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A Study of JNJ-101684362 (HLD-0117) in Patients With Metastatic Breast Cancer

Study acronym: HLD-0117
StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Lead sponsor: Janssen Research & Development, LLC to Janssen Research & Development, LLC Interventions modified · Eligibility criteria expanded, about 256 words · Secondary endpoints: 4 to 5 · 2 more Show 5 more changesShow less
    • Interventions modified
    • Eligibility criteria expanded, about 256 words
    • Secondary endpoints: 4 to 5
    • Study description shortened, about 112 words
    • Study title expanded, about 1 word
  2. Enrollment increased: 33 → 170 participants Completion pushed from Apr 30, 2028 to Oct 10, 2029 · Study sites: 4 to 6v3 Show 2 more changesShow less
    • Completion pushed from Apr 30, 2028 to Oct 10, 2029
    • Study sites: 4 to 6
  3. Changed Sponsor changed: Halda Therapeutics OpCo, Inc. to Janssen Research & Development, LLC
  4. Study sites: 3 to 4 Start date changed from estimate of Mar 31, 2026 to Apr 9, 2026v2 Show 1 more changeShow less
    • Start date changed from estimate of Mar 31, 2026 to Apr 9, 2026
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Johnson & Johnson
289 trials monitored
See 17 trials at risk
Breast Cancer
5,213 trials monitored
See 271 trials at risk
The purpose of this study is to find out the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDEs) of JNJ-101684362 (HLD-0117), to evaluate the safety of JNJ-101684362 (HLD-0117) , and how well the participants can tolerate it in Part 1 (dose escalation) of the study.
Trial Details
NCT Number NCT07524855
Lead Sponsor Janssen Research & Development, LLC
Conditions Metastatic Breast Cancer
Enrollment 170 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov