Solid Tumors
Conditions
Keywords
TP53 Y220C reactivator; TP53 Y220C mutation; P53; Tumor protein p53; TP53; Advanced solid tumors; Ovarian Cancer; JAB-30355
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.
Interventions
DRUGJAB-30355
Oral administration
Sponsors
Jacobio Pharmaceuticals Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose limiting toxicity (DLT) | Approximately one year | Number and proportion of participants who experience at least one dose limiting toxicity (DLT) |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
China, United States
Contacts
CONTACTJacobio Pharmaceuticals
Outcome results
None listed