A Phase 1 interventional study of HG381 in Advanced Solid Tumor, sponsored by HitGen Inc.. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by HitGen Inc. · Phase 1, Interventional, and Treatment
This is a Phase I, first in human, open-label, non-randomized, multicenter study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, preliminary efficacy and establish a recommended dose of HG381 administered intravenously (IV) alone in subjects with advanced solid tumors.
The trial consists of a dose escalation phase and a cohort expansion phase.In dose escalation phase, escalating doses of HG381 will be evaluated as guided by the traditional 3+3 design . In cohort expansion phase, subjects will receive HG381 alone at a single dose level determined based on the data form dose escalation phase. In total, approximately 57 subjects will participate in the study, approximately 42 in the dose-escalation cohort, and approximately 15 in the expansion cohort.
Exclusion Criteria:
Subjects will receive HG381 IV at every one week intervals (Q1W). Escalating doses of HG381 will be evaluated by the traditional 3+3 design.
Drug: HG381
Subjects will be administered the recommended Phase 2 dose of HG381 IV Q1W established in Part A of the study.
Drug: HG381
HG381 is available as white to off-white cake or powder for solution for injection at a unit dose strength of 5 mg per vial. HG381 will be administered as IV injection.
Also known as: HG381 for Injection
Number of subjects achieving Dose-limiting toxicity (DLT)
DLT is defined as an adverse event (AE) that meets protocol defined DLT criteria during cycle 1 and is at least possibly related to study drug.
Time frame: Up to Day 21
Maximum Tolerated Dose (MTD)
The maximum tolerated dose (MTD) is defined as the maximum dose where the number of cases of DLT ≤ 1/6 of the total number of cases during the DLT observation period. At least 6 evaluable subjects are required to determine MTD.
Time frame: Up to 12 months
Number of subjects with adverse events (AEs) and serious adverse events (SAEs)
An AE is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or requires medical judgement.
Time frame: Up to 24 months
Severity of AEs
The severity of AEs will be graded utilizing the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0.
Time frame: Up to 24 months
Recommended Phase 2 Dose (RP2D) of HG381
Up to 42 patients with advanced/metastatic solid tumors will be enrolled in Dose Escalation to determine the RP2D of HG381 as monotherapy.
Time frame: Up to 12 months
Best objective response based on RECIST 1.1
Best objective response rate is defined as the percentage of subjects with a best overall confirmed CR or PR at any time as per disease-specific criteria.
Time frame: Up to 24 months
HG381 concentrations in plasma following administration of HG381 alone
Blood samples will be collected at indicated time points for plasma pharmacokinetic (PK) analysis of HG381.
Time frame: Cycle 1 Days 1, Cycle 2 Days 1 and Cycle 3 Days 1: pre-infusion and at multiple time points (up to 24 hours) post-infusion (Cycle length=21 days)
Maximum observed concentration (Cmax) following administration of HG381 alone
Blood samples will be collected at indicated time points for plasma PK analysis following administration of HG381 monotherapy.
Time frame: Cycle 1 Days 1, Cycle 2 Days 1 and Cycle 3 Days 1: pre-infusion and at multiple time points (up to 24 hours) post-infusion (Cycle length=21 days)
Area under the concentration-time curve (AUC) following administration of HG381 alone
Blood samples will be collected at indicated time points for plasma PK analysis following administration of HG381 monotherapy.
Time frame: Cycle 1 Days 1, Cycle 2 Days 1 and Cycle 3 Days 1: pre-infusion and at multiple time points (up to 24 hours) post-infusion (Cycle length=21 days)
Apparent terminal phase half-life (t½) following administration of HG381 alone
Blood samples will be collected at indicated time points for plasma PK analysis following administration of HG381 monotherapy.
Time frame: Cycle 1 Days 1, Cycle 2 Days 1 and Cycle 3 Days 1: pre-infusion and at multiple time points (up to 24 hours) post-infusion (Cycle length=21 days)
Plan to share: No
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HitGen Inc.