A Study of SGN-STNV in Advanced Solid Tumors

NCT04665921 | Terminated Phase 1 FDA Drug

• 1 other identifier: SGNSTNV-001
• Study Type: interventional
• Target: 111
• Locations: 6 countries
• Sites: 18

Brief Summary

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.

Conditions

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

Keywords

NSCLC; Non-Small Cell Lung Cancer; HER2-Negative Breast Cancer; High-Grade Serous Ovarian Cancer; HGSOC; Ovarian Cancer; Cervical Cancer; Endometrial Cancer; Esophageal Cancer; Gastric Cancer; GEJ Carcinoma; Colorectal Cancer; Seattle Genetics

Outcome Measures

Primary Outcomes (3)

• Incidence of adverse events (AEs)

  To be summarized using descriptive statistics

  Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years

• Incidence of laboratory abnormalities

  To be summarized using descriptive statistics

  Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years

• Incidence of dose limiting toxicities

  To be summarized using descriptive statistics

  Up to 28 days

Secondary Outcomes (9)

• Objective response rate (ORR) as assessed by the investigator per RECIST v1.1

  Up to approximately 3 years

• Progression-free survival (PFS)

  Up to approximately 3 years

• Overall survival (OS)

  Up to approximately 3 years

• Duration of objective response (DOR)

  Up to approximately 3 years

• Area under the concentration-time curve (AUC)

  Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years

Study Arms (1)

SGN-STNV

EXPERIMENTAL

SGN-STNV monotherapy

Drug: SGN-STNV

Interventions

SGN-STNV DRUG

Given into the vein (IV; intravenously)

SGN-STNV

Eligibility Criteria

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

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

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

Sponsors & Collaborators

• Seagen Inc.: lead

Study Sites (18)

The Angeles Clinic and Research Institute

Los Angeles, California, 90025, United States

Location

University of California, San Francisco | HDFCCC - Hematopoietic Malignancies

San Francisco, California, 94158, United States

Location

Shands Cancer Center / University of Florida

Gainesville, Florida, 32610, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

South Texas Accelerated Research Therapeutics Midwest

Grand Rapids, Michigan, 49546, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239-3098, United States

Location

Magee Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States

Location

University of Ottawa / Ottawa General Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

University Health Network, Princess Margaret Hospital

Toronto, Other, M5G 2C1, Canada

Location

Institut Gustave Roussy

Villejuif, Other, 94805, France

Location

Istituto Europeo di Oncologia

Milan, Other, 20132, Italy

Location

Hospital Universitari Vall d'Hebron

Barcelona, Other, 08035, Spain

Location

The Royal Marsden Hospital (Surrey)

Sutton, Other, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Ovarian Neoplasms; Uterine Cervical Neoplasms; Endometrial Neoplasms; Esophageal Neoplasms; Stomach Neoplasms; Colorectal Neoplasms; Adenocarcinoma, Mucinous; Pseudomyxoma Peritonei

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Cystic, Mucinous, and Serous

Study Officials

• Suzanne McGoldrick, 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: December 7, 2020
• First Posted: December 14, 2020
• Study Start: January 18, 2021
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: February 7, 2025

Record last verified: 2025-02

Locations

US (12); FR (1); IT (1); CA (2); GB (1); ES (1)