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

ConditionMetastatic Prostate Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorJanssen Research & Development, LLC

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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

Treatment groups

190 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: JNJ-101556143 Phase 1 Part 1 - Dose EscalationExperimental treatment 1 intervention
Group B: JNJ-101556143 Phase 1 Part 2 - Formulation ExplorationExperimental treatment 3 interventions
Group C: JNJ-101556143 Phase 2 Part 1 - Dose OptimizationExperimental treatment 1 intervention
Group D: Phase 2 Part 2A - SOARExperimental treatment 1 intervention
Group E: Phase 2 Part 2B - HSPC ExpansionExperimental treatment 1 intervention
Group F: Phase 2 Part 2C - HSPC ExpansionExperimental treatment 1 intervention
Group G: Phase 2 Part 2D - HSPC ExpansionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Frequency of dose-limiting toxicities (DLTs)

Time frame
21 days
2

Frequency and severity of AEs and abnormal ECG, laboratory and clinical changes since baseline

Time frame
21 days
3

Phase 1 Part 2 (formulation exploration) relative bioavailability

Time frame
22 days

Secondary outcomes

1

PK Parameters

Time frame
21 days
2

Change in PSA over time

Including PSA50 and PSA90 response

Time frame
21 days
3

Objective Response Rate (ORR)

Per RECIST in evaluable patients

Time frame
63 days
4

Duration of Response (DOR)

Time frame
21 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Janssen Research & Development, LLC

Lead sponsor

Source ClinicalTrials.gov
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