Trial reportCancer research communications2025
First-in-Human Study to Evaluate the Safety and Efficacy of Anti-GDF15 Antibody AZD8853 in Patients with Advanced/Metastatic Solid Tumors.
Trial report in Cancer research communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05397171 (A Phase I/IIa First-in-human, Open-label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AZD8853 in Participants With Selected Advanced/Metastatic Solid Tumours), which is not on this map. Cited by 11 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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.
A Phase I/IIa First-in-human, Open-label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AZD8853 in Participants With Selected Advanced/Metastatic Solid Tumours
Who cites it
11 citing papers in PubMed.
- Trial
- The causes of cachexia: key signals and the brain.Nature reviews. Endocrinology · 2026Review
- GDF15: A Hijacked Metabo-Hormone Orchestrating Cachexia and Immunosuppression in Cancer.Biomolecules · 2026Review
- GDF15 in Liver Fibrosis: Molecular Mechanisms, Immunoregulatory Functions, and Therapeutic Potential.Biomolecules · 2026Review
- Advancing Cancer Cachexia Drug Development: Leveraging Biomarkers and Functional Endpoints to Optimize Trial Design.Cancer reports (Hoboken, N.J.) · 2026Review
- Research progress on the biological function and molecular mechanism of GDF-15 in solid malignant tumors.World journal of surgical oncology · 2026Review
- Hepatic mitochondrial signaling as a systemic hub: inter-organ communication networks in aging and aging-related diseases.Frontiers in cell and developmental biology · 2026Review
- Pleiotropic effects of GDF-15 to regulate nutritional status: perspectives from body composition to nutrition-related disorders.British journal of biomedical science · 2026Review
- Immunomodulatory functions of growth differentiation factor 15 in skin aging and inflammatory dermatoses.Frontiers in immunology · 2026Review
- New Horizons with Growth Differentiation Factor 15 in Oncology: From Cancer Cachexia and Tumour Immunity to Novel Therapeutic Strategies.Current oncology (Toronto, Ont.) · 2025Review
- The Multifaceted Role of Growth Differentiation Factor 15 (GDF15): A Narrative Review from Cancer Cachexia to Target Therapy.Biomedicines · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeGrowth and differentiation factor 15 (GDF15) is overexpressed in multiple solid tumors and is thought to exert immunosuppressive effects in the tumor microenvironment. AZD8853 is an anti-GDF15 mAb. PATIENTS AND
methodsThis first-in-human, phase I/IIa, open-label study (NCT05397171) assessed AZD8853 monotherapy in previously treated patients with advanced/metastatic microsatellite-stable colorectal cancer and urothelial carcinoma. The primary objective was safety including dose-limiting toxicities. Secondary objectives included efficacy, pharmacokinetics, and pharmacodynamics (PD), including free serum GDF15. Exploratory objectives included biomarkers of clinical activity and effects on cancer cachexia.
resultsDuring dose escalation, 16 patients received AZD8853 300 mg (n = 3), 1,000 mg (n = 6), or 3,000 mg (n = 7) intravenously every 3 weeks; 15 patients had microsatellite-stable colorectal cancer; and one patient had urothelial carcinoma. By June 6, 2023, all patients had discontinued treatment. Thirteen (81.3%) patients had treatment-emergent adverse events (TEAE); most commonly diarrhea (31.3%), abdominal pain (31.3%), and decreased appetite (25%). Eight (50.0%) patients had grade ≥3 TEAEs, and six (37.5%) had serious TEAEs, none treatment related. There were no dose-limiting toxicities. The best response per RECIST v1.1 was stable disease in five (31.3%) patients and disease progression in 11 (68.8%) patients. AZD8853 showed linear pharmacokinetics with a half-life of 5 to 10 days, supporting every 3 weeks dosing. AZD8853 suppression of GDF15 was transient. There was no evidence of ctDNA clearance or dose-dependent changes in peripheral T cells. Changes in body weight showed no apparent trends.
conclusionsAZD8853 was well tolerated; however, no objective responses or PD effects were seen, and GDF15 suppression was not sustained. The study was terminated after dose escalation. SIGNIFICANCE: GDF15 is upregulated in the tumor microenvironment and suppresses antitumor immune responses. In this first-in-human trial, the anti-GDF15 antibody AZD8853 was well tolerated in previously treated patients with advanced/metastatic solid tumors, but no objective responses or PD effects were seen and GDF15 suppression was not sustained.
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