NCT02954796

A Safety Study of SGN-CD352A for Patients With Relapsed/Refractory Multiple Myeloma

Phase 1 Study of SGN-CD352A in Patients With Relapsed or Refractory Multiple Myeloma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Seagen Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study tests the safety of a drug called SGN-CD352A, to find out what its side effects are. SGN-CD352A will be given every 4 weeks to a small group of patients with multiple myeloma.

Detailed description

The study will have 2 parts. In the first part, different doses of SGN-CD352A will be given to different patients (each individual patient will get the same dose for all treatments). The doses will be very low at the start of the trial, and will increase only when the lower dose levels are proven safe. In the second part of the study, up to 2 dose levels that are both safe and show promising activity against MM will be given to more patients

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	SGN-CD352A	On the first day of each 28-day cycle, SGN-CD352A will be given IV. The dose of SGN-CD352A is different in each cohort of the study, with the lowest dose in Cohort -1 (4 mcg/kg) and the highest in Cohort 6 (65 mcg/kg). Patients can only be enrolled into a higher dose level arm if lower doses have proven safe.

Timeline

• Start date: 2016-12-01
• Primary completion: 2019-07-17
• Completion: 2019-07-17
• First posted: 2016-11-03
• Last updated: 2019-08-12

Locations

11 sites across 1 country: United States