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RecruitingInterventionalPhase 1/Phase 2

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

NCT ID: NCT06386146Sponsor: Jacobio Pharmaceuticals Co., Ltd.Last updated: 2026-05-22

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

Sex: AllAge: 18 Years and olderHealthy 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.

Study locations (7)

Research Site

Denver, Colorado, 80218

Recruiting

Research site

Lake Mary, Florida, 32771

Terminated

Research site

St Louis, Missouri, 63110

Recruiting

Research site

Canton, Ohio, 44718

Terminated

Research site

Cleveland, Ohio, 44195

Recruiting

Research Site

Nashville, Tennessee, 37203

Recruiting

Research site

Houston, Texas, 77030

Recruiting
JAB-30355 in Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation | Cancerify