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JNJ-101556143 Formulation 1

Phase 1

Metastatic Prostate Cancer | Small molecule | Oncology |Johnson & Johnson|Last Updated: Aug 31, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment190

FDA Designations

No designations recorded

Clinical trial landscape

JNJ-101556143 Formulation 1 · 1 trial · 1 indication

Phase 1 1
NCT06800313Study of HLD-0915 (JNJ-101556143) in Patients With Metastatic Prostate CancerMetastatic Prostate Cancer
RECRUITING190 Analytics
PHASE1RECRUITING
Study of HLD-0915 (JNJ-101556143) in Patients With Metastatic Prostate Cancer
Metastatic Prostate CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

PK Parameters
21 days
Change in PSA over time
21 days
Objective Response Rate (ORR)
63 days
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
JNJ-101556143 Phase 1 Part 1 - Dose EscalationEXPERIMENTALTreatment 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 ExplorationEXPERIMENTALTreatment 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 OptimizationEXPERIMENTALTreatment 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 - SOAREXPERIMENTALTreatment 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 ExpansionEXPERIMENTALTreatment 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 ExpansionEXPERIMENTALTreatment 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 ExpansionEXPERIMENTALTreatment 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.)

Interventions

NameTypeDescription
JNJ-101556143 Formulation 1DRUGExperimental: Oral JNJ-101556143
JNJ-101556143 Formulation 2DRUGExperimental: Oral JNJ-101556143
JNJ-101556143 Formulation 3DRUGExperimental: Oral JNJ-101556143
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites18

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 h...

Countries:United StatesUnited Kingdom
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Competitive Landscape -Prostate Cancer 254 trials (matched to "Metastatic Prostate Cancer")

Recent Changes (Last 90 Days)

LOWAug 31, 2026NCT06800313lastUpdatePostDate: changed
LOWAug 31, 2026NCT06800313lastUpdatePostDate: changed
MEDIUMAug 20, 2026NCT06800313primaryCompletionDate: changed
MEDIUMAug 20, 2026NCT06800313primaryCompletionDate: changed

Frequently asked questions about JNJ-101556143 Formulation 1

What is JNJ-101556143 Formulation 1 used for?

JNJ-101556143 Formulation 1 is an investigational small molecule being studied for the treatment of metastatic prostate cancer. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes JNJ-101556143 Formulation 1?

JNJ-101556143 Formulation 1 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker symbol JNJ.

What phase is JNJ-101556143 Formulation 1 in?

JNJ-101556143 Formulation 1 is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. A Phase 1 trial is currently recruiting participants.

What clinical trials is JNJ-101556143 Formulation 1 in?

JNJ-101556143 Formulation 1 is being studied in a Phase 1 trial with the identifier NCT06800313. This trial, titled 'Study of HLD-0915 (JNJ-101556143) in Patients With Metastatic Prostate Cancer,' is recruiting male patients aged 18 years and older in the United States and United Kingdom.

Is JNJ-101556143 Formulation 1 the same as HLD-0915?

Yes, JNJ-101556143 Formulation 1 is also known as HLD-0915. The clinical trial NCT06800313 refers to the drug as HLD-0915 (JNJ-101556143), indicating that these names are used interchangeably for the same investigational agent.