A Study of SGN-STNV in Advanced Solid Tumors
Carcinoma, Non-Small Cell Lung, HER2 Negative Breast Neoplasms, Ovarian Neoplasms
About this trial
This is an interventional treatment trial for Carcinoma, Non-Small Cell Lung focused on measuring NSCLC, Non-Small Cell Lung Cancer, HER2-Negative Breast Cancer, High-Grade Serous Ovarian Cancer, HGSOC, Ovarian Cancer, Cervical Cancer, Endometrial Cancer, Esophageal Cancer, Gastric Cancer, GEJ Carcinoma, Colorectal Cancer, Seattle Genetics
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.
Sites / Locations
- The Angeles Clinic and Research Institute
- University of California at San Francisco
- Shands Cancer Center / University of Florida
- University of Miami
- Beth Israel Deaconess Medical Center
- Dana Farber Cancer Institute
- South Texas Accelerated Research Therapeutics Midwest
- Memorial Sloan Kettering Cancer Center
- University Hospitals Cleveland Medical Center
- Oregon Health and Science University
- Magee Womens Hospital of UPMC
- South Texas Accelerated Research Therapeutics
- University of Ottawa / Ottawa General Hospital
- University Health Network, Princess Margaret Hospital
- Institut Gustave Roussy
- Istituto Europeo di Oncologia
- Hospital Universitari Vall d'Hebron
- The Royal Marsden Hospital (Surrey)
Arms of the Study
Arm 1
Experimental
SGN-STNV
SGN-STNV monotherapy