Clinical Trials /

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

NCT03957096

Description:

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 1 and look at how safe and effective the treatment is.

Related Conditions:
  • Breast Carcinoma
  • Colorectal Carcinoma
  • Gastric Carcinoma
  • Head and Neck Squamous Cell Carcinoma
  • Melanoma
  • Non-Small Cell Lung Carcinoma
  • Ovarian Carcinoma
  • Pancreatic Adenocarcinoma
  • Soft Tissue Sarcoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: SGN47M-001
  • NCT ID: NCT03957096

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

Interventions

DrugSynonymsArms
SGN-CD47MSGN-CD47M

Purpose

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 1 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.
    

Trial Arms

NameTypeDescriptionInterventions
SGN-CD47MExperimental
  • SGN-CD47M

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

          -  Tumor site accessible for biopsy

          -  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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of patients with adverse events
Time Frame:Up to approximately 24 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Best response per iRECIST
Time Frame:Up to approximately 30 months
Safety Issue:
Description:Defined as the proportion of patients with complete response (CR), partial response (PR), or stable disease (SD) per iRECIST
Measure:Objective response rate (ORR)
Time Frame:Up to approximately 2.5 years
Safety Issue:
Description:Defined as the proportion of patients with CR or PR
Measure:Duration of objective response (DOR)
Time Frame:Up to approximately 2.5 years
Safety Issue:
Description:Defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of confirmed tumor progression or to death due to any cause, whichever comes first
Measure:Duration of complete response
Time Frame:Up to approximately 2.5 years
Safety Issue:
Description: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
Measure:Progression-free survival (PFS)
Time Frame:Up to approximately 2.5 years
Safety Issue:
Description:Defined as the time from start of study treatment to first documentation of confirmed tumor progression or to death due to any cause, whichever comes first
Measure:Overall survival (OS)
Time Frame:Up to approximately 4 years
Safety Issue:
Description:Defined as the time from the start of any study treatment to the date of death due to any cause
Measure:Area under the concentration-time curve (AUC)
Time Frame:Up to approximately 24 months
Safety Issue:
Description:
Measure:Maximum concentration (Cmax)
Time Frame:Up to approximately 24 months
Safety Issue:
Description:
Measure:Time to Cmax (Tmax)
Time Frame:Up to approximately 24 months
Safety Issue:
Description:
Measure:Trough concentration (Ctrough)
Time Frame:Up to approximately 24 months
Safety Issue:
Description:
Measure:Incidence of antidrug antibodies (ADA)
Time Frame:Up to approximately 24 months
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Seattle Genetics, Inc.

Trial Keywords

  • HNSCC
  • NSCLC

Last Updated