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NCT02175433

A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Escalating Doses of AGS67E Given as Monotherapy in Subjects With Refractory or Relapsed Lymphoid Malignancies

Completed Phase 1 Last updated 1 November 2024
What this trial tests

Phase 1 trial testing AGS67E in Relapsed Lymphoid Malignancy in 71 participants. Completed in 29 October 2019.

Timeline
14 October 2014
Primary endpoint
29 October 2019
29 October 2019

Quick facts

Lead sponsorAstellas Pharma Global Development, Inc.
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingnone
Primary purposetreatment
Enrollment71
Start date14 October 2014
Primary completion29 October 2019
Estimated completion29 October 2019
Sites5 locations across Canada, United States

Drugs / interventions tested

Conditions studied

Sponsor

Astellas Pharma Global Development, Inc. — full company profile →

Who can join

18 and older, any sex, with Relapsed Lymphoid Malignancy or Refractory Lymphoid Malignancy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of AGS67E both without and with myeloid growth factor (GF) in subjects with refractory or relapsed lymphoid malignancies. Immunogenicity and anticancer activity of AGS67E will also be assessed.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Exploration of the antibody-drug conjugate clinical landscape.
    Maecker H, Jonnalagadda V, Bhakta S, Jammalamadaka V, et al · · 2023 · cited 90× · PMID 37639687 · DOI 10.1080/19420862.2023.2229101
  2. Advances in targeted therapy for malignant lymphoma.
    Wang L, Qin W, Huo YJ, Li X, et al · · 2020 · cited 88× · PMID 32296035 · DOI 10.1038/s41392-020-0113-2
  3. Antibody-drug conjugates in clinical trials for lymphoid malignancies and multiple myeloma.
    Yu B, Liu D. · · 2019 · cited 70× · PMID 31500657 · DOI 10.1186/s13045-019-0786-6
  4. Biomaterials from the sea: Future building blocks for biomedical applications.
    Wan MC, Qin W, Lei C, Li QH, et al · · 2021 · cited 69× · PMID 33997505 · DOI 10.1016/j.bioactmat.2021.04.028
  5. CAR-T cell therapy in T-cell malignancies: Is success a low-hanging fruit?
    Safarzadeh Kozani P, Safarzadeh Kozani P, Rahbarizadeh F. · · 2021 · cited 56× · PMID 34620233 · DOI 10.1186/s13287-021-02595-0
  6. Antibody-drug conjugates for the treatment of lymphoma: clinical advances and latest progress.
    Chu Y, Zhou X, Wang X. · · 2021 · cited 48× · PMID 34090506 · DOI 10.1186/s13045-021-01097-z
  7. Current Status of Marine-Derived Compounds as Warheads in Anti-Tumor Drug Candidates.
    Newman DJ, Cragg GM. · · 2017 · cited 43× · PMID 28353637 · DOI 10.3390/md15040099
  8. Monoclonal Antibody Therapies for Hematological Malignancies: Not Just Lineage-Specific Targets.
    Cuesta-Mateos C, Alcaraz-Serna A, Somovilla-Crespo B, Muñoz-Calleja C. · · 2017 · cited 39× · PMID 29387053 · DOI 10.3389/fimmu.2017.01936

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Other trials of AGS67E

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02175433.

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