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Advanced Solid TumorPhase 1NCT06992713

A Clinical Study Evaluating H1710 for Injection in Participants With Advanced Solid Tumors

A Phase 1 study testing H1710 for Injection in people with Advanced Solid Tumor, run by Shenzhen Hepalink Pharmaceutical Group Co., Ltd. at 4 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a phase Ia clinical study evaluating H1710 for Injection in Participants with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumor
What is being tested?
H1710 for Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
4 sitesChina
Study dates
18 Jun 2025to 30 Nov 2026
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 18 years≤ age ≤ 75 years, irrespective of gender, ethnicity, financial, and educational background.
  • Signed Informed Consent Form (ICF) prior to screening.
  • Participants with histologically or cytologically confirmed advanced solid tumors, who have failed standard treatment, or have no standard treatment, or intolerant to or not suitable for standard treatment.
  • Participants must have measurable or evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Predicted life expectancy of at least 3 months.
  • Adequate bone marrow reserve and organ function within 7 days prior to first dose of H1710.

Who cannot join

  • Presence of malignant tumor lesion(s) that is/are at high risk of bleeding as judged by the clinical study investigator.
  • Active clinically significant bleeding or conditions with a high risk of hemorrhage.
  • Major surgery or interventional therapy or significant trauma within 28 days prior to the first dose of H1710, or elective surgery during the clinical trial period.
  • Spinal or epidural anesthesia or loco-regional anesthesia within 24 hours prior to the first dose of H1710.
  • Primary brain tumors. Active brain/meningeal metastases or central nervous system involvement who have clinical symptoms requiring medical intervention within 28 days prior to the first dose of H1710.
  • Poorly controlled pleural effusion, pericardial effusion or ascites requiring repeated drainage as determined by investigators to be unsuitable for inclusion.
Show all 19Show fewer
  • Any anti-tumor therapy within 28 days prior to first dose of H1710, except for those who can be included after judgment by investigators.
  • Participants have another active invasive malignancy, except for those who can be included after judgment by investigators.
  • Symptomatic congestive heart failure, unstable angina, sinus bradycardia, clinically uncontrollable hypertension, and ongoing cardiac arrhythmia.
  • Uncontrolled diabetes as determined by investigators.
  • History of clinically significant interstitial lung disease or pneumonia as determined by investigators.
  • Participants have a history of myocardial infarction within 6 months or coronary stenting within 12 months or a history of arterial thromboembolic event within 3 months before the first dose of H1710.
  • Participants received a live attenuated vaccine within 28 days before the first dose of H1710 and/or plan to receive live vaccines during the study period unless approved by the clinical investigator and Sponsor.
  • Human immunodeficiency virus (HIV) infection or HIV positive, active Hepatitis B Virus (HBV) infection, active Hepatitis C Virus (HCV) infection. Except those who can be included after judgment by investigators.
  • Participants who have active bacterial, fungal or viral (except hepatitis virus) infections within 14 days before the first dose of H1710 and require intravenous or oral administration of antibiotics and/or other anti-infective therapeutic drugs.
  • Any adverse events due to prior anti-tumor therapy unresolved to ≤ Grade 1 of CTCAE 5.0 (except for toxicities judged by the clinical investigator to be of no safety risk, such as alopecia, other long term ≤ Grade 2 toxicities which would not impact the administration of H1710 and safety evaluation).
  • Participation in a clinical study of biological drug within 28 days, or within 14 days or 5 half-lives for small-molecule agents, before first dose of H1710, or current participation in other therapeutic investigational clinical trials.
  • Females who are pregnant or lactating or who intend to become pregnant during the clinical trial period and within 6 months after discontinuation of H1710 treatment. Female or Male who refuse using reliable birth control methods during the clinical trial period and within 6 months after discontinuation of H1710.
  • Participants who have any clinically significant psychiatric, social, or medical condition that, as judged by the clinical investigator, could increase the subject's risk, interfere with protocol adherence, or affect the subject's ability to give informed consent are ineligible to participate in the study.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

