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OncoMatch/Clinical Trials/NCT06800313

Study of HLD-0915 in Patients With Metastatic Prostate Cancer

Is NCT06800313 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies multiple treatments including HLD-0915 Hard Capsule and HLD-0915 Tablet for metastatic prostate cancer.

Phase 1/2RecruitingHalda Therapeutics OpCo, Inc.NCT06800313Data as of Sep 2026Location: United States · United Kingdom

Treatment: HLD-0915 Hard Capsule · HLD-0915 Tablet · HLD-0915 Soft CapsuleAssessment 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.

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Extracted eligibility criteria

Treatments studied

Other

HLD-0915 Hard CapsuleHLD-0915 TabletHLD-0915 Soft Capsule

Cancer type

Prostate Cancer

Disease stage

Required: Stage IV

Metastatic disease required

metastatic prostate cancer

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Male only

Prior therapy

Must have received: androgen-deprivation therapy — mCRPC

Prior orchiectomy or ongoing androgen-deprivation therapy and a castrate level of serum testosterone

Must have received: androgen receptor pathway inhibitor — mHSPC

treatment with next generation ARPI for at least 180 days and up to 365 days

Cannot have received: cytotoxic chemotherapy for prostate cancer

Has received any prior cytotoxic chemotherapy for prostate cancer

Lab requirements

Blood counts

Kidney function

Liver function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Sarah Cannon Research Institute at HealthONE · Denver, Colorado
  • Yale - New Haven Hospital - Yale Cancer Center · New Haven, Connecticut
  • Florida Cancer Specialists · Sarasota, Florida
  • Massachusetts General Hospital · Boston, Massachusetts
  • START Midwest, LLC · Grand Rapids, Michigan

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT06800313 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior cytotoxic chemotherapy for prostate cancer disqualifies patients from enrollment.

What disease stage is eligible?

Stage IV is required (metastatic disease required).

Is this trial open to female patients?

No. This trial enrolls male patients only.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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