Clinical trial NCT05082545: Phase I Study of SHR-2002 + SHR-1316 in Patients With Advanced Malignant Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Malignant Tumors
Lead sponsor: Atridia Pty Ltd.
Sponsor class: INDUSTRY
First posted: 2021-10-19
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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;

Primary outcomes:
measure: Adverse events
timeFrame: Screening up to study completion, an average of 2 years
measure: Number of participants experiencing Dose-Limiting Toxicities (DLTs)
timeFrame: Up to 42 days
Secondary outcomes:
measure: PK of SHR-2002 + SHR-1316
timeFrame: Before and after SHR-2002 and SHR-1316 infusion throughout the study, an average of 2 years
measure: PK of SHR-2002 + SHR-1316
timeFrame: Before and after SHR-2002 and SHR-1316 infusion throughout the study, an average of 2 years
measure: Immunogenicity of SHR-2002 + SHR-1316
timeFrame: Before and after SHR-2002 and SHR-1316 infusion throughout the study, an average of 2 years
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Icon Cancer Centre
state: Queensland
city: Perth
country: Australia
facility: Linear clinical research
state: Western Australia
city: Sydney
country: Australia
facility: Scientia Clinical research
city: Sydney
country: Australia
facility: Liverpool Hospital
Study officials:
References: