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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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05082545
Enrollment
19
Registered
2021-10-19
Start date
2021-11-23
Completion date
2024-02-12
Last updated
2024-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Malignant Tumors

Brief summary

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

Interventions

DRUGSHR-2002 and SHR-1316

Cohort study

Sponsors

Atridia Pty Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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;

Design outcomes

Primary

MeasureTime frameDescription
Adverse eventsScreening up to study completion, an average of 2 yearsNumber of subjects with adverse events (AEs)
Number of participants experiencing Dose-Limiting Toxicities (DLTs)Up to 42 daysAccording to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v.5.0)

Secondary

MeasureTime frameDescription
PK of SHR-2002 + SHR-1316Before and after SHR-2002 and SHR-1316 infusion throughout the study, an average of 2 yearsTo check Maximum concentration (Cmax)
Immunogenicity of SHR-2002 + SHR-1316Before and after SHR-2002 and SHR-1316 infusion throughout the study, an average of 2 yearsADA of SHR-2002 + SHR-1316

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026