A Phase 1, Open-Label Study of ABSK112 to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Non-Small Cell Lung Cancer
This is a first-in-human (FIH), multicenter, non-randomized, openlabel, phase 1 study of ABSK112 in patients with NSCLC to evaluate the safety, tolerability, PK, and preliminary antitumor efficacy.
• Patients should understand, sign, and date the written informed consent form prior to screening.
• Male or female aged 18 years or older.
• Patients with histologically or cytologically confirmed locally advanced (and not a candidate for definitive therapy) or metastatic NSCLC.
• Cohort-specific inclusion criteria:
∙ For the escalation part (except for the RDE confirmation part), patients have progressed on, rejected, or are intolerant of standard therapy, or for whom no standard therapy exists
‣ For RDE confirmation in the escalation part: same as Cohort 1 in the expansion part
‣ For the expansion part, patients have documented EGFR in-frame exon 20 insertion mutations confirmed by certificated local laboratories; and must also meet all criteria for the cohort in which their entry is proposed.
• Patients must have at least one measurable target lesion according to RECIST v1.1
• ECOG performance status 0 or 1
• 7\. Life expectancy ≥3 months
• Adequate organ function and bone marrow function.
• Electrolyte: magnesium within 0.85 to 1.25 × institutional normal limits, sodium ≥130 mmol/L, potassium within institutional normal limits
⁃ Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 mmHg at screening and no change in antihypertensive medications within 1 week prior to the Cycle1 Day1.
⁃ For patients participating in food effect exploration part:
• Be able to eat a standardized high-fat meal within 30 minutes
∙ Be able to fast for 10 hours.
⁃ Non-surgically sterilized male or female patients of childbearing potential must agree to use highly effective methods of birth control during the study treatment and for approximately 6 months after the last dose of study drug. A condom is also required to be used by vasectomized men to prevent delivery of the drug via seminal fluid.