• Recruiting

NCT03215030: Phase 1/2: Safety, Tolerability, Efficacy, Pharmacok. Immunogenicity of TAK-573 in RRMM

Updated: Sep 22

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)

TAK 573

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:

Takeda

 

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


TAK-573-1501 | Clinical Trial Summary (takeda.com)

 

Drug: TAK-573

Drug: Dexamethasone

 

TAK-573


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)


Click here for details

 

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)

Click here for details

 

Intenational Myeloma Foundation: Updated Results on Modakafusp Alfa (TAK-573) Safety and Efficacy; Phase 1/2 Study of RRMM Patients

Jun 23, 2022

Click here for details

 

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


Click here for details

 

Intenational Myeloma Foundation: Modakafusp Alfa (TAK-573), an Immunocytokine, in Pts with Relapsed/Refractory Multiple Myeloma

Dec 14, 2021

Click here for details


 

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