Solid TumorPhase 1NCT07623369
A First-in-Human Study of HH160 in Participants With Advanced or Metastatic Solid Tumors
A Phase 1 study testing HH160 in people with Solid Tumor and Non-small Cell Lung Cancer, run by Huahui Health at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor, Non-small Cell Lung Cancer, Hepatocellular Carcinoma
- What is being tested?
- HH160
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 299 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 11 Jun 2026to Aug 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Australia2 sites, 2 recruiting
- Recruiting
Tasman Health Care
Southport, Queensland, 4215
- Recruiting
Calvary Mater Newcastle
Waratah, New South Wales, 2298
China1 site, 1 recruiting
- Recruiting
Shandong Tumour Hospital Dongyuan Unit
Jinan, Shandong
About this study
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
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.
Read the detailed description
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD), and preliminary antitumor activity of HH160 alone or in combination with antitumor agents in participants with advanced or solid tumors, including non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC), colorectal cancer (CRC), gastroesophageal adenocarcinoma (GEA), head and neck squamous cell carcinoma, renal cell carcinoma (RCC), endometrial carcinoma, cervical cancer, ovarian cancer, small cell lung cancer, triple-negative breast cancer, urothelial carcinoma, and additional tumor types based on emerging clinical data.
The study will also identify the recommended phase 1 dose (RP2D) of HH160 monotherapy and/or in combination with other chemotherapy regimens.
- Conditions
- Solid Tumor, Non-small Cell Lung Cancer, Hepatocellular Carcinoma, Colorectal Cancer, Head and Neck Squamous Cell Carcinoma, Renal Cell Carcinoma
- Being tested
- HH160
- Keywords
- HH160, PD-1×CTLA-4×VEGF-A Antibody, Non-small Cell Lung Cancer, NSCLC, Hepatocellular Carcinoma, HCC, Colorectal Cancer, CRC, GEA, Head and Neck Squamous Cell Carcinoma, Renal Cell Carcinoma, RCC, Endometrial Cancer, Cervical Cancer, Small-cell Lung Cancer, Triple Negative Breast Cancer, TNBC, Urothelial Carcinoma, Gastroesophageal Adenocarcinoma, Ovarian Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Hepatocellular, Colorectal Neoplasms, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Renal Cell, Endometrial Neoplasms, Uterine Cervical Neoplasms, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HH160Drug
Administered by intravenous infusion on Day 1 of each 21-day (Q3W) cycle or 14-day (Q2W) cycle.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a Part 1 : Dose Escalation | Experimental | Participants with advanced solid tumors will receive escalating doses of HH160 Receives: Drug: HH160 |
| Phase 1a Part 2: Safety Expansion | Experimental | Participants with selected advanced or metastatic solid tumors will receive HH160 at dose levels determined to be tolerable during dose escalation to further evaluate safety and tolerability. Receives: Drug: HH160 |
| Phase 1b: Dose Expansion | Experimental | Additional participants with selected advanced or metastatic solid tumors will receive HH160 alone or in combination with chemotherapy at selected expansion dose levels and schedules identified during phase 1a. Receives: Drug: HH160 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1a: Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Assessed by treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events meeting protocol-defined dose-limiting toxicity (DLT) criteria.
Measured: From first dose of study drug to 30 days after last dose or initiation of a new anticancer therapy, whichever occurs first; up to approximately 12 months
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of HH160
The MTD or MAD is defined as the highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 28%, or the highest dose administered, respectively.
Measured: From first dose through the end of Cycle 1 (approximately 1 month)
Phase 1b: Recommended Phase 2 Dose (RP2D) of HH160
RP2D is defined as the dose level selected based on the overall assessment of safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy
Measured: From first dose through completion of Phase 1b dose optimization (up to 2 years)
Phase 1b: Overall Response Rate (ORR)
Defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) assessed by the investigator.
Measured: Up to 2 years
Secondary outcomes (11)
Phase 1a: Objective Response Rate (ORR)
Defined as the percentage of participants who achieved complete response (CR) or partial response (PR) as determined by investigator assessment using RECIST v1.1.
Measured: Up to 2 years
Disease Control Rate (DCR)
Defined as the percentage of participants who achieve a best overall response of complete response (CR), partial response (PR), or stable disease (SD) as determined by investigator assessment using RECIST v1.1.
Measured: Up to 2 years
Duration of Response (DOR)
Defined as the time from the date that a response (CR or PR) was first observed to the date of first documented disease progression or death, whichever occurred first as determined by investigator assessment using RECIST v1.1.
Measured: Up to 2 years
Progression-free Survival (PFS)
PFS is defined as time from start of treatment to the first documentation of disease progression or death, whichever occurs first as determined by investigator assessment using RECIST v1.1.
Measured: Up to 2 years
Phase 1a: Time to Response (TTR)
TTR is defined as the time from start of treatment to the first date that response criteria (CR or PR) were met, as determined by investigator assessment using RECIST v1.1.
