Actively Recruiting
A Phase Ia First-in-human Clinical Study of the Safety, Tolerability, and Pharmacokinetics of H1710 for Injection in Participants With Advanced Solid Tumors
Led by Shenzhen Hepalink Pharmaceutical Group Co., Ltd. · Updated on 2025-07-23
36
Participants Needed
3
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and how the body processes H1710 for Injection in adults with advanced solid tumors. This early phase study focuses on participants whose tumors have not responded to standard treatments or who have no standard treatment options. The trial aims to determine safe dosage levels and understand potential side effects. Participants will receive H1710 for Injection following the study protocol. The trial includes monitoring for dose-limiting toxicities and determining the maximum tolerated dose. Treatment and assessments will continue for up to about 18 months to establish the recommended dose for future studies. During the study, participants will undergo regular evaluations including monitoring for adverse events, tumor response using established criteria, and blood tests to measure drug levels and effects. Researchers will track safety outcomes, disease control, and progression-free survival. Participants are expected to be involved for up to 18 months with periodic visits and tests throughout the study period.
CONDITIONS
Brief Title
A Clinical Study Evaluating H1710 for Injection in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years, any gender, ethnicity, financial, or educational background
- Signed informed consent before screening
- Histologically or cytologically confirmed advanced solid tumors with failed standard treatment, no standard treatment, or intolerance to standard treatments
- Measurable or evaluable tumor lesions by RECIST version 1.1
- ECOG performance status of 0 or 1
- Predicted life expectancy of at least 3 months
- Adequate bone marrow and organ function within 7 days before first dose of H1710
You will not qualify if you...
- Tumor lesions with high risk of bleeding
- Active significant bleeding or high risk of hemorrhage
- Major surgery, intervention, or significant trauma within 28 days before first dose, or planned elective surgery during trial
- Spinal, epidural, or loco-regional anesthesia within 24 hours before first dose
- Primary brain tumors or active brain/meningeal metastases needing medical intervention within 28 days before first dose
- Poorly controlled pleural, pericardial effusion, or ascites needing repeated drainage
- Anti-tumor therapy within 28 days before first dose, unless judged eligible
- Another active invasive malignancy unless judged eligible
- Symptomatic congestive heart failure, unstable angina, sinus bradycardia, uncontrolled hypertension, or ongoing arrhythmia
- Uncontrolled diabetes
- History of significant interstitial lung disease or pneumonia
- Recent myocardial infarction, coronary stenting, or arterial thromboembolic events within specified timeframes
- Live attenuated vaccine within 28 days before first dose or planned during study without approval
- HIV infection, active hepatitis B or C infection unless judged eligible
- Active infections requiring antibiotics within 14 days before first dose
- Unresolved prior anti-tumor therapy adverse events above Grade 1 except specific non-safety risks
- Participation in other investigational drug studies within specific washout periods
- Pregnant or lactating females or those planning pregnancy during and 6 months after treatment
- Participants refusing reliable birth control during and 6 months after treatment
- Any psychiatric, social, or medical condition increasing risk or interfering with consent or protocol adherence
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 18 months
Participants receive H1710 for Injection according to the protocol to evaluate safety, tolerability, and pharmacokinetics.
Visits as required for dosing and safety assessments during treatment
Trial Site Locations
Total: 3 locations
1
Beijing Cancer Hospital
Beijing, China, 100142
Actively Recruiting
2
Peking University Shougang Hospital
Beijing, China, 100144
Actively Recruiting
3
Shanghai East Hospital
Shanghai, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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