A Study of SGN-STNV in Advanced Solid Tumors
Reason given: Study closed due to portfolio prioritization
Key facts
- Where
- Boston, Cleveland, Gainesville, Grand Rapids, Los Angeles, Miami, New York, Pittsburgh, Portland, San Antonio, and San Francisco, United StatesSee the 12 sites
- Phase
- Phase 1
Where in United States
- Beth Israel Deaconess Medical CenterBoston, United StatesNo longer taking part
- Dana-Farber Cancer InstituteBoston, United StatesNo longer taking part
- University Hospitals Cleveland Medical Center*Cleveland, United StatesNo longer taking part
- Shands Cancer Center / University of FloridaGainesville, United StatesNo longer taking part
- South Texas Accelerated Research Therapeutics MidwestGrand Rapids, United StatesNo longer taking part
- The Angeles Clinic and Research InstituteLos Angeles, United StatesNo longer taking part
- University of MiamiMiami, United StatesNo longer taking part
- Memorial Sloan-Kettering Cancer CenterNew York, United StatesNo longer taking part
- Magee-Womens Hospital of UPMCPittsburgh, United StatesNo longer taking part
- Oregon Health and Science UniversityPortland, United StatesNo longer taking part
- South Texas Accelerated Research TherapeuticsSan Antonio, United StatesNo longer taking part
- University of California, San Francisco | HDFCCC - Hematopoietic MalignanciesSan Francisco, United StatesNo longer taking part
Trial details
- Who runs it
- Seagen Inc.
- Trial code
- NCT04665921
- Record updated
- 7 February 2025
- Original description
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.Read full original descriptionShow less
A Phase 1 Study of SGN-STNV in Advanced Solid Tumors
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.
Inclusion: 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: Previous receipt of monomethylauristatin E (MMAE)-containing drugs; 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; 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; Pre-existing neuropathy ≥ Grade 2 per the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0; Known active central nervous system metastases; Carcinomatous meningitis.