An Open Label, Multicenter, Phase Ib/II Study of SHR-1802 in Combination With Adebrelimab in Patients With Advanced Solid Tumors

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to observe and evaluate the tolerability, safety, pharmacokinetics and immunogenicity of SHR-1802 combined with adebrelimab in patients with advanced solid tumors, determine the RP2D of SHR-1802 combined with adebrelimab ± chemotherapy, and evaluate the efficacy of SHR-1802 combined with adebrelimab ± chemotherapy in patients with advanced solid tumors.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
• Treatments: Carboplatin; Paclitaxel; Pemetrexed

Criteria

Inclusion Criteria:

1. Able and willing to provide a written informed consent；

2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;

3. Has a life expectancy≥ 12 weeks；

4. At least one measurable lesion according to RECIST v1.1；

5. Pathologically confirmed advanced solid tumor；

6. Adequate bone marrow reserve and organ function.

Exclusion Criteria:

1. Have received anti-PD-1 or PD-L1 antibody therapy;

2. Subjects with other malignant tumors in the past 3 years;

3. Have uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites;

4. Previous or current interstitial pneumonia/interstitial lung disease ;

5. History of autoimmune disease with the possibility of recurrence or active autoimmune disease;

6. Severe infection within 1 month before the first study drug administration;

7. The presence of other serious physical or mental disorders or abnormalities in laboratory tests that may increase the risk of study participation or interfere with study results, as well as patients deemed unsuitable for study participation by the investigator.