First-in-human test of HH160 in people with advanced solid tumors
Official title: 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
Run by Huahui Health · NCT07623369 · Data updated 2026-11-12
HH160 is being tested to see if it is safe and how it behaves in the body, to see if it has early signs of helping various advanced cancers in adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 299 (estimated) |
| Sponsor | Huahui Health Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Waratah, New South Wales and 2 other locations) |
| Status | Recruiting |
| Started | June 11, 2026 |
| Main results expected | August 2027 |
| Study ends | August 2028 |
| Registry record updated | August 21, 2026 |
| Trial ID | NCT07623369 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–75 with advanced solid tumors and at least one measurable lesion, ECOG 0–1, and adequate organ function.
✕Probably not a fit
Patients with certain brain metastases, active bleeding risks, or prior therapies likely to confound results may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This early-phase study assesses the safety, tolerability, how the drug is processed by the body, and preliminary anticancer activity of HH160 given alone or with other therapies in adults with advanced solid tumors. It aims to identify a recommended phase 1 dose (RP2D) for HH160 as a monotherapy and in combination regimens. The trial includes multiple tumor types, with NSCLC, HCC, CRC, and head and neck cancers among those eligible, and follows patients for treatment and follow-up over about 6–12 months per participant. The study is designed as a two-part Phase 1/interventional investigation to establish dosing and gather early efficacy signals.
Why it matters
Potential benefit: If successful, participants could experience disease control or tumor shrinkage and gain access to potentially new therapeutic options.
How similar studies have gone: Early-phase studies of similar multispecific antibodies have shown preliminary signals in some solid tumors, but this exact approach is in early development.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Calvary Mater Newcastle
Waratah, New South Wales, Australia Recruiting -
Tasman Health Care
Southport, Queensland, Australia Recruiting -
Shandong Tumour Hospital Dongyuan Unit
Jinan, Shandong, China Recruiting
Study contacts
- Study coordinator: Medical Officer
- Email: zhouxin@hhhbio.com
- Phone: +86-010-80766688
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.