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Clinical Trials in the USA / NCT06386146
Recruiting Phase 1/2

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

NCT06386146 · tracked via the Priya Life Science USA tracker
Sponsor
Jacobio Pharmaceuticals Co., Ltd
Phase
Phase 1/2
Started
2024-07-24
Last updated
2026-05-22

Condition(s) studied

Solid Tumors

Investigational drug(s) / intervention(s)

JAB-30355JAB-30355

JAB-30355: Oral administration

JAB-30355: Oral administration

Study summary

This study is to evaluate the efficacy and safety of JAB-30355 in adult participants with advanced solid tumors harboring TP53 Y220C mutation.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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.

Primary outcome measure(s)

  • 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.

Trial sites (15)

FacilityCityRegionStatus
Research Site Denver Colorado Recruiting
Research site Lake Mary Florida Terminated
Research site St Louis Missouri Recruiting
Research site Canton Ohio Terminated
Research site Cleveland Ohio Recruiting
Research Site Nashville Tennessee Recruiting
Research site Houston Texas Recruiting
Research Site Beijing Beijing Municipality Recruiting
Research Site Beijing Beijing Municipality Recruiting
Research Site Beijing Beijing Municipality Recruiting
Research Site Guangzhou Guangdong Recruiting
Research Site Zhengzhou Henan Recruiting
Research Site Shenyang Liaoning Recruiting
Research Site Jinan Shandong Recruiting
Research Site Shanghai Shanghai Municipality Recruiting

More Jacobio Pharmaceuticals Co., Ltd. trials in the USA

JAB-2485 Activity in Adult Patients With Advanced Solid Tumors Recruiting
JAB-23E73 in Adult Participants With Advanced Solid Tumors With KRAS Alteration Recruiting

Other trials for the same condition

A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studies Recruiting
Phase 1a/b Study of ZL-6201 Safety, PK, and Preliminary Efficacy in Sarcoma and Selected Tumors Recruiting
A Study of ZL-1310 in Participants With Selected Solid Tumors Recruiting
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Recruiting
Follow-Up for Study Participants Treated With an Allogeneic CAR T Cell Product Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06386146 on ClinicalTrials.gov ↗ ← All trials in the USA