A phase I dose-escalation study to a predefined dose of a transforming growth factor-β1 monoclonal antibody (TβM1) in patients with metastatic cancer
Open accessAbstract
Transforming growth factor β (TGF-β) plays an important role in cancer. Monoclonal antibodies (mAb) designed to specifically block the TGF-β ligands, are expected to inhibit tumor progression in patients with metastatic cancer. TβM1 is a humanized mAb optimized for neutralizing activity against TGF-β1. The objective of this clinical trial was to assess the safety and tolerability of TβM1 in patients with metastatic cancer. In this phase I, uncontrolled, non-randomized, dose-escalation study, 18 eligible adult patients who had measurable disease per RECIST and a performance status of ≤ 2 on the ECOG scale were administered TβM1 intravenously over 10 min at doses of 20, 60, 120 and 240 mg on day 1 of each 28-day cycle. Safety was assessed by adverse events (as defined by CTCAE version 3.0) and possible relationship to study drug, dose-limiting toxicities and laboratory changes. Systemic drug exposure and pharmacodynamic (PD) parameters were assessed. TβM1 was safe when administered once monthly. The pharmacokinetic (PK) profile was consistent with a mAb with a mean elimination half-life approximately 9 days. Although anticipated changes in PD markers such as serum VEGF, bFGF and mRNA expression of SMAD7 were observed in whole-blood, suggesting activity of TβM1 on the targeted pathway, these changes were not consistent to represent a PD effect. Additionally, despite the presence of an activated TGF-β1 expression signature in patients' whole blood, the short dosing duration did not translate into significant antitumor effect in the small number of patients investigated in this study.
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IMC-TRI (LY3022859) was not further pursued due to onset of uncontrolled cytokine release syndrome at higher doses before therapeutic benefit was observed.
“but was not further pursued due to onset of uncontrolled cytokine release syndrome at higher doses before therapeutic benefit was observed305 (Table 1).”
From TGFβ biology in cancer progression and immunotherapy (2021) · cites this paper as [305]
Escalating doses of a TβRII antibody (LY3022859, Eli Lilly) in patients with advanced carcinomas resulted in effects indicative of a cytokine release syndrome, prior to reaching a dose that was considered efficacious for cancer treatment.
“However, escalating doses of a TβRII antibody (LY3022859, Eli Lilly) in patients with advanced carcinomas resulted in effects indicative of a cytokine release syndrome, prior to reaching a dose that was considered efficacious for cancer treatment305.”
From TGFβ biology in cancer progression and immunotherapy (2021) · cites this paper as [305]
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- Authors
- COHN, A., LAHN, M. M., WILLIAMS, K. E., CLEVERLY, A. L., PITOU, C., KADAM, S. K., FARMEN, M. W., DESAIAH, D., RAJU, R., CONKLING, P., & RICHARDS, D.
- Affiliations
- Rocky Mountain Cancer Centers (US)
- Eli Lilly (United States) (US)
- Eli Lilly (United Kingdom) (GB)
- Kettering Medical Center (US)
- Virginia Oncology Associates (US)
- Corresponding author
- LAHN, MICHAEL M.
- Venue
- International Journal of Oncology
- Publisher
- Spandidos Publications
- Published
- 2014-09-26
- Volume
- 45
- Issue
- 6
- Pages
- 2221-2231
- ISSN
- 1019-6439 (ISSN-L)
- 1791-2423
- PMC
- PMC4215585
- OpenAlex
- W2086602355
- Cited by
- 43
- References
- 44
- Citations by year
- 2026: 3 · 2025: 1 · 2024: 7 · 2023: 1 · 2022: 5 · 2021: 7 · 2020: 5 · 2019: 1 · 2018: 3 · 2017: 5 · 2016: 2 · 2015: 1 · 2014: 2
- FWCI
- 1.37
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by-nc
- Locations
- International Journal of Oncology (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Funders
- Eli Lilly and Company
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › TGF-β signaling in diseases
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Monoclonal and Polyclonal Antibodies Research
- Life Sciences › Immunology and Microbiology › Immunology › Biosimilars and Bioanalytical Methods
- Keywords
- TGF-β1, TGF-beta, monoclonal antibodies, metastatic cancer, dose escalation, safety and tolerability, pharmacokinetics, pharmacodynamics, vascular endothelial growth factor, basic fibroblast growth factor, Smad7, humanized monoclonal antibody, anticancer activity
- MeSH terms
- Adenocarcinoma, Adult, Aged, Aged, 80 and over, Animals, Dose-Response Relationship, Drug, Drug Administration Schedule, Humans, Middle Aged, Neoplasm Metastasis, Neoplasm Proteins, Neoplasms, Gene Expression Regulation, Neoplastic, Mice, Transforming Growth Factor beta1, Antibodies, Monoclonal, Humanized, Drug-Related Side Effects and Adverse Reactions
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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