A Study of SGN-STNV in Advanced Solid Tumors

March 15, 2024 updated by: Seagen Inc.

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

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • University of Ottawa / Ottawa General Hospital
    • Other
      • Toronto, Other, Canada, M5G 2C1
        • University Health Network, Princess Margaret Hospital
    • Other
      • Villejuif Cedex, Other, France, 94805
        • Institut Gustave Roussy
    • Other
      • Milano, Other, Italy, 20132
        • Istituto Europeo di Oncologia
    • Other
      • Barcelona, Other, Spain, 08035
        • Hospital Universitari Vall d'Hebron
    • Other
      • Sutton, Other, United Kingdom, SM2 5PT
        • The Royal Marsden Hospital (Surrey)
    • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: SGN-STNV
SGN-STNV monotherapy
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)
Time Frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
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
Time Frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
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
Time Frame: Up to 28 days
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
Time Frame: Up to approximately 3 years
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)
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.
Up to approximately 3 years
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.
Up to approximately 3 years
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.
Up to approximately 3 years
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
Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
Time to maximum concentration (Tmax)
Time Frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
PK endpoint
Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
Maximum concentration (Cmax)
Time Frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
PK endpoint
Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
Trough concentration (Ctrough)
Time Frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
PK endpoint
Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
Incidence of antidrug antibodies (ADA)
Time Frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
Immunogenicity endpoint
Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 19, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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