A Phase 1/2a, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-30355 in Adult Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation
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.
Arms & interventions
- DrugJAB-30355
Oral administration
- DrugJAB-30355
Oral administration
Outcome measures
Primary
Dose limiting toxicity (DLT)
Number and proportion of participants who experience at least one dose limiting toxicity (DLT)
Time frame: Approximately one year
Number of participants with adverse events
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.
Time frame: Approximately three years
Secondary
Peak Plasma Concentration (Cmax)
Time frame: Approximately three years
Time to reach the observed maximum (peak) concentration (Tmax)
Time frame: Approximately three years
Terminal half-life (t1/2)
Time frame: Approximately three years
Objective response rate (ORR)
Time frame: Approximately three years
Duration of response (DOR)
Time frame: Approximately three years
Eligibility criteria
Study locations (7)
Research Site
Denver, Colorado, 80218
Research site
Lake Mary, Florida, 32771
Research site
St Louis, Missouri, 63110
Research site
Canton, Ohio, 44718
Research site
Cleveland, Ohio, 44195
Research Site
Nashville, Tennessee, 37203
Research site
Houston, Texas, 77030