Advanced Solid Tumor
Conditions
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.
Interventions
BIOLOGICALAdebrelimab
Specified dose on specified days
BIOLOGICALSHR-1802
Specified dose on specified days
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
DRUGPaclitaxel/Nab-Paclitaxel/Pemetrexed
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
Sponsors
Shanghai Hengrui Pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Dose-exploration：Six patients will be enrolled for tolerability observation. If ≥2 subjects in the previous dose level experienced DLTS, an additional 6 subjects in the other dose level were enrolled. Efficacy-expansion: After determination of the recommended dose for Phase II (RP2D), selected cohorts with different tumor types will be expanded.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose limiting toxicity (DLT) | 3 weeks | — |
| Recommended phase II dose (RP2D) | up to 2 months | — |
| ORR | up to 2 years | Objective Response Rate, determined according to RECIST v1.1 criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| DCR | up to 2 years | Disease Control Rate, 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 |
Countries
China
Contacts
Primary ContactShuni Wang, M.M
Outcome results
None listed