A First-in-Human Study of HH160 in Participants With Advanced or Metastatic Solid Tumors
Recruiting · NCT07623369 · Interventional (participants receive a specific treatment) · Lead sponsor: Huahui Health
View the official record on ClinicalTrials.gov →Interventions studied
HH160
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
- Key
Exclusion criteria
- 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 it is running
9 locations listed.
- Calvary Mater Newcastle - Waratah, New South Wales, Australia
- Calvary Mater Newcastle - Waratah, New South Wales, Australia
- Calvary Mater Newcastle - Waratah, New South Wales, Australia
- Tasman Health Care - Southport, Queensland, Australia
- Tasman Health Care - Southport, Queensland, Australia
- Tasman Health Care - Southport, Queensland, Australia
- Shandong Tumour Hospital Dongyuan Unit - Jinan, Shandong, China
- Shandong Tumour Hospital Dongyuan Unit - Jinan, Shandong, China
- Shandong Tumour Hospital Dongyuan Unit - Jinan, Shandong, China