you...
- Recent major bleed or known bleeding disorder
- Tumors with neuroendocrine or small cell carcinoma features
- Receiving continuous corticosteroids at prednisone-equivalent dose greater than 10 mg/day
- Received systemic anti-cancer therapy or investigational drugs within 2 weeks before first study dose (with some exceptions)
- History of myocardial infarction or unstable angina within 6 months, or significant cardiac disease
- Known active or chronic infection of clinical significance
- Acute or chronic uncontrolled kidney disease, pancreatitis, or liver disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States, 80218
Actively Recruiting
2
Yale - New Haven Hospital - Yale Cancer Center
New Haven, Connecticut, United States, 06520
Actively Recruiting
3
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
Actively Recruiting
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
5
START Midwest, LLC
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
6
Evelyn H. Lauder Breast and Imaging Center (BAIC)
New York, New York, United States, 10065
Actively Recruiting
7
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
8
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
9
NEXT Austin
Austin, Texas, United States, 78758
Actively Recruiting
10
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
11
Royal Marsden Hospital
Sutton, Surrey, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
M
Medical Monitor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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