Colorectal Neoplasms Clinical Trial
Official title:
A Phase 1 Study of SGN-STNV in Advanced Solid Tumors
Verified date | March 2024 |
Source | Seagen Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 111 |
Est. completion date | March 1, 2024 |
Est. primary completion date | March 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | University of Ottawa / Ottawa General Hospital | Ottawa | Ontario |
Canada | University Health Network, Princess Margaret Hospital | Toronto | Other |
France | Institut Gustave Roussy | Villejuif Cedex | Other |
Italy | Istituto Europeo di Oncologia | Milano | Other |
Spain | Hospital Universitari Vall d'Hebron | Barcelona | Other |
United Kingdom | The Royal Marsden Hospital (Surrey) | Sutton | Other |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
United States | University Hospitals Cleveland Medical Center | Cleveland | Ohio |
United States | Shands Cancer Center / University of Florida | Gainesville | Florida |
United States | South Texas Accelerated Research Therapeutics Midwest | Grand Rapids | Michigan |
United States | The Angeles Clinic and Research Institute | Los Angeles | California |
United States | University of Miami | Miami | Florida |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
United States | Magee Womens Hospital of UPMC | Pittsburgh | Pennsylvania |
United States | Oregon Health and Science University | Portland | Oregon |
United States | South Texas Accelerated Research Therapeutics | San Antonio | Texas |
United States | University of California, San Francisco | HDFCCC - Hematopoietic Malignancies | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Seagen Inc. |
United States, Canada, France, Italy, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of adverse events (AEs) | To be summarized using descriptive statistics | Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years | |
Primary | Incidence of laboratory abnormalities | To be summarized using descriptive statistics | Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years | |
Primary | Incidence of dose limiting toxicities | To be summarized using descriptive statistics | Up to 28 days | |
Secondary | Objective response rate (ORR) as assessed by the investigator per RECIST v1.1 | ORR is defined as the proportion of subjects achieving a partial response (PR) or complete response (CR). | Up to approximately 3 years | |
Secondary | Progression-free survival (PFS) | 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. | Up to approximately 3 years | |
Secondary | Overall survival (OS) | OS is defined as the time from the start of any study treatment to the date of death due to any cause. | Up to approximately 3 years | |
Secondary | Duration of objective response (DOR) | 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. | Up to approximately 3 years | |
Secondary | Area under the concentration-time curve (AUC) | Pharmacokinetic (PK) endpoint | Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years | |
Secondary | Time to maximum concentration (Tmax) | PK endpoint | Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years | |
Secondary | Maximum concentration (Cmax) | PK endpoint | Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years | |
Secondary | Trough concentration (Ctrough) | PK endpoint | Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years | |
Secondary | Incidence of antidrug antibodies (ADA) | Immunogenicity endpoint | Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years |
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