ArticleClinical cancer research : an official journal of the American Association for Cancer Research2011
Phase I trial of ALT-801, an interleukin-2/T-cell receptor fusion protein targeting p53 (aa264-272)/HLA-A*0201 complex, in patients with advanced malignancies.
Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 1 of them a synthesis that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
27 citing papers in PubMed, 1 synthesis or guideline pooled it, 52 citations in OpenAlex.
- A systematic review of interleukin-2-based immunotherapies in clinical trials for cancer and autoimmune diseases.EBioMedicine · 2023Pooled it
- Revisiting tumor immunogenicity through the lens of mutant p53: Implications for cancer immunotherapy.Apoptosis : an international journal on programmed cell death · 2026Review
- Narrative Review of Potential Non-Surgical Treatments for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer.Journal of clinical medicine · 2026Review
- Cytokine Couture: Designer IL2 Molecules for the Treatment of Disease.ImmunoTargets and therapy · 2025Review
- Strategies to therapeutically modulate cytokine action.Nature reviews. Drug discovery · 2023Review
- Natural killer cells in clinical development as non-engineered, engineered, and combination therapies.Journal of hematology & oncology · 2022Review
- Implications and Emerging Therapeutic Avenues of Inflammatory Response in HPV+ Head and Neck Squamous Cell Carcinoma.Cancers · 2022Review
- Review
- Current developments of targeting the p53 signaling pathway for cancer treatment.Pharmacology & therapeutics · 2021Review
- Promising New Tools for Targeting p53 Mutant Cancers: Humoral and Cell-Based Immunotherapies.Frontiers in immunology · 2021Review
- The Impact of a New Interleukin-2-Based Immunotherapy Candidate on Urothelial Cells to Support Use for Intravesical Drug Delivery.Life (Basel, Switzerland) · 2020Article
- Targeting cancers through TCR-peptide/MHC interactions.Journal of hematology & oncology · 2019Review
- Immunopeptidomic Profiling of HLA-A2-Positive Triple Negative Breast Cancer Identifies Potential Immunotherapy Target Antigens.Proteomics · 2018Article
- Next-generation sequencing in non-muscle-invasive bladder cancer-a step towards personalized medicine for a superficial bladder tumor.Translational andrology and urology · 2017Article
- Immunotherapy in urothelial cancer, part 2: adjuvant, neoadjuvant, and adjunctive treatment.Clinical advances in hematology & oncology : H&O · 2017Review
- Review
- Review
- Fusion cytokine IL-2-GMCSF enhances anticancer immune responses through promoting cell-cell interactions.Journal of translational medicine · 2016Article
- Molecular targets in urothelial cancer: detection, treatment, and animal models of bladder cancer.Drug design, development and therapy · 2016Review
- Management of carcinoma in situ of the bladder: best practice and recent developments.Therapeutic advances in urology · 2015Review
Corrections and comments
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Authors and funding
11 authors at 4 institutions in 1 country.
Funding
Abstract
purposeALT-801 is a bifunctional fusion protein comprising interleukin-2 (IL-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). We evaluated the safety, pharmacokinetics, and pharmacodynamics of ALT-801 in p53+/HLA-A*0201 patients with metastatic malignancies. EXPERIMENTAL
designp53+/HLA-A*0201 patients were treated with ALT-801 on a schedule of four daily 15-minute intravenous infusions, then 10 days rest and four more daily infusions. Cohorts of patients were treated at 0.015, 0.040, and 0.080 mg/kg/dose.
resultsFour, 16, and 6 patients were treated at the 0.015, 0.04, and 0.08 mg/kg cohorts, respectively. Two dose-limiting toxicities (a grade 4 transient thrombocytopenia and a myocardial infarction) in the 0.08 mg/kg cohort established the maximum tolerated dose (MTD) at 0.04 mg/kg. Patients treated at the MTD experienced toxicities similar to those associated with high-dose IL-2 but of lesser severity. The serum half-life of ALT-801 was 4 hours and ALT-801 serum recovery was as expected based on the dose administered. ALT-801 treatment induced an increase of serum IFN-γ but not TNF-α. Response assessment showed 10 subjects with stable disease at at least 11 weeks, and in one who had melanoma metastasis, there is an ongoing complete absence of identifiable disease after resection of radiographically identified lesions.
conclusionThis first-in-man study defines an ALT-801 regimen that can be administered safely and is associated with immunologic changes of potential antitumor relevance.
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