Study of HLD-0915 in Patients With Metastatic Prostate Cancer

June 24, 2026 updated by: Halda Therapeutics OpCo, Inc.

Phase 1/2 Study of HLD-0915 (JNJ-101556143) in Patients With Metastatic Prostate Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a Phase 1/2 study of the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and anti-tumor activity of oral single-agent HLD-0915.

The study includes an initial Phase 1 open-label portion to determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDEs) of HLD-0915 as monotherapy, followed by Phase 2 expansion cohorts to further evaluate the safety and efficacy of HLD-0915.

Phase 1 is conducted in patients with metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior systemic therapies. Phase 1 includes Part 1, an open-label monotherapy dose-escalation using a Bayesian optimal interval with backfill (BF-BOIN) design. Phase 1 also includes Part 2 (open-label), which evaluates the relative bioavailability of HLD-0915 formulations.

Phase 2 will evaluate the safety, PK, and anti-tumor activity of HLD-0915 administered at the RDEs. Phase 2, Part 1 will randomize patients and assess dose strengths in patients with mCRPC to support registrational dose selection. Additional Phase 2 open-label expansion cohorts will further evaluate preliminary safety and efficacy in patients with metastatic hormone-sensitive prostate cancer (mHSPC).

Study Type

Interventional

Enrollment (Estimated)

190

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Recruiting
        • Royal Marsden Hospital
  • United States
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Sarah Cannon Research Institute at HealthONE
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Yale - New Haven Hospital - Yale Cancer Center
    • Florida
      • Sarasota, Florida, United States, 34232
        • Recruiting
        • Florida Cancer Specialists
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Recruiting
        • START Midwest, LLC
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Recruiting
        • Carolina Urologic Research Center, LLC
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • SCRI Oncology Partners
    • Texas
      • Austin, Texas, United States, 78758
        • Recruiting
        • NEXT Austin
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas M.D. Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.)
Drug: HLD-0915 Hard Capsule
Experimental: Oral HLD-0915
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.)
Drug: HLD-0915 Hard Capsule
Experimental: Oral HLD-0915
Drug: HLD-0915 Tablet
Experimental: Oral HLD-0915
Drug: HLD-0915 Soft Capsule
Experimental: Oral HLD-0915
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.)
Drug: HLD-0915 Hard Capsule
Experimental: Oral HLD-0915
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.)
Drug: HLD-0915 Hard Capsule
Experimental: Oral HLD-0915
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.)
Drug: HLD-0915 Hard Capsule
Experimental: Oral HLD-0915
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.)
Drug: HLD-0915 Hard Capsule
Experimental: Oral HLD-0915
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.)
Drug: HLD-0915 Hard Capsule
Experimental: Oral HLD-0915

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of dose-limiting toxicities (DLTs)
Time Frame: 21 days
21 days
Frequency and severity of AEs and abnormal ECG, laboratory and clinical changes since baseline
Time Frame: 21 days
21 days
Phase 1 Part 2 (formulation exploration) relative bioavailability
Time Frame: 22 days
22 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PK Parameters
Time Frame: 21 days
21 days
Change in PSA over time
Time Frame: 21 days
Including PSA50 and PSA90 response
21 days
Objective Response Rate (ORR)
Time Frame: 63 days
Per RECIST in evaluable patients
63 days
Duration of Response (DOR)
Time Frame: 21 days
21 days
Radiographic Progression-Free Survival (rPFS)
Time Frame: 63 days
63 days
Time to Response (TTR)
Time Frame: 63 days
63 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Halda Therapeutics OpCo, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2025

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2030

Study Registration Dates

First Submitted

January 20, 2025

First Submitted That Met QC Criteria

January 27, 2025

First Posted (Actual)

January 30, 2025

Study Record Updates

Last Update Posted (Actual)

June 26, 2026

Last Update Submitted That Met QC Criteria

June 24, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HLD-0915-ONC-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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