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JAB-30355 for Advanced Solid Tumors with TP53 Y220C Mutation

This study is testing a new oral medication called JAB-30355 for adults with advanced solid tumors that have a specific genetic change called a TP53 Y220C mutation. To join, you must be at least 18 years old, have an ECOG performance status of 0 or 1 (meaning you are fully active or can carry out light work), and have already received at least one prior treatment for your cancer. The main goals are to find a safe dose of JAB-30355 and to see how well it works. The study is planned to include 144 participants, but its current recruitment status is unclear.

Study design
This study is an interventional study with two parts: a dose escalation phase and a dose expansion phase. It plans to enroll 144 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for dose-limiting toxicity for approximately one year, and for adverse events for approximately three years.

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NCT06386146

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Jacobio Pharmaceuticals Co., Ltd.
~144 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:JAB-30355

At a glance

Recruiting sites
13 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose limiting toxicity (DLT)
Measured over Approximately one year
+1 more outcome measured

Conditions

Solid Tumors

Explore related trials

Malignant Ovarian NeoplasmSolid NeoplasmTP53 Gene

Where it's being run

15 sites across 12 states
Beijing Municipality3
Ohio2
Colorado1
Florida1
Missouri1
Tennessee1
Texas1
Guangdong1

Who to contact

Jacobio Pharmaceuticals
[email protected]
781-918-6670
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • 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 eventsApproximately 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.