A Study of SHR-1802 in Combination With Adebrelimab in Patients With Advanced Solid Tumors

Hengrui Medicine

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: Carboplatin/Cisplatin; Drug: Paclitaxel/Nab-Paclitaxel/Pemetrexed; Biological: Adebrelimab; Biological: SHR-1802

Study type: Interventional

Funder types: Industry

Identifiers

NCT05794477

SHR-1802-II-202

Details and patient eligibility

About

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.

Enrollment: 132 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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132 participants in 5 patient groups

phase Ib：SHR-1802+Adebrelimab

Experimental group

Treatment:

Biological: Adebrelimab

Biological: SHR-1802

phase II cohort 1: SHR-1802+Adebrelimab

Experimental group

Treatment:

Biological: Adebrelimab

Biological: SHR-1802

phase II cohort 2: SHR-1802+Adebrelimab + Platinum Doublet Chemotherapy (PDCT)

Experimental group

Treatment:

Drug: Paclitaxel/Nab-Paclitaxel/Pemetrexed

Drug: Carboplatin/Cisplatin

Biological: Adebrelimab

Biological: SHR-1802

phase II cohort 3: SHR-1802+Adebrelimab + PDCT

Experimental group

Treatment:

Drug: Paclitaxel/Nab-Paclitaxel/Pemetrexed

Drug: Carboplatin/Cisplatin

Biological: Adebrelimab

Biological: SHR-1802

phase II cohort 4: SHR-1802+Adebrelimab

Experimental group

Treatment:

Biological: Adebrelimab

Biological: SHR-1802