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A Study of HLD-0915 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
NCT06800313 · Halda Therapeutics OpCo, Inc.
In plain English
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Official title
Phase 1/2 Study of HLD-0915 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
About this study
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 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.
Eligibility criteria
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 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.
Key Exclusion Criteria:
Patients with any of the following will be excluded from participation in Phase 1 of the study:
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.
Study design
Enrollment target: 33 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-02-24
Estimated completion: 2027-03
Last updated: 2025-10-16
Interventions
Drug: HLD-0915
Primary outcomes
- • 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)
Sponsor
Halda Therapeutics OpCo, Inc. · industry
Contacts & investigators
ContactMedical Monitor · contact · ProstateClinicalTrial@haldathera.com · 475-273-6214
All locations (11)
Sarah Cannon Research Institute at HealthONERecruiting
Denver, Colorado, United States
Yale - New Haven Hospital - Yale Cancer CenterRecruiting
New Haven, Connecticut, United States
Florida Cancer SpecialistsRecruiting
Sarasota, Florida, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
START Midwest, LLCRecruiting
Grand Rapids, Michigan, United States
Evelyn H. Lauder Breast and Imaging Center (BAIC)Recruiting
New York, New York, United States
Carolina Urologic Research Center, LLCRecruiting
Myrtle Beach, South Carolina, United States
SCRI Oncology PartnersRecruiting
Nashville, Tennessee, United States
NEXT AustinRecruiting
Austin, Texas, United States
The University of Texas M.D. Anderson Cancer CenterRecruiting
Houston, Texas, United States
Royal Marsden HospitalRecruiting
Sutton, Surrey, United Kingdom