NCT03399799: Phase 1 - Talquetamab, a Humanized GPRC5D x CD3 Bis Ab - Ref MM - MonumenTAL-1
Updated: Sep 29, 2022
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
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
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 (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
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
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.
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
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
- 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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