Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Digestive System Diseases

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Squamous Cell

Stomach Neoplasms

Breast Neoplasms

Pancreatic Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Melanoma

Sarcoma

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Skin Diseases

Neoplasms, Connective and Soft Tissue

Breast Diseases

Head and Neck Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Endocrine Gland Neoplasms

Endocrine System Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Pancreatic Diseases

Stomach Diseases

Stomach Cancer

Pancreatic Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Soft Tissue Sarcoma

SGN-CD47M

Michael Schmitt, MD, PhD

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.

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.

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

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

Defined as the proportion of patients with CR or PR

Defined as the proportion of patients with iCR or iPR

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

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

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

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

Seagen Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Safety Study of SGN-CD47M in Patients With Solid Tumors	NCT03957096	Soft Tissue Sar... Colorectal Canc... Head and Neck S... Non-small Cell ... Breast Carcinom... Ovarian Carcino... Exocrine Pancre... Gastric Carcino... Melanoma	SGN-CD47M	18 Years -	Seagen Inc.
A Safety Study of SGN-CD47M in Patients With Solid Tumors	NCT03957096	Soft Tissue Sar... Colorectal Canc... Head and Neck S... Non-small Cell ... Breast Carcinom... Ovarian Carcino... Exocrine Pancre... Gastric Carcino... Melanoma	SGN-CD47M	18 Years -	Seagen Inc.

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