Recruiting nowPhase 1
What this trial is trying to do
The researchers are testing whether HH160, given alone or alongside other cancer treatments, can be administered safely to people with advanced solid tumours. They will study how the body processes the drug, look for early signs of anticancer activity, and identify doses for later trials.
Because this is a first-in-human, non-randomised study, there is no treatment comparison; the immediate aim is to define side effects and a dose that can be tested more fully later. The main measure is treatment-related and serious adverse events, rather than longer survival or delaying cancer growth.
Worth knowing: This early-phase trial is designed primarily to assess safety and dosing, so it cannot establish whether HH160 benefits patients.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT07623369 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 1 |
| Design | not randomised, open label |
| Taking part | 299 people (planned) |
| Who can join | aged 18 Years to 75 Years |
| Run by | Huahui Health |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug HH160
What it is measuring
Phase 1a: Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 1. Tests safety and dose in a small group. Some people do benefit, but that is not what the trial is designed to find out.
How the researchers describe it
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.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
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.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 3 sites. Listed in: Australia, China.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT07623369, registered by Huahui Health on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.