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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
Phase 1 trial testing AGS67E in Relapsed Lymphoid Malignancy in 71 participants. Completed in 29 October 2019.
29 October 2019
Quick facts
| Lead sponsor | Astellas Pharma Global Development, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 71 |
| Start date | 14 October 2014 |
| Primary completion | 29 October 2019 |
| Estimated completion | 29 October 2019 |
| Sites | 5 locations across Canada, United States |
Drugs / interventions tested
- AGS67E — full drug profile →
Conditions studied
- Relapsed Lymphoid Malignancy — all drugs for Relapsed Lymphoid Malignancy →
- Refractory Lymphoid Malignancy — all drugs for Refractory Lymphoid Malignancy →
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):
-
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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
Verify or expand the search:
- PubMed search for NCT02175433
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of AGS67E
Trials testing the same drug.
- NCT02610062 — A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Escalating Doses of AGS67E Given as Monotherapy in Sub · Phase 1 · terminated
Other Astellas Pharma Global Development, Inc. trials
Trials by the same sponsor.
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- NCT07409272 — A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherap · Phase 3 · recruiting
- NCT07287995 — A Study of ASP2998 Given by Itself and Given With Standard Therapies in People With Solid Tumors · Phase 1, PHASE2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02175433 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Astellas Pharma Global Development, Inc.
- Last refreshed: 1 November 2024
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing