Study of HLD-0915 (JNJ-101556143) in Patients With Metastatic Prostate Cancer

Janssen (J&J Innovative Medicine)

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Metastatic Prostate Cancer

Treatments: Drug: JNJ-101556143 Formulation 1; Drug: JNJ-101556143 Formulation 3; Drug: JNJ-101556143 Formulation 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT06800313

HLD-0915-ONC-101

Details and patient eligibility

About

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.

Enrollment: 190 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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190 participants in 7 patient groups

JNJ-101556143 Phase 1 Part 1 - Dose Escalation

Experimental group

Description:

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.)

Treatment:

Drug: JNJ-101556143 Formulation 1

JNJ-101556143 Phase 1 Part 2 - Formulation Exploration

Experimental group

Description:

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.)

Treatment:

Drug: JNJ-101556143 Formulation 2

Drug: JNJ-101556143 Formulation 3

Drug: JNJ-101556143 Formulation 1

JNJ-101556143 Phase 2 Part 1 - Dose Optimization

Experimental group

Description:

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.)

Treatment:

Drug: JNJ-101556143 Formulation 1

Phase 2 Part 2A - SOAR

Experimental group

Description:

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.)

Treatment:

Drug: JNJ-101556143 Formulation 1

Phase 2 Part 2B - HSPC Expansion

Experimental group

Description:

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.)

Treatment:

Drug: JNJ-101556143 Formulation 1

Phase 2 Part 2C - HSPC Expansion

Experimental group

Description:

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.)

Treatment:

Drug: JNJ-101556143 Formulation 1

Phase 2 Part 2D - HSPC Expansion

Experimental group

Description:

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.)

Treatment:

Drug: JNJ-101556143 Formulation 1