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Trial Title:
A Study of SHR-1802 in Combination With Adebrelimab in Patients With Advanced Solid Tumors
NCT ID:
NCT05794477
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Paclitaxel
Carboplatin
Pemetrexed
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
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.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Adebrelimab
Description:
Specified dose on specified days
Arm group label:
phase II cohort 1: SHR-1802+Adebrelimab
Arm group label:
phase II cohort 2: SHR-1802+Adebrelimab + Platinum Doublet Chemotherapy (PDCT)
Arm group label:
phase II cohort 3: SHR-1802+Adebrelimab + PDCT
Arm group label:
phase II cohort 4: SHR-1802+Adebrelimab
Arm group label:
phase Ib：SHR-1802+Adebrelimab
Intervention type:
Biological
Intervention name:
SHR-1802
Description:
Specified dose on specified days
Arm group label:
phase II cohort 1: SHR-1802+Adebrelimab
Arm group label:
phase II cohort 2: SHR-1802+Adebrelimab + Platinum Doublet Chemotherapy (PDCT)
Arm group label:
phase II cohort 3: SHR-1802+Adebrelimab + PDCT
Arm group label:
phase II cohort 4: SHR-1802+Adebrelimab
Arm group label:
phase Ib：SHR-1802+Adebrelimab
Intervention type:
Drug
Intervention name:
Carboplatin/Cisplatin
Description:
Specified dose on specified days. Participant will receive only two of the listed
chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with
immunotherapy.
Arm group label:
phase II cohort 2: SHR-1802+Adebrelimab + Platinum Doublet Chemotherapy (PDCT)
Arm group label:
phase II cohort 3: SHR-1802+Adebrelimab + PDCT
Intervention type:
Drug
Intervention name:
Paclitaxel/Nab-Paclitaxel/Pemetrexed
Description:
Specified dose on specified days. Participant will receive only two of the listed
chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with
immunotherapy.
Arm group label:
phase II cohort 2: SHR-1802+Adebrelimab + Platinum Doublet Chemotherapy (PDCT)
Arm group label:
phase II cohort 3: SHR-1802+Adebrelimab + PDCT
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410013
Country:
China
Status:
Recruiting
Contact:
Last name:
Hui Wang, Doctor
Phone:
+86-13973135460
Email:
wanghui@hnca.org.cn
Start date:
April 28, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Shanghai Hengrui Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Shanghai Hengrui Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05794477
