Breast Cancer Clinical Trial

A Study of SGN-STNV in Advanced Solid Tumors

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.

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Full 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.

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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

There are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met.

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

111

Study ID:

NCT04665921

Recruitment Status:

Active, not recruiting

Sponsor:

Seagen Inc.

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There are 17 Locations for this study

See Locations Near You

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

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

111

Study ID:

NCT04665921

Recruitment Status:

Active, not recruiting

Sponsor:


Seagen Inc.

How clear is this clinincal trial information?

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