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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04665921
Other study ID # SGNSTNV-001
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
Start date January 18, 2021
Est. completion date March 1, 2024

Study information

Verified date March 2024
Source Seagen Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

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.

Study Design


Intervention

Drug:
SGN-STNV
Given into the vein (IV; intravenously)

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Seagen Inc.

Countries where clinical trial is conducted

United States,  Canada,  France,  Italy,  Spain,  United Kingdom, 

Outcome

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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