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A Study of SGN-STNV in Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04665921
Recruitment Status : Recruiting
First Posted : December 14, 2020
Last Update Posted : June 14, 2022
Sponsor:
Information provided by (Responsible Party):
Seagen Inc.

Study Description
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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.


Condition or disease Intervention/treatment Phase
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 Drug: SGN-STNV Phase 1

Detailed Description:
The study will include dose escalation (Part A) and dose expansion (Part B), with multiple disease-specific cohorts and a biology cohort in dose expansion. The biology cohort will require additional biopsies. At the completion of dose escalation, up to 5 disease specific expansion cohorts and 1 biology expansion cohort may be activated by the sponsor in consultation with the Safety Monitoring Committee (SMC). Expansion cohorts in Part B will enroll subjects with selected tumors that are eligible for enrollment in Part A. The dose(s) to be examined in Part B will be at or below the maximum tolerated dose and/or the recommended dose determined in Part A. The recommended dose and/or schedule may differ between cohorts.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 315 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of SGN-STNV in Advanced Solid Tumors
Actual Study Start Date : January 18, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: SGN-STNV
SGN-STNV monotherapy
 Drug: SGN-STNV
Given into the vein (IV; intravenously)


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of adverse events (AEs) [ Time Frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years ]
    To be summarized using descriptive statistics

  2. Incidence of laboratory abnormalities [ Time Frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years ]
    To be summarized using descriptive statistics

  3. Incidence of dose limiting toxicities [ Time Frame: Up to 28 days ]
    To be summarized using descriptive statistics


Secondary Outcome Measures :
  1. Objective response rate (ORR) as assessed by the investigator per RECIST v1.1 [ Time Frame: Up to approximately 3 years ]
    ORR is defined as the proportion of subjects achieving a partial response (PR) or complete response (CR).

  2. Progression-free survival (PFS) [ Time Frame: Up to approximately 3 years ]
    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.

  3. Overall survival (OS) [ Time Frame: Up to approximately 3 years ]
    OS is defined as the time from the start of any study treatment to the date of death due to any cause.

  4. Duration of objective response (DOR) [ Time Frame: Up to approximately 3 years ]
    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.

  5. Area under the concentration-time curve (AUC) [ Time Frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years ]
    Pharmacokinetic (PK) endpoint

  6. Time to maximum concentration (Tmax) [ Time Frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years ]
    PK endpoint

  7. Maximum concentration (Cmax) [ Time Frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years ]
    PK endpoint

  8. Trough concentration (Ctrough) [ Time Frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years ]
    PK endpoint

  9. Incidence of antidrug antibodies (ADA) [ Time Frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years ]
    Immunogenicity endpoint


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 a tumor site accessible for biopsy and agree to biopsy as follows:

    • Disease-specific expansion cohorts: pre-treatment biopsy
    • Biology expansion cohort: pretreatment biopsy and additional on-treatment biopsy during Cycle 1
  • 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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04665921


Contacts
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Contact: Seagen Trial Information Support 866-333-7436 clinicaltrials@seagen.com

Locations
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United States, California
Angeles Clinic and Research Institute, The Recruiting
Los Angeles, California, United States, 90025
Principal Investigator: Ani Balmanoukian         
Principal Investigator: Vi K Chiu         
University of California at San Francisco Recruiting
San Francisco, California, United States, 94158
Contact: Nela Pawlowska    415-353-8337      
Principal Investigator: Pamela Munster         
United States, Florida
Shands Cancer Center / University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Taryn King         
Principal Investigator: Thomas George         
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Silvia Garcia    305-243-3009      
Principal Investigator: Marilyn Huang         
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Matthew Gailloud    617-975-7451      
Principal Investigator: Gerburg Wulf         
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Khaoula Ben Haj Frej    617-632-6914      
Principal Investigator: Khanh Do         
Principal Investigator: Elizabeth K Lee, MD         
United States, Michigan
South Texas Accelerated Research Therapeutics Midwest Recruiting
Grand Rapids, Michigan, United States, 49546
Contact: Katie Robinson    616-389-1739      
Principal Investigator: Nehal Lakhani, MD, PhD         
United States, Ohio
Case Western Reserve University / University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Cancer Information Services Inbox    800-641-2422      
Principal Investigator: Afshin Dowlati         
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239-3098
Contact: Shruthie Gnaneswaran    503-418-1815      
Principal Investigator: Shivaani Kummar         
United States, Texas
South Texas Accelerated Research Therapeutics Recruiting
San Antonio, Texas, United States, 78229
Contact: Isabel Jimenez    210-593-5265    isabel.jimenez@startsa.com   
Principal Investigator: Amita Patnaik         
Canada, Ontario
University of Ottawa / Ottawa General Hospital Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Principal Investigator: Scott Laurie, MD         
Principal Investigator: Arif Awan         
Canada, Other
University Health Network, Princess Margaret Hospital Recruiting
Toronto, Other, Canada, M5G 2C1
Principal Investigator: Neesha Dhani, MD         
France
Institut Gustave Roussy Recruiting
Villejuif Cedex, Other, France, 94805
Principal Investigator: Capucine Baldini         
Italy
Istituto Europeo di Oncologia Recruiting
Milan, Other, Italy, 20141
Principal Investigator: Giuseppe Curigliano         
Spain
Hospital Universitario Vall d'Hebron Recruiting
Barcelona, Other, Spain, 08035
Principal Investigator: Irene Brana         
Principal Investigator: Elena Garralda Cabanas         
United Kingdom
The Royal Marsden Hospital (Surrey) Recruiting
Sutton, Other, United Kingdom, SM2 5PT
Principal Investigator: Anna Minchom         
Sponsors and Collaborators
Seagen Inc.
Investigators
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Study Director: Suzanne McGoldrick, MD Seagen Inc.
More Information
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Responsible Party: Seagen Inc.
ClinicalTrials.gov Identifier: NCT04665921    
Other Study ID Numbers: SGNSTNV-001
First Posted: December 14, 2020    Key Record Dates
Last Update Posted: June 14, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seagen Inc.:
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
Additional relevant MeSH terms:
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Carcinoma
Neoplasms
Adenocarcinoma
Breast Neoplasms
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Ovarian Neoplasms
Stomach Neoplasms
Esophageal Neoplasms
Uterine Cervical Neoplasms
Endometrial Neoplasms
Pseudomyxoma Peritonei
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
 Breast Diseases
Skin Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases