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

Phase 1

Completed

• Conditions: Advanced Solid Tumor
• Interventions: Drug: SHR-1921

• Registration Number: NCT05594875
• Lead Sponsor: Atridia Pty Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-18
• Study First Submitted QC: 2022-10-24
• Study First Posted: 2022-10-26
• Study Start: 2022-12-01
• Status Verified: 2023-12
• Primary Completion: 2024-04-24
• Study Completion: 2024-04-24
• Last Update Submitted: 2024-06-23
• Last Update Posted: 2024-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

1. Able and willing to provide a written informed consent
2. Subjects consented and willing to provide required tumor tissue of sufficient quantity and of adequate tumor tissue content
3. Male or female
4. Subjects with clinically or pathologically confirmed advanced (recurrent, unresectable or metastatic) solid tumors who have failed prior standard of care therapy
5. ECOG performance status of 0-1

Exclusion Criteria

1. Has uncontrolled clinically symptomatic pleural effusion, pericardial effusion, carcinomatous ascites
2. Has untreated brain metastasis, or with concomitant meningeal metastasis or spinal cord compression
3. Has known history of other documented malignancy
4. Has known history of acquired immunodeficiency syndrome (AIDS)
5. Has significant cardiovascular disease that is not well controlled, such as: (1) New York Heart Association (NYHA) Grade ≥ 2 cardiac failure
6. Has active or prior documented interstitial pneumonia/interstitial lung disease
7. Has experienced Grade ≥ 2 hemorrhage events within 4 weeks prior to the first dose
8. Has known active hepatitis B
9. Has known allergies to SHR-1921 component
10. Has other potential factors that may interfere with the study results, or result in the premature discontinuation as determined by the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SHR-1921	SHR-1921	-

Primary Outcome Measures

Name	Time	Method
Number of subjects with laboratory tests findings of potential clinical importance	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.	Screening up to study completion, an average of 1 year	To measure the vital signs on regular basis for all study participants
Measure ECG	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)	Screening up to study completion, an average of 1 year	To check the numbers of AEs happened during the course of trial.

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Scientia Clinical Research; 🇦🇺 Sydney, New South Wales, Australia

Macquarie Hospital; 🇦🇺 Sydney, New South Wales, Australia

Sydney South West Private Hospital; 🇦🇺 Sydney, New South Wales, Australia

ICON Cancer Centre; 🇦🇺 Brisbane, Queensland, Australia