A Study of HLD-0915 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
NCT ID: NCT06800313
Last Updated: 2025-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
33 participants
INTERVENTIONAL
2025-02-24
2027-03-31
Brief Summary
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Detailed Description
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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 study in patients with mCRPC that have progressed after prior systemic therapies. Patients will be enrolled in monotherapy dose-escalation cohorts using a Bayesian optimal interval with backfill (BF-BOIN) design. Patients are treated in cohort size of 3 with the enrollment staggered between cohorts.
Phase 2 of this study will evaluate the anti-tumor activity of HLD-0915 administered at the RDEs in patients with mCRPC. Phase 2 study design and patient population will be based on the outcomes of Phase 1 of the trial.
Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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HLD-0915
Oral HLD-0915 administered as a single agent on a 21-day treatment cycle.
HLD-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.)
Interventions
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HLD-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.)
Eligibility Criteria
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Inclusion Criteria
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 progressed on prior line(s) of therapy.
6. 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.
7. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
8. Life expectancy of at least 3 months.
9. Adequate hematological, renal, and hepatic function.
10. Able to swallow an oral medication.
11. Willing and able to adhere to the study visit schedule and other protocol requirements.
12. Patients on a stable bisphosphonate or denosumab regimen for 30 days prior to enrollment are eligible.
Exclusion Criteria
1. Has experienced a recent major bleed or has a known bleeding disorder.
2. Tumors exhibiting neuroendocrine or small cell carcinoma component by histopathology.
3. Receiving continuous corticosteroids at prednisone-equivalent dose of \>10 mg/day.
4. 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.
5. History of myocardial infarction or unstable angina within 6 months prior to enrollment, or clinically significant cardiac disease.
6. Known clinically significant active or chronic infection.
7. Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease.
18 Years
MALE
No
Sponsors
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Halda Therapeutics OpCo, Inc.
INDUSTRY
Responsible Party
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Locations
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Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States
Yale - New Haven Hospital - Yale Cancer Center
New Haven, Connecticut, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
START Midwest, LLC
Grand Rapids, Michigan, United States
Evelyn H. Lauder Breast and Imaging Center (BAIC)
New York, New York, United States
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
NEXT Austin
Austin, Texas, United States
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
Royal Marsden Hospital
Sutton, Surrey, United Kingdom
Countries
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Central Contacts
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Other Identifiers
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HLD-0915-ONC-101
Identifier Type: -
Identifier Source: org_study_id
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