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

Conditions

• Metastatic Prostate Cancer

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• JNJ-101556143 Formulation 1 — DRUG
  Experimental: Oral JNJ-101556143
• JNJ-101556143 Formulation 2 — DRUG
  Experimental: Oral JNJ-101556143
• JNJ-101556143 Formulation 3 — DRUG
  Experimental: Oral JNJ-101556143

Study Details

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.

Key Dates

First listed

Jan 30, 2025

Start date

Feb 6, 2025

Status verified

Aug 2026

Primary completion

Jul 11, 2028

Completion

Jul 11, 2028

Study Design

Enrollment

190 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: JNJ-101556143 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.)
• Experimental: JNJ-101556143 Phase 1 Part 2 - Formulation Exploration
  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.)
• Experimental: JNJ-101556143 Phase 2 Part 1 - Dose Optimization
  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.)
• Experimental: Phase 2 Part 2A - SOAR
  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.)
• Experimental: Phase 2 Part 2B - HSPC Expansion
  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.)
• Experimental: Phase 2 Part 2C - HSPC Expansion
  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.)
• Experimental: Phase 2 Part 2D - HSPC Expansion
  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.)

Primary Outcome Measure

Frequency of dose-limiting toxicities (DLTs) [ Time Frame: 21 days ]

Central Contacts

• Study Contact
  844-434-4210
  [email protected]

Locations (17)

Find similar trials in Colorado Springs, CO

Related Studies

• Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer
  PHASE2/PHASE3 · Recruiting · VA Office of Research and Development · Long Beach, California
• High Dose Testosterone for ATM, CDK12 or CHEK2 Altered Prostate Cancers
  PHASE2 · Recruiting · VA Office of Research and Development · Aurora, Colorado
• Study of ORIC-944 in Patients With Metastatic Prostate Cancer
  PHASE1 · Recruiting · ORIC Pharmaceuticals · Colorado Springs, Colorado
• A Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 In Participants With Advanced or Metastatic Prostate Cancer
  PHASE1 · Recruiting · Genentech, Inc. · Scottsdale, Arizona