A Trial of SHR-A1921 for Injection in Subjects With Advanced Solid Tumors

Study Overview
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Brief Summary
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The study is being conducted to evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of SHR-1921.

Official Title
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An Open-Label, Multi-Center Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of SHR-A1921 for Injection in Subjects With Advanced Solid Tumors

Conditions
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Advanced Solid Tumor

Intervention / Treatment
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* Drug: SHR-1921


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able and willing to provide a written informed consent Subjects consented and willing to provide required tumor tissue of sufficient quantity and of adequate tumor tissue content Male or female Subjects with clinically or pathologically confirmed advanced (recurrent, unresectable or metastatic) solid tumors who have failed prior standard of care therapy ECOG performance status of 0-1 Exclusion Criteria: Has uncontrolled clinically symptomatic pleural effusion, pericardial effusion, carcinomatous ascites Has untreated brain metastasis, or with concomitant meningeal metastasis or spinal cord compression Has known history of other documented malignancy Has known history of acquired immunodeficiency syndrome (AIDS) Has significant cardiovascular disease that is not well controlled, such as: (1) New York Heart Association (NYHA) Grade ≥ 2 cardiac failure Has active or prior documented interstitial pneumonia/interstitial lung disease Has experienced Grade ≥ 2 hemorrhage events within 4 weeks prior to the first dose Has known active hepatitis B Has known allergies to SHR-1921 component Has other potential factors that may interfere with the study results, or result in the premature discontinuation as determined by the investigator.

Ages Eligible for Study
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Minimum Age: 18 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: SHR-1921 single arm study in pt. with Advance solid tumors
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHR-1921<br> | Drug: SHR-1921<br>* Subject will receive a single dose of SHR-1921 at dose level 1/2/3 on Day of each cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with adverse events (AEs) | To check the numbers of AEs happened during the course of trial. | Screening up to study completion, an average of 1 year | 
| Number of subjects with laboratory tests findings of potential clinical importance | To check the Clinically significant and non clinically significant abnormal values during the course of trial. | Screening up to study completion, an average of 1 year | 
| Incidence of vital sign abnormalities e.g. Systolic and Diastolic BP, Pulse rate. | To measure the vital signs on regular basis for all study participants | Screening up to study completion, an average of 1 year | 
| Measure ECG | Number of subjects with clinically significant abnormal ECG QT Interval | Screening up to study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) of SHR-1921 | To check what will be the maximum concentration participants will obtained of SHR-1921 in their blood plasma. | Screening up to study completion, an average of 1 year | 
| Area under the concentration-time curve (AUC 0-∞) from time 0 to infinity of SHR-1921 | To check the drug profile for absorption, distribution, metabolism and excretion for SHR-1921 in participants blood plasma | Screening up to study completion, an average of 1 year | 
| Time to Cmax (Tmax) of SHR-1921 | To check what time will it take to reach the maximum contraction of SHR-1921 in study participants | Screening up to study completion, an average of 1 year | 
| Clearance of SHR-1921 | The apparent clearance of SHR-1921(CL/F) of SHR-1921 | Screening up to study completion, an average of 1 year | 
| Terminal elimination half-life (t1/2) of SHR-1921 | To check how much time SHR-1921 will take to eliminate half of it's concentration from participants. | Screening up to study completion, an average of 1 year | 
| Pharmacodynamics (ADA ) of SHR-1921. | To check the Anti Drug Antibody develops in participants against the SHR-1921 through blood sample | Screening up to study completion, an average of 1 year |