A written informed consent should be signed by a subject or his/her legal representative before any study-related procedures are performed;
Subjects with histologically or cytologically confirmed locally advanced or metastatic advanced solid tumors harboring KRAS p.G12C mutation who have failed or lack standard-of-care (SOC) or are unwilling to undergo or intolerant to SOC;
Expected survival ≥ 3 months;
Subjects must have at least one measurable lesion as defined by RECIST v1.1. If no measurable lesion untreated with radiation is selected as the target lesion, a lesion treated with radiation ≥ 4 weeks before the first dose and with progression confirmed by radiography may be selected as the target lesion;
Eastern Cooperative Oncology Group(ECOG) performance status 0-1;
The organ functions of subjects meet the criteria for the following laboratory parameters at screening;
Subjects must be able to swallow oral medications without gastrointestinal abnormalities that significantly affect drug absorption
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Patients with previous (≤ 3 years) or current tumors of other pathological types, except for cured cervical carcinoma in situ, ductal carcinoma in situ of the breast, prostatic intraepithelial neoplasia, superficial non-invasive bladder cancer, stage I skin cancer (except melanoma); subjects without recurrence or metastasis for \> 3 years after treatment, without current evidence of tumor, and without significant risk of recurrence of previous malignant diseases in the opinion of the study doctor may also be enrolled;
Serious allergy to the investigational drug or excipients (such as microcrystalline cellulose, etc.);
Patients with previous (≤ 6 months before the initiation of treatment) or current severe autoimmune diseases (including adverse reactions caused by previous anti- tumor immunotherapies), or autoimmune diseases requiring long-term systemic hormone therapy at immunosuppressive dose levels (prednisone \> 10 mg/day or equivalent drugs);
HIV, hepatitis B virus(HBV), or hepatitis C virus(HCV) positive;
Previous (≤ 6 months prior to the first dose) or current evidence of the following diseases: acute myocardial infarction, unstable angina and cerebrovascular accident;
Subjects who have impaired cardiac functions or clinically significant cardiac diseases;
Pregnant or lactating women
Clareo Health | Phase 1/2a Study of JAB-21822 Plus JAB-3312 in Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation
