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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
279
Participants will receive IV infusion or SC injection of Talquetamab.
University of Alabama Birmingham
Birmingham, Alabama, United States
City of Hope
Duarte, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Part 1: Dose-limiting Toxicity (DLT)
The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and defined as any of the following events: hematological / non-hematological toxicity of Grade 3 or higher.
Time frame: Up to Day 28
Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Time frame: From signing of Informed Consent Form (ICF) up to follow up (until 100 days after the last dose of study drug or until the start of subsequent anticancer therapy, if earlier [approximately 2.10 years])
Part 1: Talquetamab Serum Concentrations
Serum concentrations will be calculated for Talquetamab.
Time frame: Up to 4 weeks
Part 1 and Part 2: Biomarker Assessment
Serum cytokine concentrations will be measured pre- and post-infusion of Talquetamab for biomarker assessment.
Time frame: Up to Cycle 7 Day 1 (each cycle of 21-days)
Part 1: Number of Participants with Talquetamab Antibodies
Antibodies to Talquetamab will be assessed to evaluate potential immunogenicity.
Time frame: Up to 4 weeks
Part 2: Overall Response Rate (ORR)
ORR is defined as the proportion of participants who have a partial response (PR) or better according to the international myeloma working group (IMWG) criteria.
Time frame: Approximately 2.10 years
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Mount Sinai Medical Center
New York, New York, United States
Tennessee Oncology
Nashville, Tennessee, United States
Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
Liège, Belgium
VU Medisch Centrum
Amsterdam, Netherlands
UMCU
Utrecht, Netherlands
Hosp. Univ. Germans Trias I Pujol
Badalona, Spain
Hosp Univ Fund Jimenez Diaz
Madrid, Spain
...and 3 more locations
Part 2: Clinical Benefit Rate (CBR)
CBR is defined as the proportion of participants who have a minimal response (MR) or better according to the IMWG criteria.
Time frame: Approximately 2.10 years
Part 2: Duration of Response (DOR)
DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of PD, per IMWG criteria.
Time frame: From the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) (approximately 2.10 years)
Part 2: Time to Response (TTR)
TTR is defined as the time between date of first dose of study drug and the first efficacy evaluation that the participant has met all criteria for PR or better.
Time frame: From the date of first dose of study drug to the date of initial documentation of a response (approximately 2.10 years)
Part 2: Progression-Free Survival (PFS)
PFS is defined as time from date of first dose of study drug to date of first documented PD, per IMWG criteria, or death due to any cause, whichever occurs first.
Time frame: Every 16 weeks until end of study, participant dies, withdrawn consent, or lost to follow up (up to 18 months)