NCT03379584

A Safety Study of SGN-CD48A in Patients With Multiple Myeloma

A Phase 1 Study of SGN-CD48A in Patients With Relapsed or Refractory Multiple Myeloma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Seagen Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will test the safety and activity of SGN-CD48A in patients with multiple myeloma. SGN-CD48A will be given on Days 1, 8, and 15 of a 28-day cycle. Prior to protocol amendment 2, SGN-CD48A was given every 3 weeks.

Detailed description

This study is designed to evaluate the safety, tolerability, and antitumor activity of SGN-CD48A in patients with relapsed or refractory multiple myeloma. This study will be conducted in 2 parts: 1. Dose escalation: This part will evaluate increasing doses of SGN-CD48A to identify the maximum tolerated dose. The first group of patients enrolled on the study will receive the lowest dose of SGN-CD48A. Once this dose is shown to be safe, a second group of patients will be enrolled at the next higher dose. Patients will continue to be enrolled in groups receiving increasing doses until the maximum tolerated dose level is reached. Patients can only be enrolled into a higher dose level once the lower doses have been demonstrated safe. Dose escalation will be conducted using a modified toxicity probability interval (mTPI) study design. 2. Dose expansion: This part will further evaluate the safety, tolerability, and antitumor activity of up to 2 dose levels of SGN-CD48A shown to be safe in the first part of the trial.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	SGN-CD48A	Intravenous (IV) infusion on days 1, 8, and 15 of a 28-day cycle

Timeline

• Start date: 2018-02-20
• Primary completion: 2019-08-23
• Completion: 2019-08-23
• First posted: 2017-12-20
• Last updated: 2019-09-18

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study