A Study of SGN-CD228A in Advanced Solid Tumors

Stopped early · Phase 1

Conditions studied: Cutaneous Melanoma, Pleural Mesothelioma, HER2 Negative Breast Neoplasms, Non-small Cell Lung Cancer, Colorectal Cancer, Pancreatic Ductal Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT04042480

Run by

Seagen Inc.

People needed

88

Starts

2019-09-03

Expected to finish

2023-03-09

Last updated by the study team

2023-03-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Advanced pancreatic ductal adenocarcinoma (PDAC):
• Participants must have unresectable or advanced PDAC.
• Participants must have received 1 or more prior line of therapy for locally advanced or metastatic disease unless contraindicated.
• Participants should be able to provide adequate tumor tissue for biomarker analysis
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Measurable disease per Response Evaluation Criteria for Solid Tumors version 1.1 (RECIST v1.1)

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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• The Angeles Clinic and Research Institute — Los Angeles, California, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Wake Forest Baptist Medical Center / Wake Forest University — Winston-Salem, North Carolina, United States
• Case Western Reserve University / University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• Sanford Cancer Center — Sioux Falls, South Dakota, United States
• MD Anderson Cancer Center / University of Texas — Houston, Texas, United States
• South Texas Accelerated Research Therapeutics — San Antonio, Texas, United States
• Institut Gustave Roussy — Villejuif, France
• Istituto Europeo di Oncologia — Milan, Italy
• Hospital Universitario Vall d'Hebron — Barcelona, Spain
• The Royal Marsden Hospital (Surrey) — Sutton, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.