An Open Label, Multicenter, Phase Ib/II Study of SHR-1802 in Combination With Adebrelimab in Patients With Advanced Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- SHR-1802
- Conditions
- Advanced Solid Tumor
- Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Enrollment
- 132
- Locations
- 1
- Primary Endpoint
- Dose limiting toxicity (DLT)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
phase II cohort 3: SHR-1802+Adebrelimab + PDCT
Intervention: SHR-1802
phase II cohort 1: SHR-1802+Adebrelimab
Intervention: SHR-1802
phase Ib：SHR-1802+Adebrelimab
Intervention: Adebrelimab
phase Ib：SHR-1802+Adebrelimab
Intervention: SHR-1802
phase II cohort 1: SHR-1802+Adebrelimab
Intervention: Adebrelimab
phase II cohort 2: SHR-1802+Adebrelimab + Platinum Doublet Chemotherapy (PDCT)
Intervention: Adebrelimab
phase II cohort 2: SHR-1802+Adebrelimab + Platinum Doublet Chemotherapy (PDCT)
Intervention: SHR-1802
phase II cohort 2: SHR-1802+Adebrelimab + Platinum Doublet Chemotherapy (PDCT)
Intervention: Carboplatin/Cisplatin
phase II cohort 2: SHR-1802+Adebrelimab + Platinum Doublet Chemotherapy (PDCT)
Intervention: Paclitaxel/Nab-Paclitaxel/Pemetrexed
phase II cohort 3: SHR-1802+Adebrelimab + PDCT
Intervention: Adebrelimab
phase II cohort 3: SHR-1802+Adebrelimab + PDCT
Intervention: Carboplatin/Cisplatin
phase II cohort 3: SHR-1802+Adebrelimab + PDCT
Intervention: Paclitaxel/Nab-Paclitaxel/Pemetrexed
phase II cohort 4: SHR-1802+Adebrelimab
Intervention: Adebrelimab
phase II cohort 4: SHR-1802+Adebrelimab
Intervention: SHR-1802
Outcomes
Primary Outcomes
Dose limiting toxicity (DLT)
Time Frame: 3 weeks
ORR
Time Frame: up to 2 years
Objective Response Rate, determined according to RECIST v1.1 criteria
Recommended phase II dose (RP2D)
Time Frame: up to 2 months
Secondary Outcomes
- DCR(up to 2 years)
- 12-month OS rate(from the date of the first dose up to 2 years)
- OS (overall survival)(up to 2 years)
- DOR(up to 2 years)
- TTR(up to 2 years)
- PFS assessed by investigator(up to 2 years)