ArticleClinical cancer research : an official journal of the American Association for Cancer Research2021
GEN-1 in Combination with Neoadjuvant Chemotherapy for Patients with Advanced Epithelial Ovarian Cancer: A Phase I Dose-escalation Study.
Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
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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
16 citing papers in PubMed, 24 citations in OpenAlex.
- The evolution of nanomedicine: The rise of next-generation nanomaterials in cancer nanomedicine.Science advances · 2025Review
- Nanocarriers for cutting-edge cancer immunotherapies.Journal of translational medicine · 2025Review
- Immune microenvironment features underlying the superior efficacy of neoadjuvant immunochemotherapy over chemotherapy in local advanced gastric cancer.Frontiers in immunology · 2025Article
- Cancer immunotherapy and its facilitation by nanomedicine.Biomarker research · 2024Review
- Beyond Lipids: Exploring Advances in Polymeric Gene Delivery in the Lipid Nanoparticles Era.Advanced materials (Deerfield Beach, Fla.) · 2024Review
- Redox-Responsive Polymeric Nanoparticle for Nucleic Acid Delivery and Cancer Therapy: Progress, Opportunities, and Challenges.Macromolecular bioscience · 2024Review
- Transforming ovarian cancer care by targeting minimal residual disease.Med (New York, N.Y.) · 2023Article
- Clinical and translational advances in ovarian cancer therapy.Nature cancer · 2023Review
- Engineering Rapalog-Inducible Genetic Switches Based on Split-T7 Polymerase to Regulate Oncolytic Virus-Driven Production of Tumour-Localized IL-12 for Anti-Cancer Immunotherapy.Pharmaceuticals (Basel, Switzerland) · 2023Article
- Targeting tumor-associated macrophages for successful immunotherapy of ovarian carcinoma.Journal for immunotherapy of cancer · 2023Review
- Immunotherapy with IL12 and PD1/CTLA4 inhibition is effective in advanced ovarian cancer and associates with reversal of myeloid cell-induced immunosuppression.Oncoimmunology · 2023Article
- Combat Against Gynecological Cancers with Blood Vessels as Entry Point: Anti-Angiogenic Drugs, Clinical Trials and Pre-Clinical Nano-Delivery Platforms.International journal of nanomedicine · 2023Review
- Emerging strategies in targeting tumor-resident myeloid cells for cancer immunotherapy.Journal of hematology & oncology · 2022Review
- Development of Delivery Systems for Local Administration of Cytokines/Cytokine Gene-Directed Therapeutics: Modern Oncologic Implications.Current oncology reports · 2022Review
- Tumor microenvironment features decipher the outperformance of neoadjuvant immunochemotherapy over chemotherapy in resectable non-small cell lung cancer.Frontiers in immunology · 2022Article
- Bibliometric analysis of hotspots and frontiers in cancer-related fatigue among ovarian cancer survivors.PloS one · 2022Article
Corrections and comments
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Authors and funding
11 authors at 7 institutions in 1 country.
Funding
Abstract
purposeGEN-1 (phIL-12-005/PPC), an IL12 plasmid formulated with polyethyleneglycol-polyethyleneimine cholesterol lipopolymer, has preclinical activity when combined with platinum-taxane intravenous chemotherapy and administered intraperitoneally in epithelial ovarian cancer (EOC) models. OVATION I was a multicenter, nonrandomized, open-label phase IB trial to evaluate the safety, preliminary antitumor activity, and immunologic response to GEN-1 in combination with neoadjuvant chemotherapy (NACT) carboplatin-paclitaxel in patients with advanced EOC. PATIENTS AND
methodsA total of 18 patients with newly diagnosed stage IIIC and IV EOC were enrolled. A standard 3+3 dose-escalation design tested four GEN-1 doses (36, 47, 61, 79 mg/m
resultsThe most common treatment-emergent adverse events at least possibly related were nausea, fatigue, abdominal pain/cramping, anorexia, diarrhea, and vomiting. Eight patients experience grade 4 neutropenia attributed to NACT. No DLTs occurred. A total of 14 patients were evaluable for response and 12 (85.7%) had radiological response (two complete response and 10 partial response) prior to debulking; nine were R0 at debulking and one patient had complete pathologic response. IL12 and its downstream cytokine, IFNγ, increased in peritoneal washings but not as much in blood. Increased levels of myeloid dendritic cells and T-effector memory cells in peritoneal fluid, plus elevated CD8
conclusionsAdding GEN-1 to standard NACT is safe, appears active, and has an impact on the tumor microenvironment.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.