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

NCT06992713 | Recruiting Phase 1

• 1 other identifier: H1710-002
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (4)

• Incidence and severity of treatment-emergent adverse events

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

  Up to ~ 18 months

• Dose Limiting Toxicities（DLT）

  Up to ~ 18 months

• Maximum Tolerated Dose (MTD)

  Up to ~ 18 months

• Recommended Phase 2 Dose (RP2D)

  Up to ~ 18 months

Secondary Outcomes (9)

• Maximum Observed Concentration(Cmax) of H1710

  Up to ~ 18 months

• Time of Maximum Concentration (Tmax)of H1710

  Up to ~ 18 months

• Area Under the Concentration (AUC) of H1710

  Up to ~ 18 months

• Terminal Half life( t½) of H1710

  Up to ~ 18 months

• Clearance (CL) of H1710

  Up to ~ 18 months

Study Arms (1)

H1710 for Injection

EXPERIMENTAL

Participants receive H1710 for Injection according to the protocol.

Drug: H1710 for Injection

Interventions

H1710 for Injection DRUG

Injection.

Also known as: H1710

H1710 for Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Shenzhen Hepalink Pharmaceutical Group Co., Ltd.: lead

Study Sites (3)

Beijing Cancer Hospital

Beijing, 100142, China

RECRUITING

Peking University Shougang Hospital

Beijing, 100144, China

RECRUITING

Shanghai East Hospital

Shanghai, China

RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 28, 2025
• Study Start: June 18, 2025
• Primary Completion (Estimated): September 4, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: July 23, 2025

Record last verified: 2025-07

Locations

CN (3)