NCT07623369 A First-in-Human Study of HH160 in Participants With Advanced or Metastatic Solid Tumors
| NCT ID | NCT07623369 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Huahui Health |
| Condition | Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 299 participants |
| Start Date | 2026-06-11 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 299 participants in total. It began in 2026-06-11 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Study Director
STUDY DIRECTOR
BeOne Medicines
Frequently Asked Questions
Who can join the NCT07623369 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07623369 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07623369 currently recruiting?
Yes, NCT07623369 is actively recruiting participants. Contact the research team at zhouxin@hhhbio.com for enrollment information.
Where is the NCT07623369 trial being conducted?
This trial is being conducted at Waratah, Australia, Southport, Australia, Jinan, China.
Who is sponsoring the NCT07623369 clinical trial?
NCT07623369 is sponsored by Huahui Health. The principal investigator is Study Director at BeOne Medicines. The trial plans to enroll 299 participants.