A Study of SGN-STNV in Advanced Solid Tumors
- Conditions
- Ovarian NeoplasmsPseudomyxoma PeritoneiUterine Cervical NeoplasmsGastroesophageal Junction CarcinomaStomach NeoplasmsAppendiceal AdenocarcinomaEsophageal NeoplasmsExocrine Pancreatic AdenocarcinomaCarcinoma, Non-Small Cell LungHER2 Negative Breast Neoplasms
- Interventions
- Registration Number
- NCT04665921
- Lead Sponsor
- Seagen Inc.
- 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 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.
- 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 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 111
-
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)
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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)
-
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Measurable disease per the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) at baseline
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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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SGN-STNV SGN-STNV SGN-STNV monotherapy
- Primary Outcome Measures
Name Time Method Incidence of adverse events (AEs) Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years To be summarized using descriptive statistics
Incidence of laboratory abnormalities Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years To be summarized using descriptive statistics
Incidence of dose limiting toxicities Up to 28 days To be summarized using descriptive statistics
- Secondary Outcome Measures
Name Time Method Objective response rate (ORR) as assessed by the investigator per RECIST v1.1 Up to approximately 3 years ORR is defined as the proportion of subjects achieving a partial response (PR) or complete response (CR).
Area under the concentration-time curve (AUC) Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years Pharmacokinetic (PK) endpoint
Progression-free survival (PFS) Up to approximately 3 years PFS is defined as the time from the start of any study treatment to first documentation of disease progression or to death due to any cause, whichever comes first.
Overall survival (OS) Up to approximately 3 years OS is defined as the time from the start of any study treatment to the date of death due to any cause.
Duration of objective response (DOR) Up to approximately 3 years DOR is defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression or to death due to any cause, whichever comes first.
Time to maximum concentration (Tmax) Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years PK endpoint
Incidence of antidrug antibodies (ADA) Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years Immunogenicity endpoint
Maximum concentration (Cmax) Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years PK endpoint
Trough concentration (Ctrough) Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years PK endpoint
Trial Locations
- Locations (18)
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
The Angeles Clinic and Research Institute
🇺🇸Los Angeles, California, United States
University of California, San Francisco | HDFCCC - Hematopoietic Malignancies
🇺🇸San Francisco, California, United States
Shands Cancer Center / University of Florida
🇺🇸Gainesville, Florida, United States
University of Miami
🇺🇸Miami, Florida, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Magee Womens Hospital of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
South Texas Accelerated Research Therapeutics
🇺🇸San Antonio, Texas, United States
University of Ottawa / Ottawa General Hospital
🇨🇦Ottawa, Ontario, Canada
University Health Network, Princess Margaret Hospital
🇨🇦Toronto, Other, Canada
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Other, Spain
The Royal Marsden Hospital (Surrey)
🇬🇧Sutton, Other, United Kingdom
Istituto Europeo di Oncologia
🇮🇹Milano, Other, Italy
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
South Texas Accelerated Research Therapeutics Midwest
🇺🇸Grand Rapids, Michigan, United States
Institut Gustave Roussy
🇫🇷Villejuif Cedex, Other, France