Clinical trial NCT05794477: A Study of SHR-1802 in Combination With Adebrelimab in Patients With Advanced Solid Tumors
Official title: An Open Label, Multicenter, Phase Ib/II Study of SHR-1802 in Combination With Adebrelimab in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumor
Lead sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-04-03
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
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

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.


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.

Primary outcomes:
measure: Dose limiting toxicity (DLT)
timeFrame: 3 weeks
measure: Recommended phase II dose (RP2D)
timeFrame: up to 2 months
measure: ORR
timeFrame: up to 2 years
Secondary outcomes:
measure: DOR
timeFrame: up to 2 years
measure: DCR
timeFrame: up to 2 years
measure: PFS assessed by investigator
timeFrame: up to 2 years
measure: TTR
timeFrame: up to 2 years
measure: OS (overall survival)
timeFrame: up to 2 years
measure: 12-month OS rate
timeFrame: from the date of the first dose up to 2 years
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
Study officials:
References: