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Treatment with JAB-30355 for patients with advanced solid tumors and a specific genetic 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

Phase1; Phase2 Interventional Jacobio Pharmaceuticals Co., Ltd. · NCT06386146

This study is testing a new treatment called JAB-30355 to see if it can help adults with advanced solid tumors that have a specific genetic mutation called TP53 Y220C.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment144 (estimated)
Ages18 Years and up
SexAll
SponsorJacobio Pharmaceuticals Co., Ltd. Industry-sponsored
Locations13 sites (Denver, Colorado and 12 other locations)
Trial IDNCT06386146 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of JAB-30355 in adult patients with advanced solid tumors that have the TP53 Y220C mutation. The study is divided into two phases: a Dose Escalation Phase (Phase 1) to assess safety and determine the maximum tolerated dose (MTD), followed by a Dose Expansion Phase (Phase 2a) to further investigate the clinical benefits and tolerability of the treatment at selected dose levels. Participants must have previously received systemic therapy and have measurable lesions as defined by RECIST criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced solid tumors confirmed to have the TP53 Y220C mutation and who have undergone at least one line of systemic therapy.

Not a fit: Patients with active brain or spinal metastases, severe uncontrolled medical conditions, or specific cardiac issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors harboring the TP53 Y220C mutation.

How similar studies have performed: While this approach is focused on a specific mutation, similar studies targeting genetic mutations in solid tumors have shown promising results, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Denver, Colorado and 12 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Solid TumorsTP53 Y220C reactivatorTP53 Y220C mutationP53Tumor protein p53TP53Advanced solid tumorsOvarian Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.