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

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

Overview

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

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.

Interventions

• Drug H1710 for Injection
  Injection.

Primary outcome measures

• Incidence and severity of treatment-emergent adverse events [Time frame: Up to ~ 18 months]
• Dose Limiting Toxicities（DLT） [Time frame: Up to ~ 18 months]
• Maximum Tolerated Dose (MTD) [Time frame: Up to ~ 18 months]
• Recommended Phase 2 Dose (RP2D) [Time frame: Up to ~ 18 months]

Secondary outcome measures (9)

• Maximum Observed Concentration(Cmax) of H1710 [Time frame: Up to ~ 18 months]
• Time of Maximum Concentration (Tmax)of H1710 [Time frame: Up to ~ 18 months]
• Area Under the Concentration (AUC) of H1710 [Time frame: Up to ~ 18 months]
• Terminal Half life( t½) of H1710 [Time frame: Up to ~ 18 months]
• Clearance (CL) of H1710 [Time frame: Up to ~ 18 months]
• Objective Response Rate (ORR) [Time frame: Up to ~ 18 months]
• Disease Control Rate(DCR) [Time frame: Up to ~ 18 months]
• Duration of Response (DOR) [Time frame: Up to ~ 18 months]]
• Progression Free Survival (PFS) [Time frame: Up to ~ 18 months]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 4 centers

• Jiangsu Province Hospital — Nanjing
• Beijing Cancer Hospital — Beijing
• Peking University Shougang Hospital — Beijing
• Shanghai East Hospital — Shanghai

Identifiers

NCT: NCT06992713 · H1710-002

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