- Active, not recruiting
NCT03215030: Phase 1/2: Safety, Tolerability, Efficacy, Pharmacok. Immunogenicity of TAK-573 in RRMM
Updated: Feb 10
Modakafusp alfa (Formerly TAK-573)
NCT03215030: Phase 1/2: A Study to Investigate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of TAK-573 in Participants With Refractory Multiple Myeloma (MM)
A Study to Investigate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of TAK-573 in Participants With Refractory Multiple Myeloma (MM)
The main aims of this 3-part study are as follows:
Part 1: To determine any side effects from modakafusp alfa single treatment and how often they occur. The dose of modakafusp alfa will be increased a little at a time until the highest dose that does not cause harmful side effects is found.
Part 2: To assess clinical activity of one or more dosing schedules of modakafusp alfa alone in participants with relapsed/refractory multiple myeloma. Dexamethasone standard dose will be administered with one or more selected dose of modakafusp alfa in selected group of participants.
Part 3: To find the optimal dose with the more favorable risk-benefit profile of modakafusp alfa.
Participants will receive modakafusp alfa at one of two doses which will be given through a vein.
Sponsor:
ClinicalTrials.gov Identifier: NCT03215030
Official Title: A Phase 1/2 Open-label Study to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of TAK-573 as a Single Agent in Patients With Refractory Multiple Myeloma
First Posted : July 12, 2017
Click here to see details on ClinicalTrials.gov
Drug: TAK-573
Drug: Dexamethasone
Modakafusp Alfa (Code C140427)
Anti-CD38-targeted IgG4-attenuated IFNa TAK-573
Anti-CD38-targeted IgG4-attenuated Interferon Alpha TAK-573
CD38-targeted IgG4 Fused with Attenuated IFNa
Modakafusp Alfa
MODAKAFUSP ALFA
TAK-573
TEV-48573
EHA2022 Oral Presentation
EHA 2022 - HYBRID - JUNE 9-17 - VIENNA
MODAKAFUSP ALFA (TAK-573): UPDATED CLINICAL, PHARMACOKINETIC (PK), AND IMMUNOGENICITY RESULTS FROM A PHASE 1/2 STUDY IN PATIENTS (PTS) WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA (RRMM)
COMY 22 - Session 15: Abstract communications
PDATE FROM A FIRST-IN-HUMAN PHASE 1 STUDY OF MODAKAFUSP ALFA (TAK-573), A FIRST-INCLASS IMMUNOCYTOKINE, IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA
(RRMM)
Intenational Myeloma Foundation: Updated Results on Modakafusp Alfa (TAK-573) Safety and Efficacy; Phase 1/2 Study of RRMM Patients
Jun 23, 2022
898 Modakafusp Alfa (TAK-573), an Immunocytokine, Shows Clinical Activity in Patients with Relapsed/Refractory Multiple Myeloma; Updated Results from a First-in-Human Phase 1 Study
Program: Oral and Poster Abstracts
Type: Oral
Session: 653. Myeloma and Plasma Cell Dyscrasias: Clinical-Prospective Therapeutic Trials: Immune Therapy for Multiple Myeloma
Hematology Disease Topics & Pathways:
Clinical Trials, Biological, Adults, Clinical Research, Plasma Cell Disorders, Diseases, Therapies, Immunotherapy, Lymphoid Malignancies, Study Population
Monday, December 13, 2021: 7:00 PM
Intenational Myeloma Foundation: Modakafusp Alfa (TAK-573), an Immunocytokine, in Pts with Relapsed/Refractory Multiple Myeloma
Dec 14, 2021
Locations
United States, Georgia
United States, Massachusetts
United States, Nebraska
United States, New Jersey
United States, North Carolina
United States, Ohio
United States, Pennsylvania