133P Phase I/II study of XTX101: A masked, tumor-activated Fc-enhanced anti-CTLA-4, in patients with advanced solid tumors Article Swipe
Diwakar Davar
,
John George Knecht
,
Andrae Lavon Vandross
,
Cesar A. Perez
,
David M. Miller
,
John D. Powderly
,
Alberto Bessudo
,
K. Montazeri
,
Meghan J. Mooradian
,
Anurag Gupta
,
Eshan U. Patel
,
Damiano Fantini
,
S. Paramasivan
,
D Crowe
,
Meghan Duncan
,
Susan Uptain
,
Katarina Luptakova
,
Ryan J. Sullivan
·
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.1016/j.iotech.2023.100605
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.1016/j.iotech.2023.100605
XTX101 is a tumor-activated, Fc-enhanced, high affinity anti-CTLA-4 monoclonal antibody designed with masking peptides that block the CTLA-4 antigen-binding regions. The masking peptides, covalently linked, are cleaved by proteases upregulated in the tumor microenvironment compared to healthy tissues. XTX101 contains 2 mutations that facilitate Fcγ receptor binding and improve effector function. XTX101-01/02-001 (NCT04896697) Part 1A examined XTX101 in 3+3 dose escalation in patients (pts) with advanced solid tumors. Part 1B examined pharmacodynamic (PD) biomarkers. As of August 3, 2023, 27 pts were evaluable for safety, median age 67, median 4 prior lines of therapy (1-12). In Part 1A, 5 dose levels (DL) were evaluated. Among 6 pts treated at 60 mg every 3 weeks (Q3W), 1 dose limiting toxicity (DLT) of colitis was seen. Among 6 pts treated at 180 mg Q3W, 2 DLTs of colitis were seen. At 150 mg every 6 weeks (Q6W) there were no DLTs and this was chosen as the recommended regimen[CF1] . There were no grade (G) 4/5 treatment-related adverse events (TRAEs), and no endocrine or liver-related TRAEs on the study. Among 18 pts treated with XTX101 at Q3W schedule (DL 7-180 mg), G3 TRAEs were colitis (n = 4), infusion reaction (n = 3), lymphopenia/lymph count decreased (n = 2), and diarrhea (n = 1). In 9 pts treated at 150 mg Q6W, the only G3 TRAEs were diarrhea and dermatitis (1 each). XTX101 exposure at 150 mg Q6W was comparable to 2 cycles of 60 mg Q3W. One pt, at 150 mg Q6W, with PD-L1 negative non-small cell lung cancer had a confirmed partial response (PR) ongoing at 36 weeks, with resolution of hepatic metastases and only TRAE of G1 fatigue. Supporting tumor-selective activity of XTX101, this pt had minimal changes in peripheral PD markers. Data from tumor biopsies from 2 other pts showed >70% activated molecule in tumor vs 13% in plasma. XTX101, an Fc-enhanced, tumor-activated, anti-CTLA-4, has a differentiated safety profile from systemically active anti-CTLA4 and showed evidence of monotherapy clinical activity with a confirmed PR. Part 1B is ongoing at 150 mg Q6W. Development of XTX101 is planned in combination with atezolizumab for pts with microsatellite stable colorectal cancer.
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- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1016/j.iotech.2023.100605
- http://www.esmoiotech.org/article/S259001882300268X/pdf
- OA Status
- gold
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4389480884
All OpenAlex metadata
Raw OpenAlex JSON
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https://openalex.org/W4389480884Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.1016/j.iotech.2023.100605Digital Object Identifier
- Title
-
133P Phase I/II study of XTX101: A masked, tumor-activated Fc-enhanced anti-CTLA-4, in patients with advanced solid tumorsWork title
- Type
-
articleOpenAlex work type
- Language
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enPrimary language
- Publication year
-
2023Year of publication
- Publication date
-
2023-12-01Full publication date if available
- Authors
-
Diwakar Davar, John George Knecht, Andrae Lavon Vandross, Cesar A. Perez, David M. Miller, John D. Powderly, Alberto Bessudo, K. Montazeri, Meghan J. Mooradian, Anurag Gupta, Eshan U. Patel, Damiano Fantini, S. Paramasivan, D Crowe, Meghan Duncan, Susan Uptain, Katarina Luptakova, Ryan J. SullivanList of authors in order
- Landing page
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https://doi.org/10.1016/j.iotech.2023.100605Publisher landing page
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https://www.esmoiotech.org/article/S259001882300268X/pdfDirect link to full text PDF
- Open access
-
YesWhether a free full text is available
- OA status
-
goldOpen access status per OpenAlex
- OA URL
-
https://www.esmoiotech.org/article/S259001882300268X/pdfDirect OA link when available
- Concepts
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Medicine, Internal medicine, Gastroenterology, RegimenTop concepts (fields/topics) attached by OpenAlex
- Cited by
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0Total citation count in OpenAlex
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10Other works algorithmically related by OpenAlex
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