The goal of this clinical trial is to determine the safest and most effective dose of Modakafusp Alfa when given by itself and when combined with Dexamethasone to patients who have relapsed / refractory Multiple Myeloma.
This trial is currently open and accepting patients.
This trial is being conducted in three different parts, and Part 3 is currently enrolling. The goal of this part of the trial is to learn if two different doses of Modakafusp Alfa are safe and how well they work in treating relapsed or refractory multiple myeloma. This part of the trial will enroll approximately 236 patients.
Participants in this part of the trial will receive treatment organized into 28-day cycles and will receive Modakafusp Alfa by intravenous infusion monthly at one of two different doses. This trial is open label, which means that both the participants and health care providers will know which dose they are receiving.
Participants in this trial may continue to participate as long as they don’t develop bad side effects, and their myeloma doesn’t get worse.
The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.
Enrollment: 336 patients (estimated)View More
June 11, 2022
As of Oct 2021, 30 pts had received modakafusp alfa 1.5 mg/kg Q4W. The median number of prior lines was 7 (range 3–16); 90% of pts were refractory to an anti-CD38 monoclonal antibody (mAb), while 37% were exposed to an anti-B-cell maturation agent (BCMA). Grade (G) 3–4 treatment-emergent adverse events (TEAEs) were reported in 25 pts (83%); the most frequent G3–4 TEAEs were neutropenia in 19 (63%), thrombocytopenia in 13 (43%), leukopenia in 12 (40%), anemia in 9 (30%), and decreased lymphocyte count in 9 (30%) pts. As reported previously, 1 pt in the 1.5 mg/kg Q4W cohort had a G3 bleeding event, while 3 pts had G3 infections. Among all pts, the ORR was 40% (complete response, 7%; very good partial response, 20%; partial response, 13%); among anti-CD38 mAb-refractory and anti BMCA-exposed pts, the ORR was 37% and 27%, respectively. Median progression-free survival was 6 mos and median duration of response had not been reached (Kaplan-Meier estimate, 91% at 6 mos). Based on pooled available data for the Q3W and Q4W cohorts (all doses) within the escalation and expansion phases, there was a strong trend for a dose-exposure-response relationship for ORR, with the apparent inflection point at 1.5 mg/kg Q4W dosing. No apparent relationship between dose-exposure-response and G3/4 thrombocytopenia or neutropenia was observed across all doses, whereas a correlation between dose-exposure-response and incidence of infusion-related reactions across the 0.4–6 mg/kg Q3W and Q4W dosing cohorts was found. There was an apparent non-linear (more than dose proportional) increase in exposure in the dose range of 0.1–3 mg/kg with a geometric mean terminal half-life of 13 hours in serum for modakafusp alfa 1.5 mg/kg. Based on the available data, 14% and 60% of pts were ADA positive at baseline and post-treatment, respectively.
December 13, 2021
As of May 2021, 83 pts had been treated across all planned dosing schedules. With Q4W dosing, the MTD was exceeded at the 6 mg/kg dose due to DLTs: a grade 3 infusion reaction and prolonged thrombocytopenia and neutropenia, which delayed the start of cycle 2 by >14 days. In total, 24 pts were treated with 1.5 mg/kg modakafusp alfa Q4W (5 pts during dose escalation and 19 pts in an expansion cohort). Analyses include data from all 24 pts. The median number of prior lines of therapy received was 6 (range 4–16); 21 pts (88%) were refractory to an anti-CD38 mAb, and 20 (83%) were triple class-refractory (to a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 mAb). Grade 3 or higher treatment-emergent adverse events (TEAEs) were reported in 18 pts (75%). The most frequent grade 3–4 TEAEs were neutropenia in 12 pts (50%; grade 4 in 6 [25%]), leukopenia in 9 (38%), decreased lymphocyte count in 9 (38%), anemia in 8 (33%), and thrombocytopenia in 8 (33%; grade 4 in 3 [13%]). One pt (4%) had a grade 3 bleeding event and continues on study treatment; 3 pts (13%) had infections (grade 3 in 2 [8%]); and 8 (33%) had infusion reactions (grade 3 in 1 [4%]). The overall response rate (ORR, ≥partial response [PR]) was 42% (complete response [CR], n=2; very good partial response [VGPR], n=5; PR, n=3), and the clinical benefit rate (ORR + minimal response [MR]) was 54% (MR, n=3). Median progression-free survival was 5.7 months (95% confidence interval [CI], 1.9–not reached [NR]), median time to response was 1.9 months (95% CI, 0.95–NR), and median duration of response was 7.4 months (95% CI, 2.3–NR). Among the 21 anti-CD38 mAb-refractory pts, the ORR was 43%, while among the 4 pts who received an anti-CD38 mAb in their most recent line of therapy prior to enrollment, the ORR was 75% (CR, n=1; VGPR, n=2). Correlative studies show evidence of T-cell and natural killer-cell activation, as well as activation of IFN signaling in CD38+ cells, including upregulation of CD38 expression.
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