Study of HLD-0915 in Patients With Metastatic Prostate Cancer

Conditions

• Metastatic Prostate Cancer

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• HLD-0915 Hard Capsule — DRUG
  Experimental: Oral HLD-0915
• HLD-0915 Tablet — DRUG
  Experimental: Oral HLD-0915
• HLD-0915 Soft Capsule — DRUG
  Experimental: Oral HLD-0915

Study Details

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.

Key Dates

First listed

Jan 30, 2025

Start date

Feb 20, 2025

Status verified

Jun 2026

Primary completion

Apr 30, 2028

Completion

Apr 30, 2030

Study Design

Enrollment

190 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: HLD-0915 Phase 1 Part 1 - Dose Escalation
  Treatment cycle consists of 21 days. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.)
• Experimental: HLD-0915 Phase 1 Part 2 - Formulation Exploration
  Hard capsule: Single 50mg dose Tablet: Single 50mg dose, followed by daily dosing through Cycle 2. Soft capsule: 50mg daily in 21-day treatment cycles. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.)
• Experimental: HLD-0915 Phase 2 Part 1 - Dose Optimization
  Hard Capsules 25mg or 50 mg Treatment cycle consists of 21 days. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.)
• Experimental: Phase 2 Part 2A - SOAR
  Hard Capsules Treatment cycle consists of 21 days. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.)
• Experimental: Phase 2 Part 2B - HSPC Expansion
  Hard Capsules Treatment cycle consists of 21 days. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.)
• Experimental: Phase 2 Part 2C - HSPC Expansion
  Hard capsules Treatment cycle consists of 21 days. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.)
• Experimental: Phase 2 Part 2D - HSPC Expansion
  HLD-0915 Hard Capsules Treatment cycle consists of 21 days. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.)

Primary Outcome Measure

Frequency of dose-limiting toxicities (DLTs) [ Time Frame: 21 days ]

Central Contacts

• Study Information
  844-434-4210
  [email protected]

Locations (11)

Find similar trials in Denver, CO

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