ClinicaliQ Trial Snapshot
- Study of HLD-0915 in Patients With Metastatic Prostate Cancer — Recruiting • Phase I • Oncology • NCT06800313.
- Drug and indication: HLD-0915 is being tested for safety and efficacy in metastatic prostate cancer patients who have failed previous systemic treatments, with planned expansion to additional prostate cancer populations.
- Patient eligibility: Study targets heavily pretreated patients with metastatic disease who have progressed despite prior systemic therapy, representing a population with limited treatment options.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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.
Eligibility Snapshot
- Patients must meet the following criteria to be eligible study participation: Key Inclusion Criteria: 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 the prior regimen 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 radiographic or PSA progression while receiving ARPI 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 Key
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.