Metastatic Prostate CancerPhase 1/2NCT06800313
Study of HLD-0915 (JNJ-101556143) in Patients With Metastatic Prostate Cancer
A Phase 1/2 study testing JNJ-101556143 Formulation 1, JNJ-101556143 Formulation 2 and JNJ-101556143 Formulation 3 in people with Metastatic Prostate Cancer, run by Janssen Research & Development, LLC at 18 sites in 2 countries.
Trial summary
Assessment of the safety and efficacy of HLD-0915 (JNJ-101556143) in patients with metastatic prostate cancer who have progressed on prior systemic therapies, with further evaluation in additional prostate cancer populations. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Prostate Cancer
- What is being tested?
- JNJ-101556143 Formulation 1, JNJ-101556143 Formulation 2 and JNJ-101556143 Formulation 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 18 sitesin 2 countries
- Study dates
- 6 Feb 2025to 17 Aug 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
18 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
18 sites in 2 countries
United States17 sites, 17 recruiting
- Recruiting
NEXT Oncology
Austin, Texas, 78758
- Recruiting
Dana Farber Mass General Brigham Cancer Care Inc
Boston, Massachusetts, 02114
- Recruiting
Rocky Mountain Cancer Center
Colorado Springs, Colorado, 80909
- Recruiting
Sarah Cannon Research Institute 1
Denver, Colorado, 80218
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
- Recruiting
South Texas Accelerated Research Therapeutics, LLC (START)
Grand Rapids, Michigan, 49546
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
Memorial Sloan Kettering Cancer Center
Long Island City, New York, 11101
- Recruiting
XCancer Research Network LCMC Health EJGH
Metairie, Louisiana, 70006
- Recruiting
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
- Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
- Recruiting
Urology Associates
Nashville, Tennessee, 37209
- Recruiting
Yale University
New Haven, Connecticut, 06511
- Recruiting
Virginia Clinical Research
Norfolk, Virginia, 23502
- Recruiting
Urology Cancer Center, PC
Omaha, Nebraska, 68130
- Recruiting
Florida Cancer Specialists
Sarasota, Florida, 34232
- Recruiting
Associated Medical Professionals
Syracuse, New York, 13210
United Kingdom1 site, 1 recruiting
- Recruiting
The Royal Marsden NHS Trust
Sutton, SM2 5PT
About this study
Official title: Phase 1/2 Study of HLD-0915 (JNJ-101556143) in Patients With Metastatic Prostate Cancer
Assessment of the safety and efficacy of HLD-0915 (JNJ-101556143) 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
- Being tested
- JNJ-101556143 Formulation 1, JNJ-101556143 Formulation 2, JNJ-101556143 Formulation 3
- 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
- Medical subject headings
- Prostatic Neoplasms, Genital Neoplasms, Male, Urogenital Neoplasms, Genital Diseases, Male, Male Urogenital Diseases, Neoplasms, Glandular and Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-101556143 Formulation 1Drug
Experimental: Oral JNJ-101556143
JNJ-101556143 Formulation 2Drug
Experimental: Oral JNJ-101556143
JNJ-101556143 Formulation 3Drug
Experimental: Oral JNJ-101556143
| Study group | Role | What they receive |
|---|---|---|
| JNJ-101556143 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.) Receives: Drug: JNJ-101556143 Formulation 1 |
| JNJ-101556143 Phase 1 Part 2 - Formulation Exploration | 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.) Receives: Drug: JNJ-101556143 Formulation 1; Drug: JNJ-101556143 Formulation 2; Drug: JNJ-101556143 Formulation 3 |
| JNJ-101556143 Phase 2 Part 1 - Dose Optimization | 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.) Receives: Drug: JNJ-101556143 Formulation 1 |
| Phase 2 Part 2A - SOAR | 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.) Receives: Drug: JNJ-101556143 Formulation 1 |
| Phase 2 Part 2B - HSPC Expansion | 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.) Receives: Drug: JNJ-101556143 Formulation 1 |
| Phase 2 Part 2C - HSPC Expansion | 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.) Receives: Drug: JNJ-101556143 Formulation 1 |
| Phase 2 Part 2D - HSPC Expansion | 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.) Receives: Drug: JNJ-101556143 Formulation 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of dose-limiting toxicities (DLTs)
Measured: 21 days
