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

NCT ID: NCT05082545

Last Updated: 2024-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-23
• Study Completion Date: 2024-02-12

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose escalation:SHR-2002+SHR-1316

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

Group Type: EXPERIMENTAL

SHR-2002 and SHR-1316

Intervention Type: DRUG

Cohort study

Dose expansion stage: SHR-2002+SHR-1316

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

Group Type: EXPERIMENTAL

SHR-2002 and SHR-1316

Intervention Type: DRUG

Cohort study

Indication expansion stage：SHR-2002+SHR-1316

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

Group Type: EXPERIMENTAL

SHR-2002 and SHR-1316

Intervention Type: DRUG

Cohort study

Interventions

SHR-2002 and SHR-1316

Cohort study

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Atridia Pty Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Icon Cancer Centre

Brisbane, Queensland, Australia

Linear clinical research

Perth, Western Australia, Australia

Scientia Clinical research

Sydney, , Australia

Liverpool Hospital

Sydney, , Australia

Countries

Australia

Other Identifiers

SHR-2002-I-102

Identifier Type: OTHER

Identifier Source: secondary_id

SHR-2002-102

Identifier Type: -

Identifier Source: org_study_id