Solid TumorPhase 1NCT07554196
A Phase 1 Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HH-101 in Patients With Advanced Solid Tumors
A Phase 1 study testing HH-101 (0.3 mg/kg), HH-101 (1 mg/kg ) and HH-101 (3 mg/kg ) in people with Solid Tumor, run by Huahui Health at 1 site in China.
Trial summary
The goal of this study is to evaluate the safety of HH-101 antibody, administered as monotherapy to participants with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- HH-101 (0.3 mg/kg), HH-101 (1 mg/kg ) and HH-101 (3 mg/kg )
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 19 Jan 2022to 21 Mar 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Voluntary signing of the written informed consent form;
- Histologic or cytologic confirmation of advanced solid tumor;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- Have an estimated life expectancy ≥3 Months, in the judgement of the investigator;
- Must have at least 1 measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Who cannot join
- History of other malignancies within 5 years prior to the first dose of study drug, except for malignancies that have been cured after treatment, such as thyroid cancer, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of the breast.
- Receipt of the last systemic anti-tumor therapy within 2 weeks prior to the first dose of study drug, including chemotherapy, radiotherapy, targeted therapy, or traditional Chinese herbal medicine or patent Chinese medicines with anti-tumor activity. Patients who received tumor immune checkpoint inhibitor therapy within 4 weeks prior to the first dose of study drug.
- Adverse reactions from previous treatments that have not recovered to CTCAE v5.0 Grade 1 or lower (except for alopecia and neuropathy, which, in the Investigator's judgment, are long-standing and not expected to recover).
- Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
- If female, is pregnant, breastfeeding, or planning to become pregnant.
- Known hypersensitivity to HH-101 Injection or any of its components. History of severe hypersensitivity reactions to other therapeutic antibody drugs. Known allergy to multiple substances or history of severe allergic diseases.
- Known interstitial lung disease or non-infectious pneumonitis requiring steroid therapy.
- Other severe, acute, or chronic medical conditions, psychiatric disorders, or laboratory abnormalities that, in the Investigator's judgment, may increase the risk associated with study participation or may interfere with the interpretation of study results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Phase 1 Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HH-101 as Monotherapy in Patients With Advanced Solid Tumors
The goal of this study is to evaluate the safety of HH-101 antibody, administered as monotherapy to participants with advanced solid tumors.
- Conditions
- Solid Tumor
- Being tested
- HH-101 (0.3 mg/kg), HH-101 (1 mg/kg ), HH-101 (3 mg/kg ), HH-101 (10 mg/kg)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HH-101 (0.3 mg/kg)Drug
Participants received 0.3 mg/kg HH-101 as an intravenous (IV) infusion on day (D)1 and D21 of each 21-day cycle every 3 weeks (Q3W).
HH-101 (1 mg/kg )Drug
Participants received 1 mg/kg HH-101 as an intravenous (IV) infusion on day (D)1 and D21 of each 21-day cycle every 3 weeks (Q3W).
HH-101 (3 mg/kg )Drug
Participants received 3 mg/kg HH-101 as an intravenous (IV) infusion on day (D)1 and D21 of each 21-day cycle every 3 weeks (Q3W).
HH-101 (10 mg/kg)Drug
Participants received 10 mg/kg HH-101 as an intravenous (IV) infusion on day (D)1 and D21 of each 21-day cycle every 3 weeks (Q3W).
