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. 2022 Sep 6;11(9):1325. doi: 10.3390/biology11091325

Table 2.

Examples of clinical studies exploring p53-oriented therapies in solid tumors.

Study ID Phase Drug Mechanism of Action
NCT02429726 II Recombinant adenoviral human p53 Replacement of defective p53.
NCT00004038 I
NCT00004041 I
NCT00003588 I
NCT00003167 I
NCT02429037 II
NCT00004225 I
NCT00894153 IV
NCT00902122 IV
NCT00902083 IV
NCT02435186 II
NCT01574729 II
NCT03544723 II
NCT02842125 I/II
NCT00776295 II
NCT02340117 II SGT-53 (cationic liposome encapsulating p53)
NCT02340156 II
NCT01639885 II Vaccine from tp53-derived peptides Immune-mediated elimination of p53 mutated neoplastic clones.
NCT00001827 II
NCT00844506 II
NCT02577588 I Adoptive transfer of ex vivo reactivated p53 specific T cells
NCT03113487 II Modified vaccinia virus Ankara vaccine expressing p53
NCT02432963 I
NCT01191684 I
NCT02275039 I
NCT00019916 I/II Autologous peripheral blood-derived antigen-presenting cells pulsed in vitro with p53-derived
NCT00978913 I
NCT00019929 II
NCT00617409 II
NCT00082641 I/II Autologous dendritic cells pulsed with adenovirus p53
NCT01042535 I/II
NCT00393029 II TP53/T-cell receptor transduced peripheral blood lymphocytes
NCT00496860 I/II ALT-801 Induction of immune response against p53+ cells. The drug is a bifunctional fusion protein comprising interleukin-2 linked to a soluble, single-chain T-cell receptor domain that recognizes a peptide epitope (aa264–272) of the human p53 antigen displayed on cancer cells in the context of HLA-A*0201 (p53+/HLA-A*0201).
NCT01029873 I/II
NCT01760525 I CGM097 MDM2 inhibition.
NCT05180695 I/II HDM201
NCT02143635 I/II
NCT03781986 I/II APG-115
NCT03611868 I/II
NCT03975387 I/II ASTX295
NCT03217266 I Navtemadlin
NCT02264613 I/II ALRN-6924
NCT04585750 I/II PC14586 Small molecule “reactivating” p53. It binds to the crevice of mutant p.Y220C p53, restoring the normal structure and tumor suppressing function.
NCT01975116 I Azurin-derived cell-penetrating peptide p28 After preferentially penetrating cancer cells, azurin induces a post-translational increase in p53 by inhibiting its ubiquitination.
NCT02098343 I/II APR-246 It binds to cysteine residues in mutant p53, thereby producing thermo dynamic stabilization of the protein and shifting equilibrium toward a functional conformation.
NCT03268382 I

Only therapeutic studies were selected. Diagnostic, prognostic or early detection studies were not included. Clinical trials whose status was “unknown” or “withdrawn” or “suspended” were not included into this table (reporting only active or completed trials).