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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Advanced Malignant Tumors
• Intervention / Treatment: Drug: SHR-2002 and SHR-1316

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Kathy You; Phone Number: +61 02 9299 0433; Email: kathyyou@atridia.com
• Study Contact Backup: Name: Ravi Patel, M.Pharm; Phone Number: 0452363506; Email: ravi.patel@atridia.com

Study Locations

• Australia
  • Sydney, Australia, 2170
    • Liverpool Hospital
  • Sydney, Australia, 2031
    • Scientia Clinical Research
  • Queensland
    • Brisbane, Queensland, Australia, 4101
      • Icon Cancer Centre
  • Western Australia
    • Perth, Western Australia, Australia, 6009
      • Linear Clinical Research

Participation Criteria

Eligibility Criteria

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

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose escalation:SHR-2002+SHR-1316; SHR-2002 +SHR-1316 C1D1 SHR-2002,C1D22 SHR-2002+SHR-1316, C2 SHR-2002+SHR-1316	Drug: SHR-2002 and SHR-1316; Cohort study
Experimental: Dose expansion stage: SHR-2002+SHR-1316; Dose expansion of SHR-2002 will be decided after finishing few cohorts in Dose escalation part.	Drug: SHR-2002 and SHR-1316; Cohort study
Experimental: Indication expansion stage：SHR-2002+SHR-1316; Indication expansion of SHR-2002 will be decided after finishing few cohorts in Dose expansion part.	Drug: SHR-2002 and SHR-1316; Cohort study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Number of subjects with adverse events (AEs)	Screening up to study completion, an average of 2 years
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Atridia Pty Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2021
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: September 15, 2021
• First Submitted That Met QC Criteria: October 5, 2021
• First Posted (Actual): October 19, 2021

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: SHR-2002-102; SHR-2002-I-102 (Other Identifier: Jiangsu Hengrui Pharmaceuticals Ltd.)

Drug and device information, study documents

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