| Study group | Role | What they receive |
|---|---|---|
| HH-101 Dose escalation (cohort 1) | Experimental | Not described Receives: Drug: HH-101 (0.3 mg/kg) |
| HH-101 Dose escalation (cohort 2) | Experimental | Not described Receives: Drug: HH-101 (1 mg/kg ) |
| HH-101 Dose escalation (cohort 3) | Experimental | Not described Receives: Drug: HH-101 (3 mg/kg ) |
| HH-101 Dose escalation (cohort 4) | Experimental | Not described Receives: Drug: HH-101 (10 mg/kg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs), serious adverse events (SAEs), and dose limiting toxicities (DLTs) per Common Terminology Criteria for Adverse Events v6.0 (CTCAE v5.0)
It will be assessed by the frequency, severity and nature of AEs, serious adverse event (SAE), changes in vital signs, physical examination, 12-lead ECG, laboratory tests (haematology, blood chemistry, urinalysis, coagulation Function, Thyroid Function Test and etc.), The severity of AEs will be graded by the NCI CTCAE version 5.0 and the AE terms will be coded by the current version of the Medical Dictionary for Regulatory Activities (MedDRA).
Measured: Baseline through safety follow up completion (Up To 24 Months)
Secondary outcomes (9)
Area under the concentration-time curve (AUC)
Measured: up to 24 months
Maximum observed plasma concentration (Cmax).
Measured: up to 24 months
Time to reach Cmax (Tmax).
Measured: up to 24 months
Terminal elimination half-life (t1/2).
Measured: up to 24 months
Objective response rate (ORR)
Investigate preliminary antitumor activity of HH-101 as assessed by radiological response per RECIST v1.1. ORR is defined as the proportion of subjects who achieve a Complete Response (CR) or Partial Response (PR) following treatment.
Measured: Baseline through Measured Progressive Disease (Up To 24 Months)
Disease control rate (DCR)
Investigate preliminary antitumor activity of HH-101 as assessed by radiological response per RECIST v1.1. DCR is defined as the proportion of subjects who achieve Complete Response (CR), Partial Response (PR), or Stable Disease (SD) following treatment.
Measured: Baseline through Measured Progressive Disease (Up To 24 Months)
Duration of response (DOR)
Investigate preliminary antitumor activity of HH-101 as assessed by radiological response per RECIST v1.1. DOR is defined as the time from the first documentation of objective response until the first documentation of tumor progression or death from any cause.
Measured: Baseline through Measured Progressive Disease or death (Up To 24 Months)
progression-free survival (PFS)
Investigate preliminary antitumor activity of HH-101 as assessed by radiological response per RECIST v1.1. PFS is defined as the time from the start of treatment until the first documentation of tumor progression or death from any cause.
Measured: Baseline through Measured Progressive Disease or death (Up To 24 Months)
overall survival (OS)
Investigate preliminary antitumor activity of HH-101 as assessed by radiological response per RECIST v1.1. OS is defined as the time from the start of treatment until death from any cause.
Measured: Baseline through the date of death from any cause (Up to 24 Months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start19 Jan 2022
- Primary completion9 Aug 2023
- Study completion21 Mar 2024
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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huahui Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07554196
- Sponsor's protocol ID
- HH101-101
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Phase 1 Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HH-101 as Monotherapy in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07554196
- Acronym / sponsor ID
- HH101-101
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Huahui HealthIndustry (pharma, biotech, devices)
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 9 Aug 2023 (actual)
- Study completion
- 21 Mar 2024 (actual)
- First posted
- 28 Apr 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.
The goal of this study is to evaluate the safety of HH-101 antibody, administered as monotherapy to participants with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HH-101 Dose escalation (cohort 1) | Experimental | Drug: HH-101 (0.3 mg/kg) |
| HH-101 Dose escalation (cohort 2) | Experimental | Drug: HH-101 (1 mg/kg ) |
| HH-101 Dose escalation (cohort 3) | Experimental | Drug: HH-101 (3 mg/kg ) |
| HH-101 Dose escalation (cohort 4) | Experimental | Drug: HH-101 (10 mg/kg) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Voluntary signing of the written informed consent form;
- Histologic or cytologic confirmation of advanced solid tumor;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- Have an estimated life expectancy ≥3 Months, in the judgement of the investigator;
- Must have at least 1 measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Key exclusion criteria (8 listed)
- History of other malignancies within 5 years prior to the first dose of study drug, except for malignancies that have been cured after treatment, such as thyroid cancer, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of the breast.
