A Study of SHR-1802 in Combination With Adebrelimab in Patients With Advanced Solid Tumors
- Conditions
- Advanced Solid Tumor
- Interventions
- Biological: AdebrelimabBiological: SHR-1802Drug: Carboplatin/CisplatinDrug: Paclitaxel/Nab-Paclitaxel/Pemetrexed
- Registration Number
- NCT05794477
- Lead Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 132
- Able and willing to provide a written informed consent；
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Has a life expectancy≥ 12 weeks；
- At least one measurable lesion according to RECIST v1.1；
- Pathologically confirmed advanced solid tumor；
- Adequate bone marrow reserve and organ function.
- Have received anti-PD-1 or PD-L1 antibody therapy;
- Subjects with other malignant tumors in the past 3 years;
- Have uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites;
- Previous or current interstitial pneumonia/interstitial lung disease ;
- History of autoimmune disease with the possibility of recurrence or active autoimmune disease;
- Severe infection within 1 month before the first study drug administration;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description phase II cohort 4: SHR-1802+Adebrelimab SHR-1802 - phase Ib：SHR-1802+Adebrelimab Adebrelimab - phase Ib：SHR-1802+Adebrelimab SHR-1802 - phase II cohort 1: SHR-1802+Adebrelimab Adebrelimab - phase II cohort 1: SHR-1802+Adebrelimab SHR-1802 - phase II cohort 2: SHR-1802+Adebrelimab + Platinum Doublet Chemotherapy (PDCT) Adebrelimab - phase II cohort 2: SHR-1802+Adebrelimab + Platinum Doublet Chemotherapy (PDCT) SHR-1802 - phase II cohort 2: SHR-1802+Adebrelimab + Platinum Doublet Chemotherapy (PDCT) Carboplatin/Cisplatin - phase II cohort 2: SHR-1802+Adebrelimab + Platinum Doublet Chemotherapy (PDCT) Paclitaxel/Nab-Paclitaxel/Pemetrexed - phase II cohort 3: SHR-1802+Adebrelimab + PDCT Adebrelimab - phase II cohort 3: SHR-1802+Adebrelimab + PDCT SHR-1802 - phase II cohort 3: SHR-1802+Adebrelimab + PDCT Carboplatin/Cisplatin - phase II cohort 3: SHR-1802+Adebrelimab + PDCT Paclitaxel/Nab-Paclitaxel/Pemetrexed - phase II cohort 4: SHR-1802+Adebrelimab Adebrelimab -
- Primary Outcome Measures
Name Time Method Dose limiting toxicity (DLT) 3 weeks ORR up to 2 years Objective Response Rate, determined according to RECIST v1.1 criteria
Recommended phase II dose (RP2D) up to 2 months
- Secondary Outcome Measures
Name Time Method DCR up to 2 years Disease Control Rate, determined according to RECIST v1.1 criteria
12-month OS rate from the date of the first dose up to 2 years OS (overall survival) up to 2 years From date of treatment start to any cause death or last follow-up
TTR up to 2 years Time to Response，determined according to RECIST v1.1 criteria
DOR up to 2 years Duration of Response, determined according to RECIST v1.1 criteria
PFS assessed by investigator up to 2 years Progression Free Survival, determined according to RECIST v1.1 criteria
Trial Locations
- Locations (1)
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China