Measured: Up to 2 years
Maximum Observed Plasma Concentration (Cmax) of HH160
Measured: Up to 4 months
Elimination Half Time (T1/2) of HH160
Measured: Up to 4 months
Time to Maximum Observed Plasma Concentration (Tmax)
Measured: Up to 4 months
Observed Clearance of HH160
Measured: Up to 4 months
Area Under the Curve From Time Zero to Last Measurable Concentration (AUClast)
Measured: Up to 4 months
Phase 1b: Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Assessed by treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and AEs meeting protocol-defined adverse event of clinical interests (AECIs)..
Measured: From first dose of study drug to 30 days after last dose or initiation of a new anticancer therapy, whichever occurs first; up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start11 Jun 2026
- Primary completionAug 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 299 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huahui Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BeOne Medicines
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeOne Medicines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07623369
- Sponsor's protocol ID
- HH160-101
- Other IDs
- Himalaya
- Status last verified
- Aug 2026
- First submitted
- 29 May 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07623369
- Acronym / sponsor ID
- HH160-101
- Conditions
- Solid Tumor, Non-small Cell Lung Cancer, Hepatocellular Carcinoma, Colorectal Cancer, Head and Neck Squamous Cell Carcinoma, Renal Cell Carcinoma
- Keywords
- HH160, PD-1×CTLA-4×VEGF-A Antibody, Non-small Cell Lung Cancer, NSCLC, Hepatocellular Carcinoma, HCC, Colorectal Cancer, CRC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 299 participants (estimated)
- Lead sponsor
- Huahui HealthIndustry (pharma, biotech, devices)
- Collaborators
- BeOne Medicines
- Study start
- 11 Jun 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD), and preliminary antitumor activity of HH160 alone or in combination with antitumor agents in participants with advanced or solid tumors, including non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC), colorectal cancer (CRC), gastroesophageal adenocarcinoma (GEA), head and neck squamous cell carcinoma, renal cell carcinoma (RCC), endometrial carcinoma, cervical cancer, ovarian cancer, small cell lung cancer, triple-negative breast cancer, urothelial carcinoma, and additional tumor types based on emerging clinical data.
The study will also identify the recommended phase 1 dose (RP2D) of HH160 monotherapy and/or in combination with other chemotherapy regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1a Part 1 : Dose Escalation | Experimental | Drug: HH160Participants with advanced solid tumors will receive escalating doses of HH160 |
| Phase 1a Part 2: Safety Expansion | Experimental | Drug: HH160Participants with selected advanced or metastatic solid tumors will receive HH160 at dose levels determined to be tolerable during dose escalation to further evaluate safety and tolerability. |
| Phase 1b: Dose Expansion | Experimental | Drug: HH160Additional participants with selected advanced or metastatic solid tumors will receive HH160 alone or in combination with chemotherapy at selected expansion dose levels and schedules identified during phase 1a. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HH160Administered by intravenous infusion on Day 1 of each 21-day (Q3W) cycle or 14-day (Q2W) cycle. | Drug | Phase 1a Part 1 : Dose Escalation, Phase 1a Part 2: Safety Expansion, Phase 1b: Dose Expansion |
Primary outcome
Phase 1a: Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: From first dose of study drug to 30 days after last dose or initiation of a new anticancer therapy, whichever occurs first; up to approximately 12 months
Assessed by treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events meeting protocol-defined dose-limiting toxicity (DLT) criteria.
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of HH160
Time frame: From first dose through the end of Cycle 1 (approximately 1 month)
The MTD or MAD is defined as the highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 28%, or the highest dose administered, respectively.
Phase 1b: Recommended Phase 2 Dose (RP2D) of HH160
Time frame: From first dose through completion of Phase 1b dose optimization (up to 2 years)
RP2D is defined as the dose level selected based on the overall assessment of safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy
Phase 1b: Overall Response Rate (ORR)
Time frame: Up to 2 years
Defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) assessed by the investigator.
11 secondary outcomes
Phase 1a: Objective Response Rate (ORR)
Time frame: Up to 2 years
Disease Control Rate (DCR)
Time frame: Up to 2 years
Duration of Response (DOR)
Time frame: Up to 2 years
Progression-free Survival (PFS)
Time frame: Up to 2 years
Phase 1a: Time to Response (TTR)
Time frame: Up to 2 years
Maximum Observed Plasma Concentration (Cmax) of HH160
Time frame: Up to 4 months
Elimination Half Time (T1/2) of HH160
Time frame: Up to 4 months
Time to Maximum Observed Plasma Concentration (Tmax)
Time frame: Up to 4 months
Observed Clearance of HH160
Time frame: Up to 4 months
Area Under the Curve From Time Zero to Last Measurable Concentration (AUClast)
Time frame: Up to 4 months
Phase 1b: Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: From first dose of study drug to 30 days after last dose or initiation of a new anticancer therapy, whichever occurs first; up to approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Director study director
BeOne Medicines
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HH160 in people with Solid Tumor and Non-small Cell Lung Cancer, run by Huahui Health at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medical Officer (+86-010-80766688, zhouxin@hhhbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1a: Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: From first dose of study drug to 30 days after last dose or initiation of a new anticancer therapy, whichever occurs first; up to approximately 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.