A Safety Study of SGN-CD47M in Patients With Solid Tumors

NCT ID: NCT03957096

Last Updated: 2020-09-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-17
• Study Completion Date: 2020-09-14

Brief Summary

This trial will study SGN-CD47M to find out whether it is an effective treatment for different types of solid tumors and what side effects (unwanted effects) may occur. The study will have two parts. Part A of the study will find out how much SGN-CD47M should be given for treatment and how often. Part B of the study will use the dose found in Part A and look at how safe and effective the treatment is.

Detailed Description

This is a dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of SGN-CD47M in adults with advanced solid tumors. The study will be conducted in 2 parts:

Part A - Dose escalation: Up to approximately 25 patients will be treated to evaluate the safety, tolerability, and PK of SGN-CD47M, and to identify the maximum tolerated dose (MTD) and/or optimal dose.

Part B - Dose expansion: Up to approximately 180 patients will be treated in expansion cohorts at the MTD or optimal dose to further characterize the safety, PK, and antitumor activity of SGN-CD47M.

In eligible patients, standard therapies must have failed, been intolerable, or been considered medically inappropriate by the investigator. If the MTD is not reached in Part A, safety, PK, pharmacodynamic, and biomarker analyses, as well as preliminary antitumor activity, will be used to determine the optimal dose. Patients in Part A may continue on treatment until confirmed progressive disease (PD) or unacceptable toxicity, whichever occurs first. The dose(s) to be examined in Part B will be at or below the MTD and/or the optimal dose determined in Part A.

Conditions

Soft Tissue Sarcoma; Colorectal Cancer; Head and Neck Squamous Cell Carcinoma; Non-small Cell Lung Carcinoma; Breast Carcinoma; Ovarian Carcinoma; Exocrine Pancreatic Carcinoma; Gastric Carcinoma; Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SGN-CD47M

Group Type: EXPERIMENTAL

SGN-CD47M

Intervention Type: DRUG

SGN-CD47M administered intravenously

Interventions

SGN-CD47M

SGN-CD47M administered intravenously

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologically or cytologically confirmed metastatic or unresectable solid malignancy within one of the following indications:

1. Soft tissue sarcoma

2. Colorectal carcinoma

3. Non-small cell lung carcinoma

4. Head and neck squamous cell carcinoma

5. Breast carcinoma

6. Ovarian carcinoma

7. Exocrine pancreatic adenocarcinoma

8. Gastric carcinoma

9. Melanoma

• Relapsed, refractory, or progressive disease with no appropriate standard therapy available at the time of enrollment
• ECOG performance status of 0 or 1
• Measureable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at baseline
• Patients of childbearing potential may not be pregnant, must agree not to become pregnant until at 30 days after last dose of study drug, and must use 2 effective means of birth control.
• Patients who can father children must use 2 effective means of birth control and must agree not to donate sperm until at least 60 days after last dose of study drug.

Exclusion Criteria

• History of another malignancy within 3 years prior to first dose of study drug (exceptions for malignancies with negligible risk of metastasis)
• Previous exposure to CD47 or SIRPα targeted therapy
• Chemotherapy, systemic radiotherapy, biologics, other anti-neoplastic or investigational agents, and/or other antitumor treatment with immunotherapy that is not completed 4 weeks prior to first dose of SGN-CD47M. Focal radiotherapy that is not completed 2 weeks prior to the first dose of SGN-CD47M
• Known active central nervous system metastases
• Positive for hepatitis B, active hepatitis C infections, positive for human immunodeficiency virus (HIV), or known active or latent tuberculosis
• History of sickle cell anemia, auto-immune hemolytic anemia, or idiopathic thrombocytopenic purpura
• Carcinomatous meningitis
• Red blood cell transfusion within 4 weeks prior to enrollment or platelet transfusion within 2 weeks prior to enrollment
• Any active Grade 3 or higher viral, bacterial, or fungal infection within 2 weeks prior to first dose
• History of a cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association Class III-IV within 6 months prior to first dose
• Condition requiring systemic treatment with corticosteroids or other immunosuppressive medications within 2 week prior to first dose
• Active autoimmune disease, autoimmune-related toxicity from prior immuno-oncology-based therapy
• Estimated life expectancy of less than 12 weeks

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seagen Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Schmitt, MD, PhD

Role: STUDY_DIRECTOR

Seagen Inc.

Locations

Case Western Reserve University / University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Providence Portland Medical Center

Portland, Oregon, United States

Tennessee Oncology-Nashvilee/Sarah Cannon Research Institute

Nashville, Tennessee, United States

MD Anderson Cancer Center / University of Texas

Houston, Texas, United States

NEXT Oncology

San Antonio, Texas, United States

Countries

United States

Other Identifiers

SGN47M-001

Identifier Type: -

Identifier Source: org_study_id