^
    1d
    SGT-53 in Children With Recurrent or Progressive CNS Malignancies (clinicaltrials.gov)
    P1, N=0, Withdrawn, SynerGene Therapeutics, Inc. | Not yet recruiting --> Withdrawn
    Trial withdrawal
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    Avastin (bevacizumab) • temozolomide • irinotecan • Onivyde (nanoliposomal irinotecan) • SGT-53
    1d
    A Study of SGT-53 in Children With Refractory or Recurrent Solid Tumors (clinicaltrials.gov)
    P1, N=18, Suspended, SynerGene Therapeutics, Inc. | Trial completion date: Dec 2026 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2027
    Trial completion date • Trial primary completion date
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    cyclophosphamide • topotecan • SGT-53
    16d
    Case Report: Integration of intratumoral oncolytic adenovirus with total neoadjuvant therapy in metachronous locally advanced rectal cancer. (PubMed, Front Oncol)
    At the most recent follow-up, there was no evidence of local recurrence or distant metastasis. This case highlights the potential of oncolytic virotherapy to enhance chemotherapy and radiotherapy effects in LARC patients.
    Journal
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation
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    Oncorine (recombinant human adenovirus type 5)
    18d
    A Prospective, Multicenter, Single-Arm Phase II Exploratory Study of Serplulimab Combined With Oncolytic Virus H101, Short-Course Radiotherapy, and XELOX Chemotherapy as Total Neoadjuvant Treatment for Locally Advanced (cT1-3N0M0) Rectal Cancer (clinicaltrials.gov)
    P2, N=20, Not yet recruiting, Chongqing University Cancer Hospital
    New P2 trial
    |
    capecitabine • oxaliplatin • Hetronifly (serplulimab) • Oncorine (recombinant human adenovirus type 5)
    21d
    Oncolytic human adenovirus 5 (H101) modulates cell cycle progression in HPV16-positive tumors. (PubMed, Biochem Biophys Res Commun)
    In vivo experiments further confirmed the significant antitumor effects and the favorable safety profile of H101. These findings suggest that the antitumor effects of H101 are associated with the downregulation of HPV16 E6/E7 and the activation of the p53-p21 pathway, involving both p53-dependent and p53-independent mechanisms.
    Journal
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    CDK1 (Cyclin-dependent kinase 1)
    |
    Oncorine (recombinant human adenovirus type 5)
    1m
    Recombinant human adenovirus type 5 synergizes with anti-PD-L1 antibody to promote anti-hepatocellular carcinoma effects through multilevel remodeling of the immune microenvironment. (PubMed, Front Immunol)
    The combination of H101 and APA exhibited excellent anti-HCC efficacy, which may reshape the TME partially through the IFN-γ/STAT1/PD-L1 axis. These findings provide a promising strategy to overcome resistance to ICIs in HCC treatment.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma)
    |
    Oncorine (recombinant human adenovirus type 5)
    1m
    P53-armed Oncolytic Adenovirus Enhances the Efficacy of PD-1 Blockade in Neuroblastoma by Inducing Immunogenic Cell Death. (PubMed, Anticancer Res)
    OBP-702 is a promising antitumor strategy to promote the antitumor effect of ICIs by inducing ICD against NB tumors.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • HMGB1 (High Mobility Group Box 1)
    |
    PD-L1 expression • MYCN amplification
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    Telomelysin (suratadenoturev) • pfifteloxin (OBP-702)
    3ms
    Turning pancreatic cancer from cold to hot: the promise of a p53-expressing oncolytic adenovirus (OBP-702). (PubMed, Int J Clin Oncol)
    Of these agents, Telomelysin (OBP-301, Suratadenoturev), a telomerase-specific oncolytic adenovirus, demonstrated clinical safety but limited efficacy in refractory tumors. Given its multifaceted antitumor functions and ability to overcome key barriers in pancreatic cancer, OBP-702 represents a highly promising therapeutic candidate. A first-in-human clinical trial evaluating endoscopic ultrasonography-guided intratumoral injection of OBP-702 is currently in preparation, expected to advance clinical translation of this novel virotherapeutic strategy.
    Review • Journal • Tumor mutational burden • IO biomarker • First-in-human
    |
    KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • TMB (Tumor Mutational Burden) • CDKN1A (Cyclin-dependent kinase inhibitor 1A) • E2F1 (E2F transcription factor 1)
    |
    TMB-L
    |
    Telomelysin (suratadenoturev) • pfifteloxin (OBP-702)
    3ms
    Strategically engineering an oncolytic herpes simplex virus to improve systemic delivery. (PubMed, Mol Ther Oncol)
    Despite the recent regulatory approvals of oncolytic viruses such as T-VEC (JS1/34.5-/47-/GM-CSF), Oncorine (H101), and Teserpaturev (G47Δ), the clinical impact of OV remains limited by its reliance on intratumoral administration. Preclinical studies demonstrate that FusOn-SD efficiently reaches tumor sites following systemic administration, exhibiting enhanced immune evasion and oncolytic potency. These findings position FusOn-SD as a promising candidate for advancing OV beyond localized injections, with the potential to transform virotherapy into a viable treatment for metastatic cancer.
    Journal
    |
    CSF2 (Colony stimulating factor 2)
    |
    Imlygic (talimogene laherparepvec) • Delytact (teserpaturev) • Oncorine (recombinant human adenovirus type 5)
    3ms
    H101 Plus TACE for r/m HNSCC (clinicaltrials.gov)
    P2, N=20, Not yet recruiting, West China Hospital
    New P2 trial
    |
    Oncorine (recombinant human adenovirus type 5)
    3ms
    Innovative Drug and Prodrug Candidates in Cancer Treatment Targeting TP53 Mutations: Challenge and Hope. (PubMed, Drug Dev Res)
    Small-molecule correctors, statins, Hsp90 inhibitors, and new drugs like Eprenetapopt and COTI-2 are among the therapeutic options proposed. Challenges such as medication resistance, side effects, and the chemical complexity of p53 pathways are also addressed, emphasizing the importance of ongoing research. This review contributes to our understanding of TP53-targeted cancer medicines, offering hope for more innovative treatments with improved outcomes.
    Review • Journal
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation • TP53 wild-type
    |
    eprenetapopt (APR-246) • COTI-2
    3ms
    Vaccine Therapy and Pembrolizumab in Treating Patients With Solid Tumors That Have Failed Prior Therapy (clinicaltrials.gov)
    P1, N=11, Active, not recruiting, City of Hope Medical Center | Trial completion date: Oct 2025 --> Oct 2026
    Trial completion date
    |
    TP53 (Tumor protein P53) • MSI (Microsatellite instability)
    |
    TP53 mutation
    |
    Keytruda (pembrolizumab) • p53MVA