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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Research Site
  Denver, Colorado, United States Recruiting
• Research site
  St Louis, Missouri, United States Recruiting
• Research site
  Cleveland, Ohio, United States Recruiting
• Research Site
  Nashville, Tennessee, United States Recruiting
• Research site
  Houston, Texas, United States Recruiting
• Research Site
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Jacobio Pharmaceuticals
• Email: clinicaltrials@jacobiopharma.com
• Phone: 781-918-6670

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.