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

Primary Purpose

Soft Tissue Sarcoma, Colorectal Cancer, Head and Neck Squamous Cell Carcinoma

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

SGN-CD47M

About this trial

This is an interventional treatment trial for Soft Tissue Sarcoma focused on measuring HNSCC, NSCLC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Case Western Reserve University / University Hospitals Cleveland Medical Center
Providence Portland Medical Center
Tennessee Oncology-Nashvilee/Sarah Cannon Research Institute
MD Anderson Cancer Center / University of Texas
NEXT Oncology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SGN-CD47M

Arm Description

Outcomes

Primary Outcome Measures

Number of patients with adverse events

Number of patients with laboratory abnormalities

Number of patients with dose-limiting toxicities (DLTs)

Secondary Outcome Measures

Objective response rate (ORR) per RECIST v1.1

Defined as the proportion of patients with CR or PR

ORR per iRECIST

Defined as the proportion of patients with iCR or iPR

Duration of objective response (DOR) per RECIST v1.1

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

DOR per iRECIST

Duration of complete response (CR) per RECIST v1.1

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

Duration of CR per iRECIST

Progression-free survival (PFS) per RECIST v1.1

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

PFS per iRECIST

Overall survival (OS)

Defined as the time from the start of any study treatment to the date of death due to any cause

Area under the concentration-time curve (AUC)

Maximum concentration (Cmax)

Time to Cmax (Tmax)

Trough concentration (Ctrough)

Incidence of antidrug antibodies (ADA)

Full Information

NCT ID

NCT03957096

First Posted

May 17, 2019

Last Updated

September 15, 2020

Sponsor

Seagen Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03957096

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Terminated

Why Stopped

Sponsor decision based on portfolio prioritization

Study Start Date

July 17, 2019 (Actual)

Primary Completion Date

September 14, 2020 (Actual)

Study Completion Date

September 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Seagen Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

HNSCC, NSCLC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SGN-CD47M

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

SGN-CD47M

Intervention Description

SGN-CD47M administered intravenously

Primary Outcome Measure Information:

Title

Number of patients with adverse events

Time Frame

Up to approximately 24 months

Title

Number of patients with laboratory abnormalities

Time Frame

Up to approximately 24 months

Title

Number of patients with dose-limiting toxicities (DLTs)

Time Frame

28 days

Secondary Outcome Measure Information:

Title

Objective response rate (ORR) per RECIST v1.1

Description

Defined as the proportion of patients with CR or PR

Time Frame

Up to approximately 2.5 years

Title

ORR per iRECIST

Description

Defined as the proportion of patients with iCR or iPR

Time Frame

Up to approximately 2.5 years

Title

Duration of objective response (DOR) per RECIST v1.1

Description

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

Time Frame

Up to approximately 2.5 years

Title

DOR per iRECIST

Time Frame

Up to approximately 2.5 years

Title

Duration of complete response (CR) per RECIST v1.1

Description

Time Frame

Up to approximately 2.5 years

Title

Duration of CR per iRECIST

Time Frame

Up to approximately 2.5 years

Title

Progression-free survival (PFS) per RECIST v1.1

Description

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

Time Frame

Up to approximately 2.5 years

Title

PFS per iRECIST

Time Frame

Up to approximately 2.5 years

Title

Overall survival (OS)

Description

Defined as the time from the start of any study treatment to the date of death due to any cause

Time Frame

Up to approximately 4 years

Title

Area under the concentration-time curve (AUC)

Time Frame

Up to approximately 24 months

Title

Maximum concentration (Cmax)

Time Frame

Up to approximately 24 months

Title

Time to Cmax (Tmax)

Time Frame

Up to approximately 24 months

Title

Trough concentration (Ctrough)

Time Frame

Up to approximately 24 months

Title

Incidence of antidrug antibodies (ADA)

Time Frame

Up to approximately 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically or cytologically confirmed metastatic or unresectable solid malignancy within one of the following indications: Soft tissue sarcoma Colorectal carcinoma Non-small cell lung carcinoma Head and neck squamous cell carcinoma Breast carcinoma Ovarian carcinoma Exocrine pancreatic adenocarcinoma Gastric carcinoma 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Schmitt, MD, PhD

Organizational Affiliation

Seagen Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Case Western Reserve University / University Hospitals Cleveland Medical Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

Providence Portland Medical Center

City

Portland

State/Province

Oregon

ZIP/Postal Code

97213

Country

United States

Facility Name

Tennessee Oncology-Nashvilee/Sarah Cannon Research Institute

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

MD Anderson Cancer Center / University of Texas

City

Houston

State/Province

Texas

ZIP/Postal Code

77030-4095

Country

United States

Facility Name

NEXT Oncology

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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