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.
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.
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.
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There are 17 Locations for this study
Los Angeles California, 90025, United States
San Francisco California, 94158, United States
Gainesville Florida, 32610, United States
Miami Florida, 33136, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
Grand Rapids Michigan, 49546, United States
New York New York, 10065, United States
Cleveland Ohio, 44106, United States
Portland Oregon, 97239, United States
Pittsburgh Pennsylvania, 15213, United States
San Antonio Texas, 78229, United States
Ottawa Ontario, K1H 8, Canada
Toronto Other, M5G 2, Canada
Villejuif Cedex Other, 94805, France
Milano Other, 20132, Italy
Barcelona Other, 08035, Spain
Sutton Other, SM2 5, United Kingdom
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