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New treatment option for Metastatic Prostate Cancer
Official title Study of HLD-0915 in Patients With Metastatic Prostate Cancer
ClinicalTrials.gov ID: NCT06800313
What this study is testing
What is HLD-0915 Hard Capsule?
HLD-0915 Hard Capsule is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for metastatic prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Assessment of the safety and efficacy of HLD-0915 in patients with metastatic prostate cancer who have progressed on prior systemic therapies, with further evaluation in additional prostate cancer populations.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Patients must meet the following criteria to be eligible study participation:
- All Study Arms (Phase 1 Part 1 \& 2, Phase 2 Part 1, Part 2A, 2B, 2C \& 2D):
- Males ≥ 18 years old Histological, pathological, and/or cytological confirmation of prostate adenocarcinoma Adequate hematological, renal, and...
- mCRPC Arms: (Phase 1 Part 1 \& 2, Phase 2 Part 1): Prior orchiectomy or ongoing androgen-deprivation therapy and a castrate level of serum...
- SOAR Arm (Phase 2 Part 2A) mHSPC with distant metastatic disease based on conventional imaging PSA ≥0.2 ng/mL, following treatment with next...
You likely can't join if
- All arms (Phase 1 Part 1 \& 2, Phase 2 Part 1, Part 2A, 2B, 2C \& 2D):
- Has experienced a recent major bleed or has a known bleeding disorder Tumors exhibiting neuroendocrine or small cell carcinoma component by...
- mCRPC arms: (Phase 1 Part 1 \& 2, Phase 2 Part 1): Has received systemic anti-cancer therapy or investigational drugs within 2 weeks prior to first...
- SOAR arm (Phase 2 Part 2A) Has received any prior cytotoxic chemotherapy for prostate cancer
- mHSPC arms (Phase 2 Part 2B, 2C \& 2D) regional pelvic lymph node disease only
See the full eligibility criteria
- Patients must meet the following criteria to be eligible study participation:
- All Study Arms (Phase 1 Part 1 \& 2, Phase 2 Part 1, Part 2A, 2B, 2C \& 2D):
- Males ≥ 18 years old Histological, pathological, and/or cytological confirmation of prostate adenocarcinoma Adequate hematological, renal, and hepatic function. Able to swallow oral medication
- mCRPC Arms: (Phase 1 Part 1 \& 2, Phase 2 Part 1): Prior orchiectomy or ongoing androgen-deprivation therapy and a castrate level of serum testosterone Progressive mCRPC defined as having demonstrated PSA progression on...
- SOAR Arm (Phase 2 Part 2A) mHSPC with distant metastatic disease based on conventional imaging PSA ≥0.2 ng/mL, following treatment with next generation ARPI for at least 180 days and up to 365 days No evidence of...
- mHSPC arms (Phase 2 Part 2B, 2C \& 2D) serum testosterone \>150ng/ml mHSPC with distant metastatic disease based on conventional imaging and PSA \>2.0 ng/mL
- All arms (Phase 1 Part 1 \& 2, Phase 2 Part 1, Part 2A, 2B, 2C \& 2D):
- Has experienced a recent major bleed or has a known bleeding disorder Tumors exhibiting neuroendocrine or small cell carcinoma component by histopathology Receiving continuous corticosteroids at prednisone-equivalent...
- mCRPC arms: (Phase 1 Part 1 \& 2, Phase 2 Part 1): Has received systemic anti-cancer therapy or investigational drugs within 2 weeks prior to first dose of study drug with certain exceptions requiring longer washout...
- SOAR arm (Phase 2 Part 2A) Has received any prior cytotoxic chemotherapy for prostate cancer
- mHSPC arms (Phase 2 Part 2B, 2C \& 2D) regional pelvic lymph node disease only
The study team makes the final eligibility decision.
Where it's taking place
- Denver, Colorado, United States
- New Haven, Connecticut, United States
- Sarasota, Florida, United States
- Boston, Massachusetts, United States
- Grand Rapids, Michigan, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Myrtle Beach, South Carolina, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- Houston, Texas, United States
- Sutton, Surrey, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Denver, Colorado, United States; New Haven, Connecticut, United States; Sarasota, Florida, United States; Boston, Massachusetts, United States; Grand Rapids, Michigan, United States; New York, New York, United States and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.