Actively Recruiting
Phase 1/2 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of an oral drug called HLD-0915 in patients with metastatic castration resistant prostate cancer (mCRPC) who have already undergone prior systemic therapies. This Phase 1/2 open-label study aims to identify a recommended dose for expansion and to further assess the drug's effects in patients who continue androgen deprivation therapy or have had surgical castration. The study consists of two parts: Phase 1 involves dose-escalation cohorts to determine the maximum tolerated dose and recommended dose for expansion of HLD-0915 given as a single oral agent in 21-day treatment cycles. Phase 2 will expand on these findings by evaluating the drug's anti-tumor activity at the recommended dose. Treatment may continue until disease progression or other reasons such as withdrawal or unacceptable side effects. Participants will undergo regular safety and efficacy assessments including monitoring for dose-limiting toxicities, adverse events, blood tests, ECGs, and prostate-specific antigen (PSA) levels. Pharmacokinetic measures such as plasma drug concentrations and response durations will be tracked. The study includes ongoing evaluations of tumor response and progression, with study involvement lasting as long as treatment continues without unacceptable effects or disease progression.
CONDITIONS
Brief 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 patients aged 18 years or older
- Able to understand and voluntarily sign informed consent
- Histological, pathological, and/or cytological confirmation of prostate adenocarcinoma
- Prior orchiectomy and/or ongoing androgen deprivation therapy with castrate serum testosterone level
- 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 hematological, renal, and hepatic function
- Able to swallow oral medication
- Willing and able to adhere to study visit schedule and protocol requirements
- On stable bisphosphonate or denosumab regimen for at least 30 days prior to enrollment
You will not qualify if you...
- Recent major bleeding event or known bleeding disorder
- Tumors with neuroendocrine or small cell carcinoma component
- Receiving continuous corticosteroids equivalent to prednisone >10 mg/day
- Received systemic anti-cancer therapy or investigational drugs within 2 weeks prior to study drug with some exceptions
- History of myocardial infarction or unstable angina within 6 months, or significant cardiac disease
- Known clinically significant active or chronic infection
- Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Multiple 21-day cycles until disease progression or discontinuation
Participants receive oral HLD-0915 as a single agent in 21-day treatment cycles. Treatment may continue until disease progression or study discontinuation due to consent withdrawal, illness, adverse events, or other reasons.
Visits occur each treatment cycle; frequency determined by treatment schedule
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
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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