A Study of HG381 Administered to Patients With Advanced Solid Tumors
ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHitGen Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Capable of giving signed informed consent.
Life expectancy of at least 3 months.
Histological or cytological documentation of an advanced solid tumor，subjects with advanced/recurrent solid tumors, who have progressed on, be intolerant of, or ineligible for, all available therapies for which clinical benefit has been established.
Measurable disease per RECIST version 1.1, there is at least one measurable lesion during the screening period.
Disqualifiers
Chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy and other anticancer therapy within 4 weeks.
Concurrent medical condition requiring the use of other systemic immunosuppressive treatment within 4 weeks before the first dose of study treatment.
Receipt of any live vaccine within 4 weeks of the start of study treatment.
Receipt of unmarketed clinical trial drugs or treatments within 4 weeks of the start of study treatment.
Trial design
Design model
Sequential
Treatments tested in this trial
HG381
DrugHG381 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.
Treatment groups
57 Participants
are divided into 2 treatment groupsGroup A: Part A: HG381 Monotherapy Dose Escalation CohortExperimental treatment 1 intervention
Group B: Part B: HG381 Monotherapy Dose Expansion CohortExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 212
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 months3
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 months4
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 monthsSecondary outcomes
1
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 months2
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 months3
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)4
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)Sponsors and contacts
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Source ClinicalTrials.gov