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Study of HLD-0915 (JNJ-101556143) in Patients With Metastatic Prostate Cancer
Metastatic Prostate Cancer
Clinicaltrials.gov:
Other:
#HLD-0915-ONC-101
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Trials at a glance
Status
Enrolling
Condition
Metastatic Prostate Cancer
Trial type
Interventional
Trial phase
Phase 1
Investigational
product
product
JNJ-101556143 Formulation 1
JNJ-101556143 Formulation 2
JNJ-101556143 Formulation 3
Age
18+ years old
Biological sex
Male
Placebo?
No
Trial start date
February 6, 2025
Trial end date
August 17, 2028
CT.gov ID
#NCT06800313
Share the trial ID with your doctor to see if trial participation is right for you. Participation depends on an independent medical assessment.
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.
Primary outcome measures
- Frequency of dose-limiting toxicities (DLTs)
- Frequency and severity of AEs and abnormal ECG, laboratory and clinical changes since baseline
- Phase 1 Part 2 (formulation exploration) relative bioavailability
Secondary outcome measures
- PK Parameters
- Change in PSA over time
- Objective Response Rate (ORR)
- Duration of Response (DOR)
- Radiographic Progression-Free Survival (rPFS)
- Time to Response (TTR)
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