A Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-21822 Monotherapy and Combination Therapy in Adult Patients with Advanced Solid Tumors Harboring KRAS G12C Mutation - JAB-21822-1001

Jacobio Pharmaceuticals Co. Ltd.0 个研究点目标入组 136 人开始时间: 2024年7月12日最近更新: 2024年7月22日

研究概览

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•Participants must have at least 1 measurable lesion as defined by RECIST v1.1., Participants must be able to provide an archived tumor sample, Participant has histologically or cytologically confirmed solid tumors with KRAS G12C mutation, Must have received at least 1 prior standard therapy, Participants must be able to swallow and retain orally administered medication., Participants must have laboratory data that meet the following criteria: a. Absolute neutrophil count =1.5 × 109/L. b. Platelet count =100 × 109/L. c. Hemoglobin =9 g/dL. d. Albumin =3.0 g/dL. e. Total bilirubin =1.5 × ULN (with Gilbert’s syndrome, =2.0 × ULN). f.AST and ALT =1.5 × ULN (with presence of liver metastases, =3 × ULN). g.PT and PTT <1.5 × ULN and INR <1.5 if the participant is not on anticoagulants, or INR <3 after dose titration has been completed if the participant is on anticoagulants. h.Kidney function is normal with a CrCl = 60 mL/min (measured using Cockcroft-Gault equation; see Appendix 13.4). i.TSH within normal range at baseline. Additional thyroid function testing (such as free T4, T3, etc.) can be performed at the investigator’s discretion.

•Active infection requiring systemic treatment at the start of treatment in this trial. A washout period of 7 days after the last dose of antibiotics, antivirals, or antifungals prior to first dose of study drug is required., Participant has brain or spinal metastases, except if treated by surgery, surgery plus radiotherapy or radiotherapy alone, with no evidence of radiographic progression or hemorrhage for at least 28 days, Has active HBV or HCV, History of any severe and/or uncontrolled medical conditions, LVEF =50% assessed by ECHO or QTcF, QT interval >470 msec, Participants experiencing unresolved Grade >1 toxicity before the start of treatment with the study drug

发起方

Jacobio Pharmaceuticals Co. Ltd.