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Phase I, First-in-Human Study of the Probody Therapeutic CX-2029 in Adults with Advanced Solid Tumor Malignancies
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Abstract
Purpose: PROCLAIM-CX-2029 is a phase I first-in-human study of CX-2029, a Probody–drug conjugate targeting CD71 (transferrin receptor 1) in adults with advanced solid tumors. Although the transferrin receptor is highly expressed across multiple tumor types, it has not been considered a target for antibody–drug conjugates (ADCs) due to its broad expression on normal cells. CX-2029 is a masked form of a proprietary anti-CD71 antibody conjugated to monomethyl auristatin E, designed to be unmasked in the tumor microenvironment by tumor-associated proteases, therefore limiting off-tumor toxicity and creating a therapeutic window for this previously undruggable target. Patients and Methods: This was a dose-escalation, multicenter trial to evaluate the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of CX-2029. The primary endpoint was to determine the maximum tolerated dose (MTD) and cycle 1 dose-limiting toxicity (DLT). CX-2029 was administered i.v. every 3 weeks. Results: Forty-five patients were enrolled in eight dose levels. No DLTs were reported in the dose escalation through 4 mg/kg. At 5 mg/kg, there were two DLTs (febrile neutropenia and pancytopenia). Following expansion of the 4 mg/kg dose to six patients, two additional DLTs were observed (infusion-related reaction and neutropenia/anemia). Both the 4 and 5 mg/kg doses were declared above the maximum tolerated dose. The recommended phase II dose is 3 mg/kg. The most common dose-dependent hematologic toxicities were anemia and neutropenia. Confirmed partial responses were observed in three patients, all with squamous histologies. Conclusions: The Probody therapeutic platform enables targeting CD71, a previously undruggable ADC target, at tolerable doses associated with clinical activity. See related commentary by Oberoi and Garralda, p. 4459
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In 2021, Johnson's group disclosed a phase I (NCT02222922) first-in-human study involving CX-2029 to evaluate its therapeutic effects on adults with solid tumors.
“In 2021, Johnson’s group disclosed a phase I (NCT02222922) first-in-human study involving a CX-2029 to evaluate its therapeutic effects on adults with solid tumors.651”
From Recent advances in targeting the “undruggable” proteins: from drug discovery to clinical trials (2023) · cites this paper as [651]
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Metadata
- Authors
- Johnson, M., El-Khoueiry, A., Hafez, N., Lakhani, N., Mamdani, H., Rodon, J., Sanborn, R. E., Garcia-Corbacho, J., Boni, V., Stroh, M., Hannah, A. L., Wang, S., Castro, H., & Spira, A.
- Affiliations
- Sarah Cannon (US)
- University of Southern California (US)
- Yale Cancer Center (US)
- South Texas Accelerated Research Therapeutics (US)
- The Barbara Ann Karmanos Cancer Institute (US)
- The University of Texas MD Anderson Cancer Center (US)
- Providence Portland Medical Center (US)
- 8Department of Medical Oncology (Hospital Clinic Barcelona)/Translational Genomics and Targeted Therapies in Solid Tumors (IDIBAPS), Barcelona, Spain.
- Hospital Universitario HM Sanchinarro (ES)
- CytomX Therapeutics (United States) (US)
- Virginia Cancer Specialists (US)
- Corresponding author
- Johnson, Melissa
- ORCID
- Venue
- Clinical Cancer Research
- Published
- 2021-06-03
- Volume
- 27
- Issue
- 16
- Pages
- 4521-4530
- ISSN
- 1078-0432 (ISSN-L)
- 1557-3265
- OpenAlex
- W3164185366
- Cited by
- 72
- References
- 20
- Citations by year
- 2026: 18 · 2025: 7 · 2024: 16 · 2023: 14 · 2022: 15 · 2021: 2
- FWCI
- 6.19
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Clinical Cancer Research (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Immunology and Microbiology › Immunology › Monoclonal and Polyclonal Antibodies Research
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Physical Sciences › Materials Science › Biomaterials › Nanoparticle-Based Drug Delivery
- Keywords
- antibody-drug conjugates, transferrin receptor, transferrin receptor 1, monomethyl auristatin E, advanced solid tumors, maximum tolerated dose, dose-limiting toxicity, tumor-associated proteases, on-target off-tumor toxicity, hematologic toxicity, anticancer activity
- MeSH terms
- Adult, Aged, Female, Humans, Male, Middle Aged, Neoplasm Staging, Neoplasms, Prodrugs, Immunoconjugates, Antibodies, Monoclonal, Humanized
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