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JAB-30355 in Patients 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

Who can join

Ages 18 and older · All sexes

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.

About the study

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

What is being tested

• JAB-30355 (drug)
• JAB-30355 (drug)

Sponsor: Jacobio Pharmaceuticals Co., Ltd. · Participants: 144 · Started: Jul 24, 2024

Contact the study team

• Jacobio Pharmaceuticals · Phone: 781-918-6670

Official record on ClinicalTrials.gov — NCT06386146

Locations in the U.S.

Conditions

• Ovarian Cancer

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.