ArticleClinical cancer research : an official journal of the American Association for Cancer Research2022
First-In-Human Phase I Study of the OX40 Agonist MOXR0916 in Patients with Advanced Solid Tumors.
Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 43 papers.
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The trial behind it
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Who cites it
43 citing papers in PubMed, 79 citations in OpenAlex.
- First-in-human phase I/II, open-label study of mRNA-2416 alone or combined with durvalumab in patients with advanced solid tumors and ovarian cancer.The oncologist · 2025Trial
- Trial
- OX40 (TNFRSF4) Tracks Immune Infiltration in Small Cell Lung Cancer and Shows a Cohort-Specific, Non-Replicated Association with the POU2F3/SCLC-P Subtype: A Multi-Source In Silico Analysis.International journal of molecular sciences · 2026Article
- Efficient discovery of an agonistic anti-OX40 nanobody by epitope-directed approach to address enrichment-driven epitope bias.Journal for immunotherapy of cancer · 2026Article
- HFB301001, an OX40-based immunotherapy, drives Treg clearance and CTL activation through optimized OX40 receptor clustering.Journal for immunotherapy of cancer · 2026Article
- Precision immuno-oncology in oral cancer: latest trends in biomarkers, novel drug development and nanoparticle-based therapeutic platforms.Frontiers in cell and developmental biology · 2026Review
- OX40 signaling in cancer immunotherapy: mechanisms of action, translational applications, and therapeutic perspectives.Frontiers in immunology · 2026Review
- Harnessing multivalency and FcγRIIB engagement to augment anti-CD27 immunotherapy.Nature communications · 2025Article
- A phase I study of the OX40 agonist BGB-A445 with or without tislelizumab, an anti-PD-1 monoclonal antibody, in patients with advanced solid tumors: dose-escalation results.Cancer chemotherapy and pharmacology · 2025Article
- Review
- Anti-OX40 antibody BAT6026 in patients with advanced solid tumors: A multi-center phase I study.iScience · 2025Article
- Multi-omics analysis of tumor necrosis factor superfamily 4 reveals its prognostic value with T cell exhaustion feature in cancer.Discover oncology · 2025Article
- INBRX-106: a hexavalent OX40 agonist that drives superior antitumor responses via optimized receptor clustering.Journal for immunotherapy of cancer · 2025Article
- First-in-human, phase 1 dose escalation study of SL-279252, a hexameric PD1-Fc-OX40L fusion protein, in patients with advanced solid tumors and lymphoma.Investigational new drugs · 2025Article
- A Phase I Clinical Trial Adding OX40 Agonism to In Situ Therapeutic Cancer Vaccination in Patients with Low-Grade B-cell Lymphoma Highlights Challenges in Translation from Mouse to Human Studies.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025Article
- Targeting novel regulated cell death: disulfidptosis in cancer immunotherapy with immune checkpoint inhibitors.Biomarker research · 2025Review
- Harnessing the tumor microenvironment: targeted cancer therapies through modulation of epithelial-mesenchymal transition.Journal of hematology & oncology · 2025Review
- Generation of novel human anti-OX-40 mAbs endowed with different biological properties as tools for cancer therapy.Frontiers in immunology · 2025Article
- OX40/OX40L: a new target for tumor immunotherapy and its clinical research progress.Frontiers in oncology · 2025Review
- SHR-1806, a robust OX40 agonist to promote T cell-mediated antitumor immunity.Cancer biology & therapy · 2024Article
Corrections and comments
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Authors and funding
25 authors at 18 institutions in 6 countries.
Funding
Abstract
purposeOX40, a receptor transiently expressed by T cells upon antigen recognition, is associated with costimulation of effector T cells and impairment of regulatory T-cell function. This first-in-human study evaluated MOXR0916, a humanized effector-competent agonist IgG1 monoclonal anti-OX40 antibody. PATIENTS AND
methodsEligible patients with locally advanced or metastatic refractory solid tumors were treated with MOXR0916 intravenously once every 3 weeks (Q3W). A 3+3 dose-escalation stage (0.2-1,200 mg; n = 34) was followed by expansion cohorts at 300 mg (n = 138) for patients with melanoma, renal cell carcinoma, non-small cell lung carcinoma, urothelial carcinoma, and triple-negative breast cancer.
resultsMOXR0916 was well tolerated with no dose-limiting toxicities observed. An MTD was not reached. Most patients (95%) experienced at least one adverse event (AE); 56% of AEs, mostly grade 1-2, were related to MOXR0916. Most common treatment-related AEs included fatigue (17%), diarrhea (8%), myalgia (7%), nausea (6%), decreased appetite (6%), and infusion-related reaction (5%). Pharmacokinetic (PK) parameters were dose proportional between 80 and 1,200 mg and supported Q3W administration. The recommended expansion dose based on PK and OX40 receptor saturation was 300 mg Q3W. Immune activation and upregulation of PD-L1 was observed in a subset of paired tumor biopsies. One renal cell carcinoma patient experienced a confirmed partial response. Overall, 33% of patients achieved stable disease.
conclusionsAlthough objective responses were rarely observed with MOXR0916 monotherapy, the favorable safety profile and evidence of tumor immune activation in a subset of patients support further investigation in combination with complementary agents such as PD-1/PD-L1 antagonists.
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