drugset / Trial / NCT04150887
Cusatuzumab in Combination With Background Therapy for the Treatment of Participants With Acute Myeloid Leukemia
Phase 1
Active not recruiting
61 enrolled
OncoVerity, Inc.
Janssen Research & Development, LLC · collabargenx · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of the study is to characterize safety and tolerability of cusatuzumab in combination with various therapies used to treat acute myeloid leukemia (AML).
Timeline
- Start
- 2019-12-23
- Primary completion
- 2027-05-15
- Completion
- 2027-05-15
Publications
- Pabst T, Papayannidis C, Demirkan F, Doronin V, Fogliatto LM, Guttke C, Gyan E, Hamad N, Herrera P, Hultberg A, Jacobs J, Johnson AJ, Langlois A, Ma X, Martinelli G, Arnan M, Muller R, Nottage K, Ofran Y, Ozcan M, Samoilova O, Tolbert JA, Trudel GC, Xiu L, Vey N, Wei AH. Cusatuzumab plus azacitidine in newly diagnosed acute myeloid leukaemia ineligible for intensive chemotherapy (CULMINATE): part one of a randomised, phase 2, dose optimisation study. Lancet Haematol. 2023 Nov;10(11):e902-e912. doi: 10.1016/S2352-3026(23)00207-7.
- Dewulf J, Flieswasser T, Delahaye T, Vangestel C, Miranda A, de Haard H, Jacobs J, Smits E, Van den Wyngaert T, Elvas F. Site-specific 68Ga-labeled nanobody for PET imaging of CD70 expression in preclinical tumor models. EJNMMI Radiopharm Chem. 2023 Apr 24;8(1):8. doi: 10.1186/s41181-023-00194-3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | 75 mg/m2 | Subcutaneous |
| Subject | Cusatuzumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Cusatuzumab | Monoclonal antibody | 20 mg/kg | Intravenous |
| Background | Venetoclax | Small molecule | 400 mg | Oral |