A Study of SHR-1802 in Combination With Adebrelimab in Patients With Advanced Solid Tumors
NCT ID: NCT05794477
Last Updated: 2023-06-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
132 participants
INTERVENTIONAL
2023-04-28
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
Efficacy-expansion: After determination of the recommended dose for Phase II (RP2D), selected cohorts with different tumor types will be expanded.
TREATMENT
NONE
Study Groups
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phase Ib：SHR-1802+Adebrelimab
Adebrelimab
Specified dose on specified days
SHR-1802
Specified dose on specified days
phase II cohort 1: SHR-1802+Adebrelimab
Adebrelimab
Specified dose on specified days
SHR-1802
Specified dose on specified days
phase II cohort 2: SHR-1802+Adebrelimab + Platinum Doublet Chemotherapy (PDCT)
Adebrelimab
Specified dose on specified days
SHR-1802
Specified dose on specified days
Carboplatin/Cisplatin
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
Paclitaxel/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.
phase II cohort 3: SHR-1802+Adebrelimab + PDCT
Adebrelimab
Specified dose on specified days
SHR-1802
Specified dose on specified days
Carboplatin/Cisplatin
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
Paclitaxel/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.
phase II cohort 4: SHR-1802+Adebrelimab
Adebrelimab
Specified dose on specified days
SHR-1802
Specified dose on specified days
Interventions
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Adebrelimab
Specified dose on specified days
SHR-1802
Specified dose on specified days
Carboplatin/Cisplatin
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
Paclitaxel/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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Hengrui Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Hunan Cancer Hospital
Changsha, Hunan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SHR-1802-II-202
Identifier Type: -
Identifier Source: org_study_id
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