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

  • STATUS
    Not Recruiting
  • End date
    Sep 30, 2022
  • participants needed
    205
  • sponsor
    Seattle Genetics, Inc.
Updated on 25 January 2021
carcinoma
squamous cell carcinoma
progressive disease
adenocarcinoma
solid tumour
breast carcinoma
squamous cell carcinoma of head and neck
sarcoma
ovarian carcinoma
soft tissue sarcoma
lung carcinoma

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.

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.

Details
Condition Ductal Carcinoma In Situ, Non-Small Cell Lung Cancer, Colorectal Cancer, Connective and Soft Tissue Neoplasm, Rectal disorder, Breast Cancer, Ovarian Cancer, melanoma, skin cancer, Sarcoma, Metastatic Melanoma, All Solid Tumors, Colon Cancer Screening, Rectal Disorders, Solid Tumors, Colon cancer; rectal cancer, Head and Neck Squamous Cell Carcinoma, Gastric Carcinoma, Recurrent Ovarian Cancer, Ductal Carcinoma In Situ (DCIS), Sarcoma (Pediatric), Malignant Melanoma, Soft Tissue Sarcoma, Exocrine Pancreatic Carcinoma
Treatment SGN-CD47M
Clinical Study IdentifierNCT03957096
SponsorSeattle Genetics, Inc.
Last Modified on25 January 2021

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