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

Phase 1

Completed

• Conditions: Advanced Malignant Tumors
• Interventions: Drug: SHR-2002 and SHR-1316

• Registration Number: NCT05082545
• Lead Sponsor: Atridia Pty Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-15
• Study First Submitted QC: 2021-10-05
• Study First Posted: 2021-10-19
• Study Start: 2021-11-23
• Primary Completion: 2023-07-17
• Status Verified: 2023-12
• Study Completion: 2024-02-12
• Last Update Submitted: 2024-06-02
• Last Update Posted: 2024-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose escalation:SHR-2002+SHR-1316	SHR-2002 and SHR-1316	SHR-2002 +SHR-1316 C1D1 SHR-2002,C1D22 SHR-2002+SHR-1316, C2 SHR-2002+SHR-1316
Dose expansion stage: SHR-2002+SHR-1316	SHR-2002 and SHR-1316	Dose expansion of SHR-2002 will be decided after finishing few cohorts in Dose escalation part.
Indication expansion stage：SHR-2002+SHR-1316	SHR-2002 and SHR-1316	Indication expansion of SHR-2002 will be decided after finishing few cohorts in Dose expansion part.

Primary Outcome Measures

Name	Time	Method
Adverse events	Screening up to study completion, an average of 2 years	Number of subjects with adverse events (AEs)
Number of participants experiencing Dose-Limiting Toxicities (DLTs)	Up to 42 days	According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v.5.0)

Secondary Outcome Measures

Name	Time	Method
PK of SHR-2002 + SHR-1316	Before and after SHR-2002 and SHR-1316 infusion throughout the study, an average of 2 years	To check AUC last
Immunogenicity of SHR-2002 + SHR-1316	Before and after SHR-2002 and SHR-1316 infusion throughout the study, an average of 2 years	ADA of SHR-2002 + SHR-1316

Trial Locations

Locations (4)

Icon Cancer Centre; 🇦🇺 Brisbane, Queensland, Australia

Liverpool Hospital; 🇦🇺 Sydney, Australia

Linear clinical research; 🇦🇺 Perth, Western Australia, Australia

Scientia Clinical research; 🇦🇺 Sydney, Australia