A Trial of SHR-7367 in Subjects With Advanced Solid Tumors

Study Overview
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Brief Summary
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This is a dose-escalation and dose-expansion Phase 1 trial to evaluate the safety and tolerability of SHR-7367 in subjects with advanced solid tumors.

Official Title
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A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of SHR-7367 in Subjects With Advanced Solid Tumors

Conditions
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Advanced Solid Tumors

Intervention / Treatment
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* Drug: SHR-7367


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to understand and voluntarily agrees to participate by giving written informed consent for the study; Male or female aged ≥18 years and ≤75 years at the time of signing the ICF; Histopathologically or cytologically documented advanced or metastatic malignancies; At least 1 measurable lesion conforming to RECIST 1.1 criteria; An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1; Female and male patients of reproductive potential must agree to use highly effective contraception. Exclusion Criteria: Any immunostimulants administered within 4 weeks; Systemic anti-tumor therapy within 4 weeks; Any investigational cancer therapy administered within 4 weeks; Surgical procedures requiring general anesthesia within 4 weeks; History of autoimmune diseases; History of immunodeficiency; Severe infections within 2 weeks prior to the first study treatment; Clinically significant cardiovascular condition; Prior malignancy (other than current malignant tumor) within 5 ears before the first dose of study treatment; Known history of serious allergic reactions to the investigational product or its main ingredients.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: The study was divided into three phases, the dose escalation phase and the dose extension phase and therapeutic effect extension of SHR-7367 in subjects with advanced malignant tumors.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHR-7367<br> | Drug: SHR-7367<br>* The study was divided into three phases, the dose escalation phase and the dose extension phase and therapeutic effect extension of SHR-7367 in subjects with advanced malignant tumors.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-limiting toxicities (DLTs) | Number of participants with DLTs | Up to 3 weeks | 
| Recommended phase II dose | The Recommended phase II dose of SHR-7367 injection | first dose of study medication up to 21 days | 
| Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) | • Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response using RECIST 1.1 |  | From first dose to disease progression or death, whichever comes first, up to 12 months | 
| peak time (Tmax) |  | Up to 12 months | 
| peak concentration (Cmax) |  | Up to 12 months | 
| area under curve from 0 to the last measurable concentration time point t (AUC0-t), |  | Up to 12 months | 
| area under curve from 0 to infinity (AUC0-∞) |  | Up to 12 months | 
| elimination half-life (t1/2) |  | Up to 12 months | 
| clearance rate (CL) |  | Up to 12 months | 
| steady-state apparent volume of distribution (Vss) |  | Up to 12 months | 
| steady-state peak concentration (Cmax, ss) |  | Up to 12 months | 
| steady-state valley concentration (Ctrough, ss) |  | Up to 12 months | 
| accumulation ratio (Rac) |  | Up to 12 months | 
| percentage of activated B lymphocyte subsets in peripheral blood |  | Up to 12 months | 
| Immunogenicity index: drug-resistant antibody (ADA) |  | Up to 12 months | 
| Efficacy endpoints: Objective response rate (ORR) |  | Up to 12 months |