A Study of SGN-CD228A in Advanced Solid Tumors

NCT04042480 | Terminated Phase 1 FDA Drug

• 1 other identifier: SGN228-001
• Study Type: interventional
• Target: 88
• Locations: 5 countries
• Sites: 14

Brief Summary

This trial will study SGN-CD228A to find out whether it is an effective treatment for different kinds of cancer. It will also look at what side effects (unwanted effects) may occur. The study will have two parts. Part 1 of the study will find out how much SGN-CD228A should be given for treatment and how often. Part 2 of the study will use the dose found in Part 1 and look at how safe and effective the treatment is.

Conditions

Cutaneous Melanoma; Pleural Mesothelioma; HER2 Negative Breast Neoplasms; Non-small Cell Lung Cancer; Colorectal Cancer; Pancreatic Ductal Adenocarcinoma

Keywords

HER2-negative breast cancer; Seattle Genetics

Outcome Measures

Primary Outcomes (3)

• Number of participants with adverse events

  Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

  Up to approximately 3.5 years

• Number of participants with laboratory abnormalities

  Up to approximately 3.5 years

• Number of participants with dose limiting toxicities

  Up to approximately 3.5 years

Secondary Outcomes (20)

• Best response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

  Up to approximately 3.5 years

• Best response per modified RECIST (mRECIST) (participants with pleural mesothelioma only)

  Up to approximately 3.5 years

• Objective response rate (ORR)

  Up to approximately 3.5 years

• Progression-free survival (PFS)

  Up to approximately 3.5 years

• Overall survival (OS)

  Up to approximately 3.5 years

Study Arms (1)

SGN-CD228A

EXPERIMENTAL

SGN-CD228A monotherapy

Drug: SGN-CD228A

Interventions

SGN-CD228A DRUG

SGN-CD228A administered into the vein (IV; intravenously)

SGN-CD228A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Metastatic or unresectable solid malignancy that is histologically or cytologically confirmed to be one of the tumor types listed below. Participants must have relapsed, refractory, or progressive disease (PD) and should have no appropriate standard therapy available. Disease-specific escalation/expansion includes the following tumor types.
• Metastatic cutaneous melanoma(MCM):
• Metastatic or advanced cutaneous melanoma, excludes acral or mucosal varieties.
• Participants must have received at least 1 PD-1-targeted therapy unless contraindicated.
• Participants with targetable mutations should have received at least 1 therapy targeting that mutation unless contraindicated.
• Malignant pleural mesothelioma (MPM):
• Participants must have received cisplatin and pemetrexed unless contraindicated.
• Advanced HER2-negative breast cancer:
• Participants must have received 1 or more prior lines of therapy for locally advanced or metastatic disease. Prior therapies must include taxane.
• Hormone-receptor-positive subjects should have received CDK4/6 inhibitor therapy and have received at least 1 prior hormonally-directed therapy, unless contraindicated.
• Advanced non-small cell lung cancer (NSCLC):
• Participants must have locally advanced or metastatic EGFR wild-type NSCLC.
• Participants must have received platinum-based therapy and at least 1 PD-1- or PD-L1-targeted therapy as a single agent or as part of a combination unless contraindicated.
• Advanced colorectal cancer:
• Participants must have received 2 or more prior lines of therapy for locally advanced or metastatic disease, including targeted therapies as appropriate.

You may not qualify if:

• History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.
• Pre-existing neuropathy Grade 2 or greater
• Retinal or macular disease requiring treatment or ongoing active monitoring
• Prior receipt of SGN-CD228A or MMAE-containing agents

Sponsors & Collaborators

• Seagen Inc.: lead

Study Sites (14)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

The Angeles Clinic and Research Institute

Los Angeles, California, 90025, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Wake Forest Baptist Medical Center / Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

Case Western Reserve University / University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Sanford Cancer Center

Sioux Falls, South Dakota, 57104, United States

Location

MD Anderson Cancer Center / University of Texas

Houston, Texas, 77030, United States

Location

South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Istituto Europeo di Oncologia

Milan, 20141, Italy

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

The Royal Marsden Hospital (Surrey)

Sutton, SM2 5PT, United Kingdom

Location

Related Publications (1)

• Mazahreh R, Mason ML, Gosink JJ, Olson DJ, Thurman R, Hale C, Westendorf L, Pires TA, Leiske CI, Carlson M, Nguyen LT, Cochran JH, Okeley NM, Yumul R, Jin S, Stone IJ, Sahetya D, Nesterova A, Allred S, Hensley KM, Hu R, Lawrence R, Lewis TS, Sandall S. SGN-CD228A Is an Investigational CD228-Directed Antibody-Drug Conjugate with Potent Antitumor Activity across a Wide Spectrum of Preclinical Solid Tumor Models. Mol Cancer Ther. 2023 Apr 3;22(4):421-434. doi: 10.1158/1535-7163.MCT-22-0401.

  PMID: 36800443 DERIVED

MeSH Terms

Conditions

Melanoma; Mesothelioma, Malignant; Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Anu Gupta, MD

  Seagen Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: August 2, 2019
• Study Start: September 3, 2019
• Primary Completion: March 9, 2023
• Study Completion: March 9, 2023
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (10); IT (1); FR (1); ES (1); GB (1)