NCT07623369RecruitingPhase 1
A First-in-Human Study of HH160 in Participants With Advanced or Metastatic Solid Tumors
An Open-Label, Multicenter, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Preliminary Antitumor Activity of HH160 Alone or in Combination With Other Antitumor Agents in Patients With Advanced or Metastatic Solid Tumors
Source: ClinicalTrials.gov · Last updated 21 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 299 (estimated)
- First submitted
- 29 May 2026
- Start date
- 11 Jun 2026
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- Huahui Health
- Diseases
- Triple-negative breast cancer, Head and neck cancer, Kidney cancer, Bladder cancer, Endometrial cancer, Cervical cancer, Lung cancer, Colorectal cancer, Liver and biliary tract cancer, Ovarian cancer
- NCT number
- NCT07623369
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 299
- From 11 Jun 2026 to the primary completion date, 31 Aug 2027
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Other malignancy within 3 years prior to first dose, except specified curatively treated cancers.
Other illness
- Active leptomeningeal disease or uncontrolled/untreated brain metastases.
- History of severe hypersensitivity reactions to monoclonal antibodies, bispecific antibodies, trispecific antibodies, or study drug components.
- Significant bleeding risk, severe coagulopathy, gastrointestinal hemorrhage, or recent pulmonary hemorrhage/hemoptysis.
- NOTE: Other eligibility criteria may apply.
Other
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tasman Health Care Coordinator of this site? Confirm its status | Southport | Australia | Recruiting |
| Calvary Mater Newcastle Coordinator of this site? Confirm its status | Waratah | Australia | Recruiting |
| Shandong Tumour Hospital Dongyuan Unit Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.