RECRUITING

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

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Conditions

Solid Tumors

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-07-24
Study Completion:2027-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06386146

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Written informed consent.
  2. * Participant must be ≥18 years of age at the time of signing the Informed Consent Form (ICF).
  3. * ECOG performance status score of 0 or 1.
  4. * Has been treated with at least one line of systemic therapy for that tumor type and stage.
  5. * Have documentation of confirmed TP53 Y220C mutation.
  6. * At least 1 measurable lesion per RECIST v1.1.
  7. * Adequate hematological, renal and hepatic function and appropriate coagulation condition.
  8. * Able to swallow and retain orally administered medication.
  1. * Active brain or spinal metastases or primary CNS tumor.
  2. * Active infection requiring systemic treatment within 7 days.
  3. * Active HBV or HCV.
  4. * Any severe and/or uncontrolled medical conditions.
  5. * LVEF ≤50% assessed by ECHO or MUGA.
  6. * QTcF\>470 msec.

Contacts and Locations

Study Contact

Jacobio Pharmaceuticals
CONTACT
781-918-6670
clinicaltrials@jacobiopharma.com

Study Locations (Sites)

Research site
Lake Mary, Florida, 32771
United States
Research site
Rochester, Minnesota, 55906
United States
Research site
Saint Louis, Missouri, 63110
United States
Research site
Canton, Ohio, 44718
United States
Research site
Cleveland, Ohio, 44195
United States
Research site
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Jacobio Pharmaceuticals Co., Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-24
Study Completion Date2027-07

Study Record Updates

Study Start Date2024-07-24
Study Completion Date2027-07

Terms related to this study

Additional Relevant MeSH Terms

  • Solid Tumors