Status:
TERMINATED
A Study of SGN-STNV in Advanced Solid Tumors
Lead Sponsor:
Seagen Inc.
Conditions:
Carcinoma, Non-Small Cell Lung
HER2 Negative Breast Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 th...
Detailed 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 b...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2024
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT04665921
Start Date
January 18 2021
End Date
March 1 2024
Last Update
February 7 2025
Active Locations (18)
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1
The Angeles Clinic and Research Institute
Los Angeles, California, United States, 90025
2
University of California, San Francisco | HDFCCC - Hematopoietic Malignancies
San Francisco, California, United States, 94158
3
Shands Cancer Center / University of Florida
Gainesville, Florida, United States, 32610
4
University of Miami
Miami, Florida, United States, 33136