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

Description

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

Conditions

Solid Tumors

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Solid Tumors
Intervention / Treatment

-

Contacts and Locations

Lake Mary

Research site, Lake Mary, Florida, United States, 32771

Rochester

Research site, Rochester, Minnesota, United States, 55906

Saint Louis

Research site, Saint Louis, Missouri, United States, 63110

Canton

Research site, Canton, Ohio, United States, 44718

Cleveland

Research site, Cleveland, Ohio, United States, 44195

Houston

Research site, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Jacobio Pharmaceuticals Co., Ltd.,

Study Record Dates

2027-07