Phase I Study of SHR-2002 + SHR-1316 in Patients With Advanced Malignant Tumors

Advanced Malignant Tumors Clinical Trial

Official title:

A Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SHR-2002 Injection in Combination With SHR-1316 in Patients With Advanced Malignant Tumors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05082545
• Other study ID #: SHR-2002-102
• Secondary ID: SHR-2002-I-102
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: November 23, 2021
• Est. completion date: September 2025

Study information

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

Clinical Trial Summary

This is Phase 1 study FIH to check "Dose Escalation, Dose expansion and Indication expansion". This study is AUSTRALIA only study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: September 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Subjects must meet all the following criteria to be eligible for enrollment into the study:

1. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;

2. Male or female aged =18 years at the time of signing the ICF;

3. Histopathologically or cytologically documented advanced or metastatic malignancies and failed or intolerable to previous standard therapy, has no available standard of care therapy or refused standard therapy;

4. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1 (Appendix 2);

5. Female and male patients of reproductive potential must agree to use highly effective contraception during the study treatment period and within 6 months after the last investigational drug administration.

Subjects who meet any of the following criteria will be excluded from the study:

1. Patients with known active central nervous system (CNS) metastases and/or carcinomatous meningitis.

2. Patients with tumor-related pain that cannot be controlled as determined by the investigator.

3. Systemic anti-tumor therapy within 28 days prior to the first dose of the study treatment

4. History of autoimmune diseases, except for Type 1 diabetes (blood glucose can be controlled by insulin therapy)

5. History of clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to the first dose of study treatment.

6. Known history of serious allergic reactions to the investigational product or its main ingredients;

7. History of immunodeficiency, including positive HIV serum test result and other acquired or congenital immunodeficiency diseases, or history of organ transplantation;

Related Conditions & MeSH terms

• Advanced Malignant Tumors
• Neoplasms

Intervention

Drug:
• SHR-2002 and SHR-1316
Cohort study

Locations

Country	Name	City	State
Australia	Icon Cancer Centre	Brisbane	Queensland
Australia	Linear clinical research	Perth	Western Australia
Australia	Liverpool Hospital	Sydney
Australia	Scientia Clinical research	Sydney

Sponsors (1)

Lead Sponsor	Collaborator
Atridia Pty Ltd.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	Number of subjects with adverse events (AEs)	Screening up to study completion, an average of 2 years
Primary	Number of participants experiencing Dose-Limiting Toxicities (DLTs)	According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v.5.0)	Up to 42 days
Secondary	PK of SHR-2002 + SHR-1316	To check Maximum concentration (Cmax)	Before and after SHR-2002 and SHR-1316 infusion throughout the study, an average of 2 years
Secondary	PK of SHR-2002 + SHR-1316	To check AUC last	Before and after SHR-2002 and SHR-1316 infusion throughout the study, an average of 2 years
Secondary	Immunogenicity of SHR-2002 + SHR-1316	ADA of SHR-2002 + SHR-1316	Before and after SHR-2002 and SHR-1316 infusion throughout the study, an average of 2 years