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Recruiting Phase 1

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

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About this study

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.

Condition
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
Tested
HH160
Sponsor
Huahui Health

Who can join

Age
18 to 75 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 8

  • Minimum age: 18 years
  • Maximum age: 75 years
  • Study condition: 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
  • Adults aged 18 to 75 years with signed informed consent.
  • Histologically or cytologically confirmed advanced solid tumors meeting phase-specific disease requirements.
  • At least 1 measurable lesion per RECIST v1.1.
  • Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status of 0 or 1 with life expectancy ≥ 12 weeks.
  • Adequate organ function based on protocol-specified laboratory criteria.

Exclusion 6

  • Active leptomeningeal disease or uncontrolled/untreated brain metastases.
  • History of severe hypersensitivity reactions to monoclonal antibodies, bispecific antibodies, trispecific antibodies, or study drug components.
  • Other malignancy within 3 years prior to first dose, except specified curatively treated cancers.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage.
  • Significant bleeding risk, severe coagulopathy, gastrointestinal hemorrhage, or recent pulmonary hemorrhage/hemoptysis.
  • NOTE: Other eligibility criteria may apply.

Where

3 sites, 3 recruiting

Tasman Health Care

Southport, Queensland, Australia

Recruiting

Calvary Mater Newcastle

Waratah, New South Wales, Australia

Recruiting

Shandong Tumour Hospital Dongyuan Unit

Jinan, Shandong, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.