Phase 1/2 Study of HLD-0915 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

‣ 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.

Locations
United States
Colorado
Sarah Cannon Research Institute at HealthONE
RECRUITING
Denver
Florida
Florida Cancer Specialists
RECRUITING
Sarasota
Michigan
START Midwest, LLC
RECRUITING
Grand Rapids
Tennessee
SCRI Oncology Partners
RECRUITING
Nashville
Texas
NEXT Austin
RECRUITING
Austin
The University of Texas M.D. Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Medical Monitor
ProstateClinicalTrial@haldathera.com
475-210-0212
Time Frame
Start Date: 2025-02-24
Estimated Completion Date: 2027-03
Participants
Target number of participants: 33
Treatments
Experimental: HLD-0915
Oral HLD-0915 administered as a single agent on a 21-day treatment cycle.
Related Therapeutic Areas
Sponsors
Leads: Halda Therapeutics OpCo, Inc.

This content was sourced from clinicaltrials.gov