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

Seagen

Status and phase

Terminated

Phase 1

Conditions

Multiple Myeloma

Treatments

Drug: SGN-CD48A

Study type

Interventional

Funder types

Industry

Identifiers

NCT03379584

SGN48A-001

Details and patient eligibility

About

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.

Full 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:

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.
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.

Enrollment

14 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of MM requiring systemic therapy (per the International Myeloma Working Group [IMWG])
Patients must not have other therapeutic options known to provide clinical benefit in MM available to them. Prior lines of therapy must include at least a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody.
Measureable disease, as defined by at least one of the following: serum M protein 0.5 g/dL or higher, urine M protein 200 mg/24 hour or higher, and serum immunoglobulin free light chain 10 mg/dL or higher and abnormal serum immunoglobulin kappa lambda free light chain ratio
Adequate hematologic, renal, and hepatic function
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life expectancy greater than 3 months
A negative pregnancy test (for females of childbearing potential)
Patients must provide written consent

Exclusion criteria

Pre-existing peripheral neuropathy Grade 2 or higher
History of malignancy other than MM within the past 3 years
Active cerebral/meningeal disease related to the underlying malignancy
Uncontrolled Grade 3 or higher infection
Known to be positive for HIV or hepatitis B, or known to have active hepatitis C infection
Previous allogeneic stem cell transplant
History of cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms consistent with congestive heart failure within the last 6 months
Treatment with any known P-gp inducers/inhibitors or strong CYP3A inhibitors within 14 days prior to the first dose of study drug
Prior antitumor therapy that is not completed at least 4 weeks prior to first dose of study drug, or at least 2 weeks if progressing. Prior CAR T-cell therapy must be completed 8 weeks before first dose of study drug.
Females who are pregnant or breastfeeding