This will be a Phase 1 Open-Label, dose escalation of MT-0169 (an Engineered toxin body (ETB) in patients with relapsed or refractory multiple myeloma. MT-0169 is an investigational drug that recognizes and binds to the CD38 receptor, which may be found on the surface of multiple myeloma cancer cells. It delivers a dose of a modified toxin that kills these cells.
The drug being tested in this study is called MT-0169. The study will evaluate the safety, tolerability, preliminary efficacy, PK, pharmacodynamics, and immunogenicity of MT-0169 monotherapy in participants with RRMM. The study will enroll up to 54 total participants. The purpose of this study is to evaluate the safety and tolerability of MT-0169 in subjects with relapsed or refractory multiple myeloma (RRMM) and to estimate the maximum tolerated dose (MTD) or the recommended Phase 2 dose (RP2D). MT-0169 will be given as an intravenous (IV) infusion over 60 minutes on the same day every week (i.e., days 1, 8, 15 and 22) or every 2 weeks (i.e., days 1 and 15) of each cycle. A cycle is defined as 28 days. A subject may participate for the following three (3) periods: Screening Period - up to 28 days before first dose of MT-0169 Treatment Period - active period where a subject will receive doses of MT-0169 over a 28-day treatment period Follow-up Period - up to 12 months after the last patient in the study to receive the last dose of MT-0169. Participants can receive MT-0169 until the cancer worsens, side effects prevent further study treatment, or until the participant leaves the study for other reasons decided by the participant, the study doctor, or the sponsor of the study. After treatment has finished, participants will have a check-up of their disease status every 12 weeks. This multi-center trial will be conducted in the United States. The overall duration of the study will vary for each participant because they will receive study treatment until unacceptable toxicity, withdrawal of consent, death, termination of the study by the sponsor, or fulfillment of another discontinuation criterion. Participants will be followed up for 30 days after the last dose of study drug for a follow-up assessment for any side effects. Participants will then be followed every 12 weeks to check for the status of their disease up to 12 months after the last subject on the trial has the last dose of study drug, or the sponsor discontinues the study, whichever occurs first.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
14
MT-0169 intravenous infusion.
University of Southern California
Los Angeles, California, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
Miami University
Miami, Florida, United States
Northside Hospital
Atlanta, Georgia, United States
Maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D)
Time frame: Up to 12 months
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 12 months
Number of participants with Dose-limiting Toxicities (DLTs)
Time frame: Up to 12 months
Number of participants with Grade greater than or equal to (>=) 3 TEAEs according to NCI CTCAE 5.0
Time frame: Up to 12 months
Number of participants with Serious Adverse Events (SAEs)
Time frame: Up to 12 months
Number of participants who discontinued MT-0169 due to TEAEs
Time frame: Up to 12 months
Number of participants with treatment-related dose modifications
Dose modifications include dose delays, dose interruptions, and dose reductions
Time frame: Up to 12 months
Cmax: maximum observed concentration for MT-0169
Time frame: Cycles 1 and 2, Day 1: pre-dose, and at multiple time points (up to 168 hours) post-dose (each cycle is 28 days)
Tmax: time to reach maximum observed concentration for MT-0169
Time frame: Cycles 1 and 2, Day 1: pre-dose, and at multiple time points (up to 168 hours) post-dose (each cycle is 28 days)
AUClast: Area Under the Concentration-time Curve From Time 0 to the time of the last quantifiable concentration for MT-0169
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Mayo Clinic - Rochester
Rochester, Minnesota, United States
The Ohio State University
Columbus, Ohio, United States
Vanderbilt University Medical Center- Ingram Cancer Center
Nashville, Tennessee, United States
Time frame: Cycles 1 and 2, Day 1: pre-dose, and at multiple time points (up to 168 hours) post-dose (each cycle is 28 days)
Overall response rate (ORR)
As defined by IMWG Uniform Response Criteria for RRMM patients.
Time frame: Up to 12 months
Clinical Benefit Rate (CBR) for RRMM patients
Percentage of participants who achieved PR or better during study as defined by IMWG Uniform Response Criteria and ORR in patients with RRNHL as defined by the Lugano classification for lymphoma.
Time frame: Up to 12 months
Progression-free Survival (PFS) for RRMM patients
Determined by IMWG criteria
Time frame: From the date of first dose until the date of progressive disease (PD)
Proportion of RRMM participants who achieved MR (minimal response)
MR is defined as the percentage of participants who achieved 25% tumor reduction.
Time frame: Up to 12 months
Duration of Response (DOR)
Time from the date of the first documentation of response to the date of the first documented PD.
Time frame: Date of the dose administration until death due to any cause (up to 12 months)
Number of participants with Anti-drug Antibodies following administration of MT-0169
Time frame: Up to 12 months
Overall survival (OS)
Time frame: From date of the dose administration until death due to any cause (up to 12 months)
Time to Response (TTR)
Time frame: From the date of the first dose of the study treatment to the date of the first documentation of response (up to 12 months)
Percentage of participants with RRMM who achieved Complete Response (CR) or Very Good Partial Response (VGPR)
Time frame: Up to 12 months