JAB-30355 in Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation
- Registration Number
- NCT06386146
- Lead Sponsor
- Jacobio Pharmaceuticals Co., Ltd.
- Brief Summary
This study is to evaluate the efficacy and safety of JAB-30355 in adult participants with advanced solid tumors harboring TP53 Y220C mutation.
- Detailed Description
This study consists of two parts: Dose Escalation Phase (Phase 1) and Dose Expansion Phase (Phase 2a). The primary objective of dose escalation is to evaluate the safety and tolerability, and to determine the MTD of JAB-30355 monotherapy administered in participants with advanced solid tumors harboring TP53 Y220C mutation. Dose expansion will further explore JAB-30355's clinical benefit and tolerability in selected dose levels.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 144
- Written informed consent.
- Participant must be β₯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.
- 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 β€50% assessed by ECHO or MUGA.
- QTcF>470 msec.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose escalation phase JAB-30355 Multiple dose levels of JAB-30355 will be explored to determine the maximum tolerated dose (MTD) Dose expansion phase JAB-30355 Dose Expansion Phase will explore JAB-30355's clinical benefit and optimal tolerability in selected dose level.
- Primary Outcome Measures
Name Time Method Number of participants with adverse events Approximately three years All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms et al.
Dose limiting toxicity (DLT) Approximately one year Number and proportion of participants who experience at least one dose limiting toxicity (DLT)
- Secondary Outcome Measures
Name Time Method Terminal half-life (t1/2) Approximately three years Terminal half-life of JAB-30355 in human. Plasma concentrations of JAB-30355 from subjects will be used to calculate PK parameters.
Duration of response (DOR) Approximately three years DOR is defined as the time from the date of the first documented response (CR or PR) to the earliest date of disease progression or death, whichever occurs first, as determined by investigator assessment per RECIST v1.1.
Time to reach the observed maximum (peak) concentration (Tmax) Approximately three years Time to reach the observed maximum (peak) concentration. Plasma concentrations of JAB-30355 from subjects will be used to calculate PK parameters.
Peak Plasma Concentration (Cmax) Approximately three years Observed maximum plasma concentration after administration. Plasma concentrations of JAB-30355 from subjects will be used to calculate PK parameters.
Objective response rate (ORR) Approximately three years ORR is defined as the percentage of participants with partial response (PR) or complete response (CR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Trial Locations
- Locations (2)
Research Site
π¨π³Shanghai, Shanghai, China
Research site
πΊπΈHouston, Texas, United States