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

September 15, 2020 updated by: Seagen Inc.

A Phase 1 Study of SGN-CD47M in Patients With Advanced Solid Tumors

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University / University Hospitals Cleveland Medical Center
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology-Nashvilee/Sarah Cannon Research Institute
    • Texas
      • Houston, Texas, United States, 77030-4095
        • MD Anderson Cancer Center / University of Texas
      • San Antonio, Texas, United States, 78229
        • NEXT Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SGN-CD47M
Drug: SGN-CD47M
SGN-CD47M administered intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with adverse events
Time Frame: Up to approximately 24 months
Up to approximately 24 months
Number of patients with laboratory abnormalities
Time Frame: Up to approximately 24 months
Up to approximately 24 months
Number of patients with dose-limiting toxicities (DLTs)
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR) per RECIST v1.1
Time Frame: Up to approximately 2.5 years
Defined as the proportion of patients with CR or PR
Up to approximately 2.5 years
ORR per iRECIST
Time Frame: Up to approximately 2.5 years
Defined as the proportion of patients with iCR or iPR
Up to approximately 2.5 years
Duration of objective response (DOR) per RECIST v1.1
Time Frame: Up to approximately 2.5 years
Defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever comes first
Up to approximately 2.5 years
DOR per iRECIST
Time Frame: Up to approximately 2.5 years
Up to approximately 2.5 years
Duration of complete response (CR) per RECIST v1.1
Time Frame: Up to approximately 2.5 years
Defined as the time from start of the first documentation of objective tumor response to the first documentation of confirmed tumor progression or to death due to any cause, whichever comes first for the subgroup of patients achieving a CR
Up to approximately 2.5 years
Duration of CR per iRECIST
Time Frame: Up to approximately 2.5 years
Up to approximately 2.5 years
Progression-free survival (PFS) per RECIST v1.1
Time Frame: Up to approximately 2.5 years
Defined as the time from start of study treatment to first documentation of disease progression or to death due to any cause, whichever comes first
Up to approximately 2.5 years
PFS per iRECIST
Time Frame: Up to approximately 2.5 years
Up to approximately 2.5 years
Overall survival (OS)
Time Frame: Up to approximately 4 years
Defined as the time from the start of any study treatment to the date of death due to any cause
Up to approximately 4 years
Area under the concentration-time curve (AUC)
Time Frame: Up to approximately 24 months
Up to approximately 24 months
Maximum concentration (Cmax)
Time Frame: Up to approximately 24 months
Up to approximately 24 months
Time to Cmax (Tmax)
Time Frame: Up to approximately 24 months
Up to approximately 24 months
Trough concentration (Ctrough)
Time Frame: Up to approximately 24 months
Up to approximately 24 months
Incidence of antidrug antibodies (ADA)
Time Frame: Up to approximately 24 months
Up to approximately 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seagen Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 17, 2019

Primary Completion (ACTUAL)

September 14, 2020

Study Completion (ACTUAL)

September 14, 2020

Study Registration Dates

First Submitted

May 17, 2019

First Submitted That Met QC Criteria

May 17, 2019

First Posted (ACTUAL)

May 21, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 17, 2020

Last Update Submitted That Met QC Criteria

September 15, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGN47M-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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