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NCT06386146PHASE1, PHASE2Recruiting

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

Jacobio Pharmaceuticals Co., Ltd.

Start Date

7/24/2024

Completion Date

7/1/2027

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

JAB-30355

DRUG

JAB-30355

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Conditions

Solid Tumors

Locations

Research Site

Denver, Colorado 80218

United States

Research site

Lake Mary, Florida 32771

United States

Research site

St Louis, Missouri 63110

United States

Research site

Canton, Ohio 44718

United States

Research site

Cleveland, Ohio 44195

United States

Research Site

Nashville, Tennessee 37203

United States

Research site

Houston, Texas 77030

United States

Research Site

Beijing, Beijing Municipality 100000

China

Research Site

Beijing, Beijing Municipality 100021

China

Research Site

Beijing, Beijing Municipality 100142

China

Research Site

Guangzhou, Guangdong 510000

China

Research Site

Zhengzhou, Henan 451191

China

Research Site

Shenyang, Liaoning 110801

China

Research Site

Jinan, Shandong 250117

China

Research Site

Shanghai, Shanghai Municipality 200032

China