- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04665921
A Study of SGN-STNV in Advanced Solid Tumors
A Phase 1 Study of SGN-STNV in Advanced Solid Tumors
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.
Study Overview
Status
Conditions
- Uterine Cervical Neoplasms
- Stomach Neoplasms
- Colorectal Neoplasms
- Esophageal Neoplasms
- Ovarian Neoplasms
- Endometrial Neoplasms
- Pseudomyxoma Peritonei
- Carcinoma, Non-Small Cell Lung
- Gastroesophageal Junction Carcinoma
- HER2 Negative Breast Neoplasms
- Exocrine Pancreatic Adenocarcinoma
- Appendiceal Adenocarcinoma
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Seagen Trial Information Support
- Phone Number: 866-333-7436
- Email: clinicaltrials@seagen.com
Study Locations
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Ontario
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Ottawa, Ontario, Canada, K1H 8L6
- University of Ottawa / Ottawa General Hospital
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Other
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Toronto, Other, Canada, M5G 2C1
- University Health Network, Princess Margaret Hospital
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Other
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Villejuif Cedex, Other, France, 94805
- Institut Gustave Roussy
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Other
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Milano, Other, Italy, 20132
- Istituto Europeo di Oncologia
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Other
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Barcelona, Other, Spain, 08035
- Hospital Universitari Vall d'Hebron
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Other
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Sutton, Other, United Kingdom, SM2 5PT
- The Royal Marsden Hospital (Surrey)
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California
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Los Angeles, California, United States, 90025
- The Angeles Clinic and Research Institute
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San Francisco, California, United States, 94158
- University of California, San Francisco | HDFCCC - Hematopoietic Malignancies
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Florida
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Gainesville, Florida, United States, 32610
- Shands Cancer Center / University of Florida
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Miami, Florida, United States, 33136
- University of Miami
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, United States, 02215
- Dana Farber Cancer Institute
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Michigan
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Grand Rapids, Michigan, United States, 49546
- South Texas Accelerated Research Therapeutics Midwest
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New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Ohio
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Cleveland, Ohio, United States, 44106
- University Hospitals Cleveland Medical Center
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Oregon
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Portland, Oregon, United States, 97239-3098
- Oregon Health and Science University
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- Magee Womens Hospital of UPMC
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Texas
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San Antonio, Texas, United States, 78229
- South Texas Accelerated Research Therapeutics
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
Exclusion Criteria
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: SGN-STNV
SGN-STNV monotherapy
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Given into the vein (IV; intravenously)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Incidence of adverse events (AEs)
Time Frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
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To be summarized using descriptive statistics
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Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
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Incidence of laboratory abnormalities
Time Frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
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To be summarized using descriptive statistics
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Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
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Incidence of dose limiting toxicities
Time Frame: Up to 28 days
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To be summarized using descriptive statistics
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Up to 28 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Objective response rate (ORR) as assessed by the investigator per RECIST v1.1
Time Frame: Up to approximately 3 years
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ORR is defined as the proportion of subjects achieving a partial response (PR) or complete response (CR).
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Up to approximately 3 years
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Progression-free survival (PFS)
Time Frame: Up to approximately 3 years
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PFS is defined as the time from the start of any study treatment to first documentation of disease progression or to death due to any cause, whichever comes first.
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Up to approximately 3 years
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Overall survival (OS)
Time Frame: Up to approximately 3 years
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OS is defined as the time from the start of any study treatment to the date of death due to any cause.
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Up to approximately 3 years
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Duration of objective response (DOR)
Time Frame: Up to approximately 3 years
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DOR is defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression or to death due to any cause, whichever comes first.
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Up to approximately 3 years
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Area under the concentration-time curve (AUC)
Time Frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
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Pharmacokinetic (PK) endpoint
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Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
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Time to maximum concentration (Tmax)
Time Frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
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PK endpoint
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Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
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Maximum concentration (Cmax)
Time Frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
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PK endpoint
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Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
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Trough concentration (Ctrough)
Time Frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
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PK endpoint
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Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
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Incidence of antidrug antibodies (ADA)
Time Frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
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Immunogenicity endpoint
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Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Suzanne McGoldrick, MD, Seagen Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Skin Diseases
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Lung Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Endocrine Gland Neoplasms
- Breast Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Head and Neck Neoplasms
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Esophageal Diseases
- Lung Neoplasms
- Neoplasms, Cystic, Mucinous, and Serous
- Adenocarcinoma, Mucinous
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Neoplasms
- Uterine Cervical Neoplasms
- Stomach Neoplasms
- Breast Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Carcinoma
- Colorectal Neoplasms
- Adenocarcinoma
- Ovarian Neoplasms
- Endometrial Neoplasms
- Esophageal Neoplasms
- Pseudomyxoma Peritonei
Other Study ID Numbers
- SGNSTNV-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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