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

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

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

Study Overview

• Status: Completed
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: SHR-1921

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2031
      • Scientia Clinical Research
    • Sydney, New South Wales, Australia, 2109
      • Macquarie Hospital
    • Sydney, New South Wales, Australia, 2170
      • Sydney South West Private Hospital
  • Queensland
    • Brisbane, Queensland, Australia, 4101
      • Icon Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Atridia Pty Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): April 24, 2024
• Study Completion (Actual): April 24, 2024

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: October 24, 2022
• First Posted (Actual): October 26, 2022

Study Record Updates

• Last Update Posted (Actual): June 25, 2024
• Last Update Submitted That Met QC Criteria: June 23, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: SHR-A1921-I-102-AUS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No