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: Terminated
• 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: Drug: SGN-STNV

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 Type: Interventional
• Enrollment (Actual): 111
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • University of Ottawa / Ottawa General Hospital
  • Other
    • Toronto, Other, Canada, M5G 2C1
      • University Health Network, Princess Margaret Hospital
• France
  • Other
    • Villejuif Cedex, Other, France, 94805
      • Institut Gustave Roussy
• Italy
  • Other
    • Milano, Other, Italy, 20132
      • Istituto Europeo Di Oncologia
• Spain
  • Other
    • Barcelona, Other, Spain, 08035
      • Hospital Universitari Vall d'Hebron
• United Kingdom
  • Other
    • Sutton, Other, United Kingdom, SM2 5PT
      • The Royal Marsden Hospital (Surrey)
• United States
  • California
    • Los Angeles, California, United States, 90025
      • The Angeles Clinic and Research Institute
    • San Francisco, California, United States, 94158
      • University of California, San Francisco | HDFCCC - Hematopoietic Malignancies
  • Florida
    • Gainesville, Florida, United States, 32610
      • Shands Cancer Center / University of Florida
    • Miami, Florida, United States, 33136
      • University of Miami
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute
  • Michigan
    • Grand Rapids, Michigan, United States, 49546
      • South Texas Accelerated Research Therapeutics Midwest
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
  • Oregon
    • Portland, Oregon, United States, 97239-3098
      • Oregon Health and Science University
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee Womens Hospital of UPMC
  • Texas
    • San Antonio, Texas, United States, 78229
      • South Texas Accelerated Research Therapeutics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SGN-STNV; SGN-STNV monotherapy	Drug: SGN-STNV; Given into the vein (IV; intravenously)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR) as assessed by the investigator per RECIST v1.1	ORR is defined as the proportion of subjects achieving a partial response (PR) or complete response (CR).	Up to approximately 3 years
Progression-free survival (PFS)	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.	Up to approximately 3 years
Overall survival (OS)	OS is defined as the time from the start of any study treatment to the date of death due to any cause.	Up to approximately 3 years
Duration of objective response (DOR)	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.	Up to approximately 3 years
Area under the concentration-time curve (AUC)	Pharmacokinetic (PK) endpoint	Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
Time to maximum concentration (Tmax)	PK endpoint	Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
Maximum concentration (Cmax)	PK endpoint	Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
Trough concentration (Ctrough)	PK endpoint	Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
Incidence of antidrug antibodies (ADA)	Immunogenicity endpoint	Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years

Collaborators and Investigators

• Sponsor: Seagen Inc.
• Investigators: Study Director: Suzanne McGoldrick, MD, Seagen Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2021
• Primary Completion (Actual): March 1, 2024
• Study Completion (Actual): March 1, 2024

Study Registration Dates

• First Submitted: December 7, 2020
• First Submitted That Met QC Criteria: December 7, 2020
• First Posted (Actual): December 14, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 6, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: NSCLC; Non-Small Cell Lung Cancer; Gastric Cancer; Cervical Cancer; Colorectal Cancer; Ovarian Cancer; Endometrial Cancer; Esophageal Cancer; Seattle Genetics; HGSOC; HER2-Negative Breast Cancer; High-Grade Serous Ovarian Cancer; GEJ Carcinoma
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Intestinal Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Neoplasms; Rectal Diseases; Uterine Diseases; Genital Diseases, Female; Lung Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Colonic Diseases; Esophageal Diseases; Lung Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Skin Diseases; Breast Diseases; Uterine Cervical Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Uterine Neoplasms; Neoplasms, Cystic, Mucinous, and Serous; Adenocarcinoma, Mucinous; Neoplasms; Stomach Neoplasms; Carcinoma; Colorectal Neoplasms; Esophageal Neoplasms; Ovarian Neoplasms; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Uterine Cervical Neoplasms; Adenocarcinoma; Endometrial Neoplasms; Pseudomyxoma Peritonei
• Other Study ID Numbers: SGNSTNV-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No