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

NCT05082545 | Completed Phase 1 DMC

• 2 other identifiers: SHR-2002-102SHR-2002-I-102
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Advanced Malignant Tumors

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• PK of SHR-2002 + SHR-1316

  Before and after SHR-2002 and SHR-1316 infusion throughout the study, an average of 2 years

• PK of SHR-2002 + SHR-1316

  Before and after SHR-2002 and SHR-1316 infusion throughout the study, an average of 2 years

• Immunogenicity of SHR-2002 + SHR-1316

  Before and after SHR-2002 and SHR-1316 infusion throughout the study, an average of 2 years

Study Arms (3)

Dose escalation:SHR-2002+SHR-1316

EXPERIMENTAL

SHR-2002 +SHR-1316 C1D1 SHR-2002,C1D22 SHR-2002+SHR-1316, C2 SHR-2002+SHR-1316

Drug: SHR-2002 and SHR-1316

Dose expansion stage: SHR-2002+SHR-1316

EXPERIMENTAL

Dose expansion of SHR-2002 will be decided after finishing few cohorts in Dose escalation part.

Drug: SHR-2002 and SHR-1316

Indication expansion stage：SHR-2002+SHR-1316

EXPERIMENTAL

Indication expansion of SHR-2002 will be decided after finishing few cohorts in Dose expansion part.

Drug: SHR-2002 and SHR-1316

Interventions

SHR-2002 and SHR-1316 DRUG

Cohort study

Dose escalation:SHR-2002+SHR-1316; Dose expansion stage: SHR-2002+SHR-1316; Indication expansion stage：SHR-2002+SHR-1316

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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;

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Atridia Pty Ltd.: lead

Study Sites (4)

Icon Cancer Centre

Brisbane, Queensland, 4101, Australia

Location

Linear clinical research

Perth, Western Australia, 6009, Australia

Location

Scientia Clinical research

Sydney, 2031, Australia

Location

Liverpool Hospital

Sydney, 2170, Australia

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: October 19, 2021
• Study Start: November 23, 2021
• Primary Completion: July 17, 2023
• Study Completion: February 12, 2024
• Last Updated: June 4, 2024

Record last verified: 2023-12

Locations

AU (4)