Clinical trial · Interventional
JAB-30355 in Patients With Advanced Solid Tumors Harboring TP53 Y220C 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
NCT06386146CI-TRIAL-00112382recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is to evaluate the efficacy and safety of JAB-30355 in adult participants with advanced solid tumors harboring TP53 Y220C mutation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JAB-30355 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose escalation phase
- description
- Multiple dose levels of JAB-30355 will be explored to determine the maximum tolerated dose (MTD)
- interventionNames
- Drug: JAB-30355
- type
- EXPERIMENTAL
- label
- Dose expansion phase
- description
- Dose Expansion Phase will explore JAB-30355's clinical benefit and optimal tolerability in selected dose level.
- interventionNames
- Drug: JAB-30355
Primary outcomes (2)
- measure
- Dose limiting toxicity (DLT)
- timeFrame
- Approximately one year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.