China4 sites, 4 recruiting

  • Beijing Cancer Hospital

    Beijing, 100142

    Lin Shen, MD, 0086-10-88196561, doctorshenlin@sina.com

    Recruiting

  • Peking University Shougang Hospital

    Beijing, 100144

    Jin Gu, MD, 0086-10-57830000, zlgujin@126.com

    Recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

    Yongmei Yin, MD, 0086-25-83714511, ym.yin@hotmail.com

    Not yet recruiting

  • Shanghai East Hospital

    Shanghai

    Wei Li, MD, 0086-21-38804518, leewluck@gmail.com

    Recruiting

Other trials in China

About this study

Official title: A Phase Ia, First-in-human, Clinical Study of the Safety, Tolerability, and Pharmacokinetics of H1710 for Injection in Participants With Advanced Solid Tumors

This is a phase Ia clinical study evaluating H1710 for Injection in Participants with advanced solid tumors.

Read the detailed description

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of H1710 for Injection in participants with advanced solid tumors.

Being tested
H1710 for Injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • H1710 for InjectionDrug

    Also called H1710

    Injection.

Study groups in NCT06992713
Study groupRoleWhat they receive
H1710 for InjectionExperimentalParticipants receive H1710 for Injection according to the protocol.
Receives: Drug: H1710 for Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and severity of treatment-emergent adverse events

    Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE Version 5.0

    Measured: Up to ~ 18 months

  2. Dose Limiting Toxicities（DLT）

    Measured: Up to ~ 18 months

  3. Maximum Tolerated Dose (MTD)

    Measured: Up to ~ 18 months

  4. Recommended Phase 2 Dose (RP2D)

    Measured: Up to ~ 18 months

Secondary outcomes (9)

  1. Maximum Observed Concentration(Cmax) of H1710

    Blood samples will be collected to determine the Cmax of H1710.

    Measured: Up to ~ 18 months

  2. Time of Maximum Concentration (Tmax)of H1710

    Time to reach H1710 maximum observed concentration

    Measured: Up to ~ 18 months

  3. Area Under the Concentration (AUC) of H1710

    Blood samples will be collected to determine the AUC of H1710.

    Measured: Up to ~ 18 months

  4. Terminal Half life( t½) of H1710

    Blood samples will be collected to determine the terminal half-life of H1710.

    Measured: Up to ~ 18 months

  5. Clearance (CL) of H1710

    Blood samples will be collected to determine the CL of H1710.

    Measured: Up to ~ 18 months

  6. Objective Response Rate (ORR)

    Percentage of participants with best response of complete response (CR) or partial response (PR).

    Measured: Up to ~ 18 months

  7. Disease Control Rate(DCR)

    The proportion of participants with best overall response of complete response(CR) or partial response(PR) or disease stabilization(SD) after treatment.

    Measured: Up to ~ 18 months

  8. Duration of Response (DOR)

    Time from complete response(CR) or partial response(PR) to objective disease progression or death to any cause.

    Measured: Up to ~ 18 months]

  9. Progression Free Survival (PFS)

    The time from the start of the treatment until objective disease progression or death from any cause.

    Measured: Up to ~ 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2025
  2. Study start18 Jun 2025
  3. Primary completion4 Sep 2026 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06992713
Sponsor's protocol ID
H1710-002
Status last verified
Jun 2026
First submitted
9 May 2025
Last updated
18 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing H1710 for Injection in people with Advanced Solid Tumor, run by Shenzhen Hepalink Pharmaceutical Group Co., Ltd. at 4 sites 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 7 inclusion and 19 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 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of treatment-emergent adverse events (time frame: Up to ~ 18 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?

On the ClinicalTrials.gov record for NCT06992713.

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 18 Jun 2026.

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