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 a tumor site accessible for biopsy and agree to biopsy as follows:
Disease-specific expansion cohorts: pre-treatment biopsy
Biology expansion cohort: pretreatment biopsy and additional on-treatment biopsy during Cycle 1
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 More Info
Principal Investigator
San Francisco California, 94158, United States More Info
Principal Investigator
Gainesville Florida, 32610, United States More Info
Principal Investigator
Miami Florida, 33136, United States More Info
Principal Investigator
Boston Massachusetts, 02215, United States More Info
Principal Investigator
Boston Massachusetts, 02215, United States More Info
Principal Investigator
Grand Rapids Michigan, 49546, United States More Info
Principal Investigator
New York New York, 10065, United States More Info
Principal Investigator
Cleveland Ohio, 44106, United States More Info
Principal Investigator
Portland Oregon, 97239, United States More Info
Principal Investigator
Pittsburgh Pennsylvania, 15213, United States More Info
Principal Investigator
San Antonio Texas, 78229, United States More Info
Principal Investigator
Ottawa Ontario, K1H 8, Canada More Info
Principal Investigator
Toronto Other, M5G 2, Canada More Info
Principal Investigator
Villejuif Cedex Other, 94805, France More Info
Principal Investigator
Milan Other, 20141, Italy More Info
Principal Investigator
Barcelona Other, 08035, Spain More Info
Principal Investigator
Sutton Other, SM2 5, United Kingdom More Info
Principal Investigator
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