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

Advanced Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05594875
• Other study ID #: SHR-A1921-I-102-AUS
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: December 1, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: December 2023
• Source: Atridia Pty Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 9
• Est. completion date: July 31, 2024
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• SHR-1921
Subject will receive a single dose of SHR-1921 at dose level 1/2/3 on Day of each cycles

Locations

Country	Name	City	State
Australia	ICON Cancer Centre	Brisbane	Queensland
Australia	Macquarie Hospital	Sydney	New South Wales
Australia	Scientia Clinical Research	Sydney	New South Wales
Australia	Sydney South West Private Hospital	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Atridia Pty Ltd.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Measure ECG	Number of subjects with clinically significant abnormal ECG QT Interval	Screening up to study completion, an average of 1 year
Secondary	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
Secondary	Area under the concentration-time curve (AUC 0-8) 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
Secondary	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
Secondary	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
Secondary	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
Secondary	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