Frequency and severity of AEs and abnormal ECG, laboratory and clinical changes since baseline
Measured: 21 days
Phase 1 Part 2 (formulation exploration) relative bioavailability
Measured: 22 days
Secondary outcomes (6)
PK Parameters
Measured: 21 days
Change in PSA over time
Including PSA50 and PSA90 response
Measured: 21 days
Objective Response Rate (ORR)
Per RECIST in evaluable patients
Measured: 63 days
Duration of Response (DOR)
Measured: 21 days
Radiographic Progression-Free Survival (rPFS)
Measured: 63 days
Time to Response (TTR)
Measured: 63 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start6 Feb 2025
- Primary completion17 Aug 2028 (estimated)
- Study completion17 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Prostate CancerStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800313
- Sponsor's protocol ID
- HLD-0915-ONC-101
- Other IDs
- HLD-0915-ONC-101
- Status last verified
- Nov 2026
- First submitted
- 20 Jan 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2 Study of HLD-0915 (JNJ-101556143) in Patients With Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT06800313
- Acronym / sponsor ID
- HLD-0915-ONC-101
- 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
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- 17 Aug 2028 (estimated)
- Study completion
- 17 Aug 2028 (estimated)
- First posted
- 30 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessment of the safety and efficacy of HLD-0915 (JNJ-101556143) in patients with metastatic prostate cancer who have progressed on prior systemic therapies, with further evaluation in additional prostate cancer populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| JNJ-101556143 Phase 1 Part 1 - Dose Escalation | Experimental | Drug: JNJ-101556143 Formulation 1Treatment 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.) |
| JNJ-101556143 Phase 1 Part 2 - Formulation Exploration | Experimental | Drug: JNJ-101556143 Formulation 1, Drug: JNJ-101556143 Formulation 2, Drug: JNJ-101556143 Formulation 3Treatment 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.) |
| JNJ-101556143 Phase 2 Part 1 - Dose Optimization | Experimental | Drug: JNJ-101556143 Formulation 1Treatment 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.) |
| Phase 2 Part 2A - SOAR | Experimental | Drug: JNJ-101556143 Formulation 1Treatment 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.) |
| Phase 2 Part 2B - HSPC Expansion | Experimental | Drug: JNJ-101556143 Formulation 1Treatment 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.) |
| Phase 2 Part 2C - HSPC Expansion | Experimental | Drug: JNJ-101556143 Formulation 1Treatment 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.) |
| Phase 2 Part 2D - HSPC Expansion | Experimental | Drug: JNJ-101556143 Formulation 1Treatment 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.) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-101556143 Formulation 1Experimental: Oral JNJ-101556143 | Drug | JNJ-101556143 Phase 1 Part 1 - Dose Escalation, JNJ-101556143 Phase 1 Part 2 - Formulation Exploration, JNJ-101556143 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 |
| JNJ-101556143 Formulation 2Experimental: Oral JNJ-101556143 | Drug | JNJ-101556143 Phase 1 Part 2 - Formulation Exploration |
| JNJ-101556143 Formulation 3Experimental: Oral JNJ-101556143 | Drug | JNJ-101556143 Phase 1 Part 2 - Formulation Exploration |
Primary outcome
Frequency of dose-limiting toxicities (DLTs)
Time frame: 21 days
Frequency and severity of AEs and abnormal ECG, laboratory and clinical changes since baseline
Time frame: 21 days
Phase 1 Part 2 (formulation exploration) relative bioavailability
Time frame: 22 days
6 secondary outcomes
PK Parameters
Time frame: 21 days
Change in PSA over time
Time frame: 21 days
Objective Response Rate (ORR)
Time frame: 63 days
Duration of Response (DOR)
Time frame: 21 days
Radiographic Progression-Free Survival (rPFS)
Time frame: 63 days
Time to Response (TTR)
Time frame: 63 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing JNJ-101556143 Formulation 1, JNJ-101556143 Formulation 2 and JNJ-101556143 Formulation 3 in people with Metastatic Prostate Cancer, run by Janssen Research & Development, LLC at 18 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of dose-limiting toxicities (DLTs) (time frame: 21 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.