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

Sponsor

Seagen Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT03957096

Collaborator

(none)

Enrollment

Locations

Arm

Actual Duration (Months)

3.2

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
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	Drug: SGN-CD47M	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 17, 2019

Actual Primary Completion Date :

Sep 14, 2020

Actual Study Completion Date :

Sep 14, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SGN-CD47M	Drug: SGN-CD47M SGN-CD47M administered intravenously

Arm

Intervention/Treatment

Experimental: SGN-CD47M

Drug: SGN-CD47M

SGN-CD47M administered intravenously

Outcome Measures

Primary Outcome Measures

Number of patients with adverse events [Up to approximately 24 months]
Number of patients with laboratory abnormalities [Up to approximately 24 months]
Number of patients with dose-limiting toxicities (DLTs) [28 days]

Secondary Outcome Measures

Objective response rate (ORR) per RECIST v1.1 [Up to approximately 2.5 years]
Defined as the proportion of patients with CR or PR
ORR per iRECIST [Up to approximately 2.5 years]
Defined as the proportion of patients with iCR or iPR
Duration of objective response (DOR) per RECIST v1.1 [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
DOR per iRECIST [Up to approximately 2.5 years]
Duration of complete response (CR) per RECIST v1.1 [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
Duration of CR per iRECIST [Up to approximately 2.5 years]
Progression-free survival (PFS) per RECIST v1.1 [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
PFS per iRECIST [Up to approximately 2.5 years]
Overall survival (OS) [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
Area under the concentration-time curve (AUC) [Up to approximately 24 months]
Maximum concentration (Cmax) [Up to approximately 24 months]
Time to Cmax (Tmax) [Up to approximately 24 months]
Trough concentration (Ctrough) [Up to approximately 24 months]
Incidence of antidrug antibodies (ADA) [Up to approximately 24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Case Western Reserve University / University Hospitals Cleveland Medical Center	Cleveland	Ohio	United States	44106
2	Providence Portland Medical Center	Portland	Oregon	United States	97213
3	Tennessee Oncology-Nashvilee/Sarah Cannon Research Institute	Nashville	Tennessee	United States	37203
4	MD Anderson Cancer Center / University of Texas	Houston	Texas	United States	77030-4095
5	NEXT Oncology	San Antonio	Texas	United States	78229