JAB-30355 in Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation (NCT06386146) | Clinical Trial Compass
RecruitingPhase 1/2
JAB-30355 in Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation
United States144 participantsStarted 2024-07-24
Plain-language summary
This study is to evaluate the efficacy and safety of JAB-30355 in adult participants with advanced solid tumors harboring TP53 Y220C mutation.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Written informed consent.
* Participant must be ≥18 years of age at the time of signing the Informed Consent Form (ICF).
* ECOG performance status score of 0 or 1.
* Has been treated with at least one line of systemic therapy for that tumor type and stage.
* Have documentation of confirmed TP53 Y220C mutation.
* At least 1 measurable lesion per RECIST v1.1.
* Adequate hematological, renal and hepatic function and appropriate coagulation condition.
* Able to swallow and retain orally administered medication.
Exclusion Criteria:
* Active brain or spinal metastases or primary CNS tumor.
* Active infection requiring systemic treatment within 7 days.
* Active HBV or HCV.
* Any severe and/or uncontrolled medical conditions.
* LVEF ≤50% assessed by ECHO or MUGA.
* QTcF\>470 msec.