NCT06386146 · Jacobio Pharmaceuticals Co., Ltd.
JAB-30355 in Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation
What this study is about
This study is to evaluate the effectiveness and safety of JAB-30355 in adult participants with advanced solid tumors harboring TP53 Y220C mutation.
View original scientific description
This study is to evaluate the efficacy and safety of JAB-30355 in adult participants with advanced solid tumors harboring TP53 Y220C mutation.
Interventions
DRUG
JAB-30355
Oral administration
DRUG
JAB-30355
Oral administration
Primary outcome measures
Dose limiting toxicity (DLT)
Time frame: Approximately one year
Number and proportion of participants who experience at least one dose limiting toxicity (DLT)
Number of participants with adverse events
Time frame: Approximately 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Denver, Colorado
- Lake Mary, Florida
- St Louis, Missouri
- Canton, Ohio
- Cleveland, Ohio
- Nashville, Tennessee
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 22, 2026 · Source of record for eligibility and locations