A Phase 1 Study of SGN-STNV in Advanced Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- SGN-STNV
- Conditions
- Carcinoma, Non-Small Cell Lung
- Sponsor
- Seagen Inc.
- Enrollment
- 111
- Locations
- 18
- Primary Endpoint
- Incidence of adverse events (AEs)
- Status
- Terminated
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- Not provided
Arms & Interventions
SGN-STNV
SGN-STNV monotherapy
Intervention: SGN-STNV
Outcomes
Primary Outcomes
Incidence of adverse events (AEs)
Time Frame: 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
Time Frame: 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
Time Frame: Up to 28 days
To be summarized using descriptive statistics
Secondary Outcomes
- Objective response rate (ORR) as assessed by the investigator per RECIST v1.1(Up to approximately 3 years)
- Area under the concentration-time curve (AUC)(Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years)
- Progression-free survival (PFS)(Up to approximately 3 years)
- Overall survival (OS)(Up to approximately 3 years)
- Duration of objective response (DOR)(Up to approximately 3 years)
- Time to maximum concentration (Tmax)(Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years)
- Incidence of antidrug antibodies (ADA)(Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years)
- Maximum concentration (Cmax)(Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years)
- Trough concentration (Ctrough)(Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years)