This is a first-in-human (FIH), multicenter, open-label, phase I study of ABSK211 in participants with advanced solid tumors to evaluate safety, tolerability, PK and optimize the dosage.
Inclusion Criteria:
1)be able to eat a standardized high-fat, high caloric meal within 30 minutes. 2) be able to fast for 10 hours.
Exclusion Criteria:
Known allergy or hypersensitivity to any component of the investigational product
Participants who were previously treated with any inhibitors targeting specific KRAS alleles, pan-KRAS inhibitors, pan- or multi-RAS inhibitors, or any other treatments directly targeting RAS.
Has a known additional malignancy that is progressing or has required active treatment
Has swallowing dysfunction or malabsorption syndrome
Previous anti-tumor therapy, including chemotherapy ,endocrine therapy, molecular targeted therapy or other investigational drugs received ≤2 weeks or ≤5-half life ,radiotherapy and antibody therapy received ≤4 weeks prior to initiation of study treatment.
Major surgery within 4 weeks of the first dose of investigational product or with any unhealed surgical wounds, infection or dehiscence.
Prior toxicities from chemotherapy, radiotherapy, and other anti-cancer therapies, including immunotherapy, that have not regressed to Grade ≤1 severity;
Participants use proton pump inhibitors for at least 7 days prior to the first dose of ABSK211 and during treatment with ABSK211.
P-gp inhibitor, moderate and strong CYP3A inhibitors to 7 days or 5 half-lives and for strong CYP3A inducers to 2 weeks or 5 half-lives ;
Active central nervous system (CNS) metastases;
History of interstitial lung disease (ILD) requiring systemic steroid treatment;
Heart disease or medical history ;
NSCLC cohorts: Participant previously identified as having a driver mutation and have not received any targeted therapy;
Known acquired immunodeficiency syndrome (AIDS)-related illness, or positive test for HIV 1/2 antibody;
Exclusion of hepatitis infection;
Participants with refractory/uncontrolled ascites or pleural effusion;
Pregnant or nursing (lactating) women;
Partners of non-surgically sterilized male participants or female participants of childbearing potential who refuse to use effective methods of birth control during the study and for up to 6 months after the last dose of investigational product;
Sexually active males who refuse to use a condom during medication period and until 3 months after stopping investigational product;
Vaccination with a live, attenuated vaccine within 4 weeks prior to the first dose of study treatment except for administration of inactivate vaccines ;
Any other clinically significant comorbidities, such as uncontrolled pulmonary disease, active infection, or any other condition;
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lijun.zheng@abbisko.com+86-021-68912098
During the escalation part ,all participants will firstly receive a single dose of ABSK211 as a run-in period to access the safety and PK of ABSK211. Then, participants will continuously receive ABSK211 once daily (QD), with each treatment cycle of 21 days; In the expansion part,participants will orally receive ABSK211 at the recommended dose for expansion (RDE).
jiaojuan.he@abbisko.com+86-18930059542
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