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

Sponsor: Jacobio Pharmaceuticals Co., Ltd.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06386146

Patient View

This clinical trial evaluates the safety, tolerability, and efficacy of JAB-30355 in adults with advanced solid tumors and TP53 Y220C mutation. It includes a Phase 1 dose escalation to determine MTD and a Phase 2a dose expansion. Eligible participants must be ≥18, have an ECOG score of 0-1, prior systemic therapy, confirmed mutation, measurable lesions, and adequate organ function. JAB-30355 is administered orally.

Patient Parameters

Program Overview

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

Description

This study consists of two parts: Dose Escalation Phase (Phase 1) and Dose Expansion Phase (Phase 2a). The primary objective of dose escalation is to evaluate the safety and tolerability, and to determine the MTD of JAB-30355 monotherapy administered in participants with advanced solid tumors harboring TP53 Y220C mutation. Dose expansion will further explore JAB-30355's clinical benefit and tolerability in selected dose levels.

Eligibility 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.

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