Clinical trial · Interventional
Arsenic Trioxide for Structural p53 Mutations
Targeting Structural p53 Mutations With Arsenic Trioxide for Intractable Cancer
- 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)
TP53 is the most frequently mutated gene in cancer, but these mutations remain therapeutically non-actionable. Previous study reported arsenic trioxide could rescue structural p53 mutations, endowing p53 mutations with thermostability and transcriptional activity. Under Vivo and Vitro experiments, arsenic trioxide could reactivate mutated p53 to inhibit tumor. This trial aimed to explore the efficacy and safety of arsenic trioxide in refractory cancer patients with structural p53 mutations.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Arsenic Trioxide | — | UNRESOLVED | — |
| Intractable Cancer | — | UNRESOLVED | — |
| p53 Mutations | — | UNRESOLVED | — |
| Refractory Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Arsenic Trioxide | Drug | Arsenic Trioxide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arsenic Trioxide
- description
- Arsenic Trioxide (0.16mg/kg,d1-5,ivgtt,28days as a duration) for injection
- interventionNames
- Drug: Arsenic Trioxide
Primary outcomes (2)
- measure
- Objective Response Rate
- timeFrame
- Evaluation of tumor burden based on RECIST criteria through study completion, an average of 2 months
- description
- Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission
- measure
- Progress Free Survival
- timeFrame
- Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 2 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Malignant solid tumors diagnosed histologically; * Solid tumor patients have no any standard choice after multiple line of therapy; * Next-generation Sequence showed TP53 mutation; * Expected survival ≥ 1 month; * ECOG / PS score: 0-2, and the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL \<1.5 times the upper limit of normal (ULN); Liver ALT and AST \<2.5 × ULN and if liver metastases, ALT and AST \<5 × ULN; Serum Cr ≤ 1 × ULN, endogenous creatinine clearance ≥50ml/min * normal cardiac function * obtain informed consent Exclusion Criteria: * Patient still has standard treatment therapy based on NCCN guidance; * Patient can not comply with research program requirements or follow-up; * woman who are pregnant or breastfeeding; * allergic to any drug in protocol or with contraindications; * cannot understand or obey the protocol; * with a history of allergies or intolerability; * participate in other clinical trials meanwhile; * any situations that hinder trial existed;
References
Publications (1)
- DERIVEDTang Y, Song H, Wang Z, Xiao S, Xiang X, Zhan H, Wu L, Wu J, Xing Y, Tan Y, Liang Y, Yan N, Li Y, Li J, Wu J, Zheng D, Jia Y, Chen Z, Li Y, Zhang Q, Zhang J, Zeng H, Tao W, Liu F, Wu Y, Lu M. Repurposing antiparasitic antimonials to noncovalently rescue temperature-sensitive p53 mutations. Cell Rep. 2022 Apr 12;39(2):110622. doi: 10.1016/j.celrep.2022.110622. PMID 35417717