Patients with other advanced solid tumors (excluding NSCLC and CRC) who have progressed after prior systemic therapy or are intolerant and lack satisfactory alternative treatment options, aiming to evaluate the efficacy and safety of Glecirasib in these patients.
Patients with the KRAS p.G12C mutation confirmed through testing using prospectively validated companion diagnostic reagents or clinical trial assay (CTA) methods.
Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors (excluding NSCLC and CRC).
Patients with pancreatic cancer must have progressed or been intolerant to prior gemcitabine-based chemotherapy regimens or FOLFIRINOX/mFOLFIRINOX/NALIRIFOX treatment. Patients with other types of solid tumors must have progressed or been intolerant to prior systemic therapies and lack satisfactory alternative treatment options.
Previously received a KRAS G12C inhibitor.
History of interstitial lung disease, non-infectious pneumonia, or uncontrolled lung disease (including pulmonary fibrosis, acute lung disease, etc.) with clinical symptoms.
Uncontrolled pleural effusion, pericardial effusion, or ascites.
Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 electrocardiograms.
Single group
JAB-21822
Drug800mg, orally QD with 21 days each cycle, treatment till disease progression or intolerable toxicity or withdraw for other reasons
Objective response rate (ORR) by independent central radiological review (IRC) according to RECIST 1.1.
ORR is defined as the proportion of participants with confirmed complete response or partial response by IRC according to RECIST 1.1.
Duration of response (DOR)
DOR is defined as the time from date of the first objective tumor response (CR or PR) to the first documentation of either Progression of Disease (PD) or death due to any cause, whichever occurs first.
Time to response (TTR) by IRC according to RECIST 1.1
TTR is defined as the duration of time between the date of the first dose and the date of first documented response of either CR or PR.
Progression-free survival (PFS) by IRC according to RECIST 1.1
PFS is defined as time from the first dose until disease progression or death from any cause, whichever occurs first.
Disease control rate (DCR) by IRC according to RECIST 1.1
DCR is defined as the proportion of participants with BOR of CR or PR or stable disease (SD)
Click on the lead sponsor to view all of their trials.
