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RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: Huahui Health • ClinicalTrials.gov ID: NCT07623369

Registry updated: 2026-08-21
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Description

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.

Interventions

  • HH160 (Drug)
    Administered by intravenous infusion on Day 1 of each 21-day (Q3W) cycle or 14-day (Q2W) cycle.

Eligibility criteria

Key Inclusion Criteria 1. Adults aged 18 to 75 years with signed informed consent. 2. Histologically or cytologically confirmed advanced solid tumors meeting phase-specific disease requirements. 3. At least 1 measurable lesion per RECIST v1.1. 4. Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status of 0 or 1 with life expectancy ≥ 12 weeks. 5. Adequate organ function based on protocol-specified laboratory criteria. Key Exclusion Criteria 1. Active leptomeningeal disease or uncontrolled/untreated brain metastases. 2. History of severe hypersensitivity reactions to monoclonal antibodies, bispecific antibodies, trispecific antibodies, or study drug components. 3. Other malignancy within 3 years prior to first dose, except specified curatively treated cancers. 4. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage. 5. Significant bleeding risk, severe coagulopathy, gastrointestinal hemorrhage, or recent pulmonary hemorrhage/hemoptysis. NOTE: Other eligibility criteria may apply.

Conditions

Solid Tumor Non-small Cell Lung Cancer Hepatocellular Carcinoma Colorectal Cancer Head and Neck Squamous Cell Carcinoma Renal Cell Carcinoma Endometrial Cancer Cervical Cancer Small-cell Lung Cancer Triple Negative Breast Cancer Urothelial Carcinoma Gastroesophageal Adenocarcinoma

Locations

  • Calvary Mater Newcastle — Waratah, New South Wales, Australia
  • Tasman Health Care — Southport, Queensland, Australia
  • Shandong Tumour Hospital Dongyuan Unit — Jinan, Shandong, China
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record