A Study of SGN-STNV in Advanced Solid Tumors

NCT ID: NCT04665921

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-18
• Study Completion Date: 2024-03-01

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.

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SGN-STNV

SGN-STNV monotherapy

Group Type: EXPERIMENTAL

SGN-STNV

Intervention Type: DRUG

Given into the vein (IV; intravenously)

Interventions

SGN-STNV

Given into the vein (IV; intravenously)

Intervention Type: DRUG

Eligibility 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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seagen Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suzanne McGoldrick, MD

Role: STUDY_DIRECTOR

Seagen Inc.

Locations

The Angeles Clinic and Research Institute

Los Angeles, California, United States

University of California, San Francisco | HDFCCC - Hematopoietic Malignancies

San Francisco, California, United States

Shands Cancer Center / University of Florida

Gainesville, Florida, United States

University of Miami

Miami, Florida, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

South Texas Accelerated Research Therapeutics Midwest

Grand Rapids, Michigan, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Oregon Health and Science University

Portland, Oregon, United States

Magee Womens Hospital of UPMC

Pittsburgh, Pennsylvania, United States

South Texas Accelerated Research Therapeutics

San Antonio, Texas, United States

University of Ottawa / Ottawa General Hospital

Ottawa, Ontario, Canada

University Health Network, Princess Margaret Hospital

Toronto, Other, Canada

Institut Gustave Roussy

Villejuif, Other, France

Istituto Europeo di Oncologia

Milan, Other, Italy

Hospital Universitari Vall d'Hebron

Barcelona, Other, Spain

The Royal Marsden Hospital (Surrey)

Sutton, Other, United Kingdom

Countries

United States; Canada; France; Italy; Spain; United Kingdom

Other Identifiers

SGNSTNV-001

Identifier Type: -

Identifier Source: org_study_id