This study is a multicenter, open label, dose exploration/efficacy extension Phase I clinical trial aimed at evaluating the safety, tolerability, pharmacokinetics and efficacy of SHR-1049 injection in patients with advanced solid tumors.
Voluntarily join this study, sign the informed consent form, have good compliance, and can cooperate with follow-up;
Age range of 18-75 years old (including 18 and 75 years old, calculated on the day of signing informed consent), both male and female are eligible;
Dose exploration stage: Participants with advanced or metastatic solid tumors diagnosed by tissue or cytological pathology who have failed standard treatment (disease progression or toxicity intolerance) or have no effective standard treatment;
Stage of efficacy extension: Late stage or metastatic solid tumors diagnosed by tissue or cytological pathology;
Accompanied by untreated or active central nervous system (CNS) tumor metastasis; Participants with a history of meningeal metastasis or current meningeal metastasis;
Imaging shows tumor invasion of large blood vessels or unclear boundary with blood vessels; Or it may be determined by researchers that the participant's tumor has a high possibility of invading important blood vessels and causing fatal massive bleeding during treatment;
Previous or concurrent presence of other malignant tumors;
Chest effusion, pericardial effusion, or abdominal effusion that is accompanied by clinical symptoms, difficult to control, or moderate or above; If fluid drainage is performed (excluding diagnostic puncture surgery), those who have been stable for at least 2 weeks after drainage can be included in the group;
Parallel
SHR-1049 Injection
DrugSHR-1049 injection.
6
Treatment groupsSee each treatment group below.
The incidence and severity of dose-limiting toxicity (DLT).
The first dosing cycle after each subject's enrollment is the DLT observation period.
Adverse events (AEs).
Continuous observation from each participant's knowledge until the end of the safety follow-up period.
Serious adverse events (SAEs).
Continuous observation from each participant's knowledge until the end of the safety follow-up period.
Maximum tolerated dose (MTD).
Based on the preliminary data summary evaluation, it is estimated that after completing the dose group ramping up and expanding the efficacy of 1-2 cohorts into the group with preliminary efficacy results, corresponding results can be obtained.
Pharmacokinetics (PK) indicator - Blood drug concentration.
The plan is to conduct an evaluation within 4 weeks after each dose escalation and within 4 weeks after each dose expansion. The PK evaluation of efficacy expansion needs to be evaluated based on specific preliminary data as appropriate.
Immunogenic indicator - Anti-drug antibody (ADA) levels.
The plan is to conduct an evaluation within 4 weeks after each dose escalation and within 4 weeks after each dose expansion. The ADA evaluation of efficacy expansion needs to be evaluated based on specific preliminary data as appropriate.
Effectiveness indicator - Researchers evaluated objective response rate (ORR).
After the first medication, imaging examinations should be conducted every 6 weeks (±7 days) for the first 36 weeks and every 9 weeks (±7 days) thereafter, and follow-up should be continued until the subject's imaging progress.
Effectiveness indicator - Researchers evaluated duration of response (DoR).
After the first medication, imaging examinations should be conducted every 6 weeks (±7 days) for the first 36 weeks and every 9 weeks (±7 days) thereafter, and follow-up should be continued until the subject's imaging progress.
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