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
Overview
- Phase
- Phase 1
- Intervention
- SHR-1921
- Conditions
- Advanced Solid Tumor
- Sponsor
- Atridia Pty Ltd.
- Enrollment
- 9
- Locations
- 4
- Primary Endpoint
- Number of subjects with laboratory tests findings of potential clinical importance
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The study is being conducted to evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of SHR-1921.
Investigators
Eligibility Criteria
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.
Arms & Interventions
SHR-1921
Intervention: SHR-1921
Outcomes
Primary Outcomes
Number of subjects with laboratory tests findings of potential clinical importance
Time Frame: Screening up to study completion, an average of 1 year
To check the Clinically significant and non clinically significant abnormal values during the course of trial.
Incidence of vital sign abnormalities e.g. Systolic and Diastolic BP, Pulse rate.
Time Frame: Screening up to study completion, an average of 1 year
To measure the vital signs on regular basis for all study participants
Measure ECG
Time Frame: Screening up to study completion, an average of 1 year
Number of subjects with clinically significant abnormal ECG QT Interval
Number of subjects with adverse events (AEs)
Time Frame: Screening up to study completion, an average of 1 year
To check the numbers of AEs happened during the course of trial.
Secondary Outcomes
- Maximum observed plasma concentration (Cmax) of SHR-1921(Screening up to study completion, an average of 1 year)
- Clearance of SHR-1921(Screening up to study completion, an average of 1 year)
- Terminal elimination half-life (t1/2) of SHR-1921(Screening up to study completion, an average of 1 year)
- Pharmacodynamics ("ADA" ) of SHR-1921.(Screening up to study completion, an average of 1 year)
- Time to Cmax (Tmax) of SHR-1921(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(Screening up to study completion, an average of 1 year)