Last reviewed 2026-05-25 · How we verify

chemotherapy plus p53

chemotherapy plus p53 is a Combination chemotherapy with p53 gene therapy Small molecule drug developed by Shenzhen SiBiono GeneTech Co.,Ltd. It is currently FDA-approved for Head and neck cancer, Lung cancer, Other solid tumors with p53 deficiency.

This combination therapy uses chemotherapy alongside a p53 gene therapy to restore tumor suppressor function and enhance cancer cell death.

Chemotherapy is used to treat various cancers, including ovarian cancer, primary peritoneal cavity cancer, testicular cancer, ovarian epithelial cancer, and fallopian tube cancer. The chemotherapy regimen typically involves a combination of paclitaxel and carboplatin, with or without the small molecule SCH-58500, which targets the p53 protein.

At a glance

Mechanism of action

The p53 component is a gene therapy that delivers functional p53 tumor suppressor protein to cancer cells, restoring apoptosis and cell cycle control mechanisms that are often lost in tumors. When combined with chemotherapy, the restored p53 function can sensitize cancer cells to chemotherapy-induced DNA damage and increase treatment efficacy. This approach targets the fundamental p53 mutation or loss found in many human cancers.

Approved indications

• Head and neck cancer
• Lung cancer
• Other solid tumors with p53 deficiency

Common side effects

• Myelosuppression
• Nausea and vomiting
• Fatigue
• Infection risk
• Local injection site reactions

Key clinical trials

• Tuvusertib in Astrocytoma With ATRX Mutation (PHASE2)
• Efficacy of Tedopi Plus Docetaxel or Tedopi Plus Nivolumab as Second-line Therapy in Metastatic Non-small-cell Lung Cancer Progressing After First-line Chemo-immunotherapy (Combi-TED) (PHASE2)
• PROfiling Based Endometrial Cancer Adjuvant Therapy (NA)
• Testing Nivolumab in Combination With Decitabine and Venetoclax in Patients With Newly Diagnosed TP53 Gene Mutated Acute Myeloid Leukemia (PHASE1)
• p53 Suppressor Activation in Recurrent High Grade Serous Ovarian Cancer, a Phase Ib/II Study of Systemic Carboplatin Combination Chemotherapy With or Without APR-246 (PHASE1, PHASE2)
• p53 Activation in Platinum-Resistant High Grade Serous Ovarian Cancer, a Study of PLD With APR-246 (PHASE2)
• Phase 1 Study of the Dual MDM2/MDMX Inhibitor ALRN-6924 in Pediatric Cancer (PHASE1)
• Senescence and the Early Ageing Phenotype After Chemotherapy for Testicular Cancer: the SEA-CAT Study (NA)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• chemotherapy plus p53 CI brief — competitive landscape report
• chemotherapy plus p53 updates RSS · CI watch RSS
• Shenzhen SiBiono GeneTech Co.,Ltd portfolio CI

Frequently asked questions about chemotherapy plus p53

Related

• Drug class: All Combination chemotherapy with p53 gene therapy drugs
• Target: All drugs targeting p53 tumor suppressor protein
• Manufacturer: Shenzhen SiBiono GeneTech Co.,Ltd — full pipeline
• Therapeutic area: All drugs in Oncology
• Indication: Drugs for Head and neck cancer
• Indication: Drugs for Lung cancer
• Indication: Drugs for Other solid tumors with p53 deficiency

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing