Study of HLD-0915 in Patients With Metastatic Prostate Cancer

NCT06800313 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: HLD-0915-ONC-101
• Study Type: interventional
• Target: 190
• Locations: 2 countries
• Sites: 12

Brief Summary

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.

Conditions

Metastatic Prostate Cancer

Keywords

Prostate Cancer; RIPTAC; HLD-0915; Genital Neoplasms, Male; Urogenital Neoplasms, Male; Genital Diseases, Male; Urogenital Diseases, Male; Neoplasms, Glandular and Epithelial; Prostatic Neoplasms; Prostate Adenocarcinoma; Hormone Sensitive, Castrate Resistant; Metastatic Castrate Resistant Prostate Cancer

Outcome Measures

Primary Outcomes (3)

• Frequency of dose-limiting toxicities (DLTs)

  21 days

• Frequency and severity of AEs and abnormal ECG, laboratory and clinical changes since baseline

  21 days

• Phase 1 Part 2 (formulation exploration) relative bioavailability

  22 days

Secondary Outcomes (6)

• PK Parameters

  21 days

• Change in PSA over time

  21 days

• Objective Response Rate (ORR)

  63 days

• Duration of Response (DOR)

  21 days

• Radiographic Progression-Free Survival (rPFS)

  63 days

Study Arms (7)

HLD-0915 Phase 1 Part 1 - Dose Escalation

EXPERIMENTAL

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.)

Drug: HLD-0915 Hard Capsule

HLD-0915 Phase 1 Part 2 - Formulation Exploration

EXPERIMENTAL

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.)

Drug: HLD-0915 Hard Capsule; Drug: HLD-0915 Tablet; Drug: HLD-0915 Soft Capsule

HLD-0915 Phase 2 Part 1 - Dose Optimization

EXPERIMENTAL

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.)

Drug: HLD-0915 Hard Capsule

Phase 2 Part 2A - SOAR

EXPERIMENTAL

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.)

Drug: HLD-0915 Hard Capsule

Phase 2 Part 2B - HSPC Expansion

EXPERIMENTAL

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.)

Drug: HLD-0915 Hard Capsule

Phase 2 Part 2C - HSPC Expansion

EXPERIMENTAL

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.)

Drug: HLD-0915 Hard Capsule

Phase 2 Part 2D - HSPC Expansion

EXPERIMENTAL

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.)

Drug: HLD-0915 Hard Capsule

Interventions

HLD-0915 Hard Capsule DRUG

Experimental: Oral HLD-0915

HLD-0915 Phase 1 Part 1 - Dose Escalation; HLD-0915 Phase 1 Part 2 - Formulation Exploration; HLD-0915 Phase 2 Part 1 - Dose Optimization; Phase 2 Part 2A - SOAR; Phase 2 Part 2B - HSPC Expansion; Phase 2 Part 2C - HSPC Expansion; Phase 2 Part 2D - HSPC Expansion

HLD-0915 Tablet DRUG

Experimental: Oral HLD-0915

HLD-0915 Phase 1 Part 2 - Formulation Exploration

HLD-0915 Soft Capsule DRUG

Experimental: Oral HLD-0915

HLD-0915 Phase 1 Part 2 - Formulation Exploration

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify 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 histopathology Receiving continuous corticosteroids at prednisone-equivalent dose of \>10 mg/day Prior or ongoing significant medical condition
• 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 periods
• 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

Sponsors & Collaborators

• Halda Therapeutics OpCo, Inc.: lead

Study Sites (12)

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, 80218, United States

RECRUITING

Yale - New Haven Hospital - Yale Cancer Center

New Haven, Connecticut, 06520, United States

RECRUITING

Florida Cancer Specialists

Sarasota, Florida, 34232, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

START Midwest, LLC

Grand Rapids, Michigan, 49546, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

Carolina Urologic Research Center, LLC

Myrtle Beach, South Carolina, 29572, United States

RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

NEXT Austin

Austin, Texas, 78758, United States

RECRUITING

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Royal Marsden Hospital

Sutton, Surrey, SM2 5PT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Male Urogenital Diseases; Neoplasms, Glandular and Epithelial

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type

Central Study Contacts

Study Information

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This multi-phase, multi-part study evaluates safety, PK, and preliminary efficacy of HLD-0915 across mPC disease states, while supporting dose selection and formulation development. Phase 1: Part 1 (Dose Escalation) uses a BF-BOIN design to identify the MTD and RDE. This adaptive approach allows enrollment at doses already shown to be safe, generating additional safety, tolerability, and early activity data to inform dose selection. Part 2 (Formulation Exploration) evaluates the relative bioavailability of new HLD-0915 formulations at doses demonstrated to be safe. Phase 2: Part 1 (Dose Optimization) evaluates anti-tumor activity at different randomized RDE(s) while continuing to assess safety and PK. Part 2 (Parts 2A,2B,2C,2D) Expansion Cohorts assesses safety and early efficacy at the RDE (or highest dose deemed safe) in defined metastatic HSPC populations. The design aims to establish dose and formulation and to characterize therapeutic potential across mPC populations.

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: January 30, 2025
• Study Start: February 20, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2030
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); US (11)