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

Atridia

Status and phase: Completed; Phase 1

Conditions: Advanced Malignant Tumors

Treatments: Drug: SHR-2002 and SHR-1316

Study type: Interventional

Funder types: Industry

Identifiers

NCT05082545

SHR-2002-102

SHR-2002-I-102 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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;

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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19 participants in 3 patient groups

Dose escalation:SHR-2002+SHR-1316

Experimental group

Description:

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

Treatment:

Drug: SHR-2002 and SHR-1316

Dose expansion stage: SHR-2002+SHR-1316

Experimental group

Description:

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

Treatment:

Drug: SHR-2002 and SHR-1316

Indication expansion stage：SHR-2002+SHR-1316

Experimental group

Description:

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

Treatment:

Drug: SHR-2002 and SHR-1316