• Recruiting

NCT03399799: Phase 1 - Talquetamab, a Humanized GPRC5D x CD3 Bis Ab - Ref MM - MonumenTAL-1

Updated: Sep 29

MonumenTAL-1 study


A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of Talquetamab, a Humanized GPRC5D x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma

MonumenTAL-1 study

Dose Escalation Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma


The purpose of this study is to characterize the safety of Talquetamab and to determine the recommended Phase 2 dose(s) (RP2Ds) and dosing schedule assessed to be safe for Talquetamab (Part 1 [Dose Escalation]) and to further characterize the safety of Talquetamab at the recommended Phase 2 dose(s) (RP2Ds) (Part 2 [Dose Expansion]). Study record NCT04634552 is Phase 2 part of this study and study record NCT03399799 is Phase 1 part of this study.

 

Sponsor

Janssen Research & Development, LLC


Multiple locations

International Study

 

ClinicalTrials.gov Identifier: NCT03399799

Official Title: A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of Talquetamab, a Humanized GPRC5D x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma

First Posted : January 16, 2018

Click here to see details on ClinicalTrials.gov

 

Talquetamab

Talquetamab (Code C171840)

Anti-CD3/Anti-GPRC5D Bispecific Monoclonal Antibody JNJ-64407564

GPRC5D x CD3 Bispecific Antibody JNJ-64407564

GPRC5D x CD3 DuoBody Antibody JNJ-64407564

GPRC5D/CD3 DuoBody Antibody JNJ-64407564

Humanized GPRC5D x CD3 DuoBody Antibody JNJ-64407564

JNJ 64407564

JNJ-64407564

JNJ64407564

Talquetamab

TALQUETAMAB

 

A T-cell-redirecting bispecific G-protein-coupled receptor class 5 member D x CD3 antibody to treat multiple myeloma

Blood; April 2020

Click here for details

 

290 A Phase 1, First-in-Human Study of Talquetamab, a G Protein-Coupled Receptor Family C Group 5 Member D (GPRC5D) x CD3 Bispecific Antibody, in Patients with Relapsed and/or Refractory Multiple Myeloma (RRMM)Clinically Relevant Abstract

Program: Oral and Poster Abstracts

Type: Oral

Session: 653. Myeloma/Amyloidosis: Therapy, excluding Transplantation: Bispecific T Cell Engager Therapies and Novel Targeting Agents

Hematology Disease Topics & Pathways:

multiple myeloma, Diseases, Plasma Cell Disorders, Lymphoid Malignancies

Saturday, December 5, 2020: 2:00 PM


Learn more

 

RARITAN, N.J., November 4, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that more than 45 company-sponsored abstracts, including 11 oral presentations, plus more than 35 investigator-initiated studies will be featured at the American Society of Hematology (ASH) Annual Meeting and Exposition. ASH is taking place at the Georgia World Congress Center in Atlanta and virtually from December 11-14, 2021.


Updated results from the Phase 1 MonumenTAL-1 (Abstract #158) study, evaluating talquetamab (GPRC5DxCD3) – an investigational, off-the-shelf, T-cell redirecting bispecific antibody and the first directed at this novel target for heavily pre-treated patients with multiple myeloma – will be featured in an oral presentation.


Click here for details

 

158 Updated Phase 1 Results from MonumenTAL-1: First-in-Human Study of Talquetamab, a G Protein-Coupled Receptor Family C Group 5 Member D x CD3 Bispecific Antibody, in Patients with Relapsed/Refractory Multiple Myeloma

Program: Oral and Poster Abstracts

Type: Oral

Session: 653. Myeloma and Plasma Cell Dyscrasias: Clinical-Prospective Therapeutic Trials: Novel Targets and Amyloid

Hematology Disease Topics & Pathways:

Clinical Trials, Biological, Bispecific Antibody Therapy, Clinical Research, Plasma Cell Disorders, Diseases, Therapies, Immunotherapy, Lymphoid Malignancies

Saturday, December 11, 2021: 12:15 PM


Learn more

 

EHA2022 Oral Presentation

EHA 2022 - HYBRID - JUNE 9-17 - VIENNA

TALQUETAMAB, A G PROTEIN-COUPLED RECEPTOR FAMILY C GROUP 5 MEMBER D X CD3 BISPECIFIC ANTIBODY, IN RELAPSED/REFRACTORY MULTIPLE MYELOMA: UPDATED EFFICACY AND SAFETY RESULTS FROM MONUMENTAL-1


Click here to see Abstract details

 

- Alabama: University of Alabama at Birmingham

- California: City of Hope Duarte

- Colorado: University of Colorado Cancer Center Aurora

- New York: Tisch Cancer Institute Mount Sinai Hospital New York

- Tennessee: Sarah Cannon Research Institute Nashville

 

Locations

United States, Alabama

United States, California

United States, Colorado

United States, New York

United States, Tennessee


Europe

Netherlands

Spain

Belgium

 

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