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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
This study is to evaluate the efficacy and safety of JAB-30355 in adult participants with advanced solid tumors harboring TP53 Y220C mutation.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Research Site
Denver, Colorado, United States
Research site
Lake Mary, Florida, United States
Research site
St Louis, Missouri, United States
Research site
Canton, Ohio, United States
Research site
Cleveland, Ohio, United States
Research Site
Nashville, Tennessee, United States
Research site
Houston, Texas, United States
Research Site
Beijing, Beijing Municipality, China
Research Site
Beijing, Beijing Municipality, China
Research Site
Beijing, Beijing Municipality, China
Start Date
July 24, 2024
Primary Completion Date
January 1, 2027
Completion Date
July 1, 2027
Last Updated
January 22, 2026
144
ESTIMATED participants
JAB-30355
DRUG
JAB-30355
DRUG
Lead Sponsor
Jacobio Pharmaceuticals Co., Ltd.
NCT06898450
NCT06658951
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05719558