A Study of SGN-STNV in Advanced Solid Tumors

Stopped early · Phase 1

Conditions studied: Carcinoma, Non-Small Cell Lung, HER2 Negative Breast Neoplasms, Ovarian Neoplasms, Uterine Cervical Neoplasms, Endometrial Neoplasms, Esophageal Neoplasms, Gastroesophageal Junction Carcinoma, Stomach Neoplasms, Colorectal Neoplasms, Exocrine Pancreatic Adenocarcinoma, Appendiceal Adenocarcinoma, Pseudomyxoma Peritonei

In brief

This trial will look at a drug called SGN-STNV to find out whether it is safe for patients with solid tumors. It will study SGN-STNV to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study how well SGN-STNV works to treat solid tumors. The study will have two parts. Part A of the study will find out how much SGN-STNV should be given to patients. Part B will use the dose found in Part A to find out how safe SGN-STNV is and if it works to treat certain types of solid tumors.

Key facts

Study ID

NCT04665921

Run by

Seagen Inc.

People needed

111

Starts

2021-01-18

Expected to finish

2024-03-01

Last updated by the study team

2025-02-07

Who can join

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

You may qualify if…

• Disease indication
• Must have disease that is relapsed or refractory or be intolerant to standard-of-care therapies and should have no appropriate standard-of-care therapeutic option.
• Non-small cell lung cancer (NSCLC)
• HER2 negative breast cancer
• Ovarian cancer
• Cervical cancer
• Endometrial cancer
• Esophageal cancer
• Gastric cancer and GEJ carcinoma
• Colorectal cancer
• Exocrine pancreatic adenocarcinoma
• Appendiceal adenocarcinoma and pseudomyxoma peritonei of unknown origin
• Participants enrolled in the following study parts should have an appropriate tumor site that satisfies the following criteria:
• Site has tumor that is not a target lesion and has not been previously irradiated (unless progression has occurred since end of radiotherapy)
• Site has tumor that is accessible for a minimally invasive biopsy that does not present a significant risk, AND
• Participant must agree to a biopsy as follows
• Disease-specific expansion cohorts: pre-treatment biopsy, unless medically infeasible following consultation with the medical monitor
• Biology expansion cohort: pretreatment biopsy (required) and additional on-treatment biopsy during Cycle 1 (unless medically infeasible following consultation with the medical monitor)
• Measurable disease per the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) at baseline
• An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
• Adequate renal, hepatic, and hematologic function

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.
• Known active central nervous system metastases
• Carcinomatous meningitis
• Previous receipt of monomethylauristatin E (MMAE)-containing drugs
• Pre-existing neuropathy ≥ Grade 2 per the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
• Any uncontrolled ≥ Grade 3 (per the NCI CTCAE, Version 5.0) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of SGN-STNV
• There are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met.

Where it is running

• The Angeles Clinic and Research Institute — Los Angeles, California, United States
• University of California, San Francisco | HDFCCC - Hematopoietic Malignancies — San Francisco, California, United States
• Shands Cancer Center / University of Florida — Gainesville, Florida, United States
• University of Miami — Miami, Florida, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• South Texas Accelerated Research Therapeutics Midwest — Grand Rapids, Michigan, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Magee Womens Hospital of UPMC — Pittsburgh, Pennsylvania, United States
• South Texas Accelerated Research Therapeutics — San Antonio, Texas, United States
• University of Ottawa / Ottawa General Hospital — Ottawa, Ontario, Canada
• University Health Network, Princess Margaret Hospital — Toronto, Other, Canada
• Institut Gustave Roussy — Villejuif, Other, France
• Istituto Europeo di Oncologia — Milan, Other, Italy
• Hospital Universitari Vall d'Hebron — Barcelona, Other, Spain
• The Royal Marsden Hospital (Surrey) — Sutton, Other, United Kingdom

Full record on ClinicalTrials.gov

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