- Receipt of the last systemic anti-tumor therapy within 2 weeks prior to the first dose of study drug, including chemotherapy, radiotherapy, targeted therapy, or traditional Chinese herbal medicine or patent Chinese medicines with anti-tumor activity. Patients who received tumor immune checkpoint inhibitor therapy within 4 weeks prior to the first dose of study drug.
- Adverse reactions from previous treatments that have not recovered to CTCAE v5.0 Grade 1 or lower (except for alopecia and neuropathy, which, in the Investigator's judgment, are long-standing and not expected to recover).
- Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
- If female, is pregnant, breastfeeding, or planning to become pregnant.
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 |
|---|---|---|
| HH-101 (0.3 mg/kg)Participants received 0.3 mg/kg HH-101 as an intravenous (IV) infusion on day (D)1 and D21 of each 21-day cycle every 3 weeks (Q3W). | Drug | HH-101 Dose escalation (cohort 1) |
| HH-101 (1 mg/kg )Participants received 1 mg/kg HH-101 as an intravenous (IV) infusion on day (D)1 and D21 of each 21-day cycle every 3 weeks (Q3W). | Drug | HH-101 Dose escalation (cohort 2) |
| HH-101 (3 mg/kg )Participants received 3 mg/kg HH-101 as an intravenous (IV) infusion on day (D)1 and D21 of each 21-day cycle every 3 weeks (Q3W). | Drug | HH-101 Dose escalation (cohort 3) |
| HH-101 (10 mg/kg)Participants received 10 mg/kg HH-101 as an intravenous (IV) infusion on day (D)1 and D21 of each 21-day cycle every 3 weeks (Q3W). | Drug | HH-101 Dose escalation (cohort 4) |
Primary outcome
Incidence of adverse events (AEs), serious adverse events (SAEs), and dose limiting toxicities (DLTs) per Common Terminology Criteria for Adverse Events v6.0 (CTCAE v5.0)
Time frame: Baseline through safety follow up completion (Up To 24 Months)
It will be assessed by the frequency, severity and nature of AEs, serious adverse event (SAE), changes in vital signs, physical examination, 12-lead ECG, laboratory tests (haematology, blood chemistry, urinalysis, coagulation Function, Thyroid Function Test and etc.), The severity of AEs will be graded by the NCI CTCAE version 5.0 and the AE terms will be coded by the current version of the Medical Dictionary for Regulatory Activities (MedDRA).
9 secondary outcomes
Area under the concentration-time curve (AUC)
Time frame: up to 24 months
Maximum observed plasma concentration (Cmax).
Time frame: up to 24 months
Time to reach Cmax (Tmax).
Time frame: up to 24 months
Terminal elimination half-life (t1/2).
Time frame: up to 24 months
Objective response rate (ORR)
Time frame: Baseline through Measured Progressive Disease (Up To 24 Months)
Disease control rate (DCR)
Time frame: Baseline through Measured Progressive Disease (Up To 24 Months)
Duration of response (DOR)
Time frame: Baseline through Measured Progressive Disease or death (Up To 24 Months)
progression-free survival (PFS)
Time frame: Baseline through Measured Progressive Disease or death (Up To 24 Months)
overall survival (OS)
Time frame: Baseline through the date of death from any cause (Up to 24 Months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HH-101 (0.3 mg/kg), HH-101 (1 mg/kg ) and HH-101 (3 mg/kg ) in people with Solid Tumor, run by Huahui Health at 1 site in China.
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 8 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: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs), serious adverse events (SAEs), and dose limiting toxicities (DLTs) per Common Terminology Criteria for Adverse Events v6.0 (CTCAE v5.0) (time frame: Baseline through safety follow up completion (Up To 24 Months)). 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 28 Apr 2026; AzTrials last refreshed its copy on 31 Oct 2026.