Seattle Genetics‘ investigational therapy SGN-CD48A, being evaluated in a Phase 1 clinical trial for relapsed or refractory multiple myeloma, was successfully delivered to the trial’s first patient, the company announced.
The multicenter open-label trial (NCT03379584) will assess the safety and escalating doses of SGN-CD48A in roughly 75 patients with relapsed or refractory multiple myeloma who have received previous therapy with at least a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody.
SGN-CD48A, developed by Seattle Genetics, is an antibody-drug conjugate (ADC), a new treatment strategy that combines anticancer drugs with selective targeting for cancer cells. In this case, SGN-CD48A targets a protein called CD48 whose levels are elevated at the surface of multiple myeloma cells.
Designed to be highly stable in blood circulation, SGN-CD48A releases an anticancer therapy called monomethyl auristatin E (MMAE) into CD48-expressing cells.
The clinical trial of SGN-CD48A will be conducted in two phases — a dose escalation part followed by a dose expansion phase.
In the first part, patients will receive increasing doses of the therapy to determine its safety. After the first dose is deemed safe, a second group of patients will receive the next higher dose. This will continue until the maximum tolerated dose level is reached. A higher dose will only be administered once the lower doses have been shown to be safe.
In the dose expansion phase, researchers will be evaluating the safety, tolerability, and anti-tumor activity of up to two dose levels of SGN-CD48A that were shown to be safe.
SGN-CD48 is administered intravenously, directly into the bloodstream, every three weeks.
The trial’s primary goal is to assess the safety and tolerability of the treatment and identify its maximum tolerated dose. Secondary endpoints will assess the therapy’s anti-tumor activity and identify the optimal single dose and regimen.
“Multiple myeloma is the second most common blood cancer in the U.S. and remains an incurable disease despite recent medical advances,” Robert Lechleider, MD, senior vice president of clinical development at Seattle Genetics, said in a press release. “Patients are in need of new targeted treatment options that increase durable remissions.”
“SGN-CD48A uses our latest ADC [antibody-drug conjugate] technology, and the initiation of this phase 1 trial in relapsed or refractory multiple myeloma highlights our continued leadership in ADCs as we address this challenging disease,” Lechleider added.
Patients who may want to enroll or know more about the trial can contact Terri Parker at Yale Cancer Center, the study’s principal investigator, by email at [email protected] or by calling 203-737-5312. Or visit the clinical trial’s website here.