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A First-in-Human Study of HH160 in Participants With Advanced or Metastatic Solid Tumors

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoints added 2 → 4 primary endpoints
See other at-risk trials from Huahui Health

Record History

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  1. Primary endpoint(s) modifiedv2 Show 9 more changesShow less
    • Recruitment opened
    • Enrollment increased: 56 → 299 participants
    • Trial sites expanded: 0 → 3 locations
    • Primary completion moved earlier from Aug 2028 to Aug 2027
    • Trial arms changed: 2 → 3
    • Start date changed from estimate of Jun 2026 to Jun 11, 2026
    • Secondary endpoints: 10 to 11
    • Study description expanded, about 21 words
    • Study title expanded, about 2 words
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Huahui Health
9 trials monitored
See 1 trial at risk
Breast Cancer
5,418 trials monitored
See 296 trials at risk
Lung Cancer
4,790 trials monitored
See 263 trials at risk
Colorectal Cancer
3,394 trials monitored
See 159 trials at risk
and 11 more diseases
This study is evaluating the safety, side effects, how the body processes HH160, and its early anticancer activity when given alone or with other cancer treatments in participants with advanced solid tumors. The study will also identify the recommended dose for future studies. The trial includes two phases and is expected to last about 4 years, with treatment and follow-up lasting approximately 6-12 months each.
Trial Details
NCT Number NCT07623369
Lead Sponsor Huahui Health
Collaborators: BeOne Medicines
Conditions
(from sponsor)		 Solid Tumor, Non-small Cell Lung Cancer, Hepatocellular Carcinoma, Colorectal Cancer, Head and Neck Squamous Cell Carcinoma, Renal Cell Carcinoma, Endometrial Cancer, Cervical Cancer +4 more
Related terms Carcinoma, Hepatocellular, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Carcinoma, Transitional Cell, Colorectal Neoplasms, Endometrial Neoplasms, Ovarian Neoplasms, Small Cell Lung Carcinoma, Squamous Cell Carcinoma of Head and Neck, Triple Negative Breast Neoplasms, Uterine Cervical Neoplasms
Enrollment 299 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov