Description:
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.
Title
- Brief Title: A Study of SGN-STNV in Advanced Solid Tumors
- Official Title: A Phase 1 Study of SGN-STNV in Advanced Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
SGNSTNV-001
- NCT ID:
NCT04665921
Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Human Epidermal Growth Factor Receptor 2 (HER2) Negative Breast Cancer
- Ovarian Cancer
- Cervical Cancer
- Endometrial Cancer
- Esophageal Cancer
- Gastric Cancer and Gastroesophageal Junction (GEJ) Carcinoma
- Colorectal Cancer
- Exocrine Pancreatic Adenocarcinoma
- Appendiceal Adenocarcinoma
- Pseudomyxoma Peritonei
Interventions
| Drug | Synonyms | Arms |
|---|
| SGN-STNV | | SGN-STNV |
Purpose
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 be
gated based on data generated from other expansion cohorts and 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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| SGN-STNV | Experimental | SGN-STNV monotherapy | |
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.
- 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
- 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
- Participants must have completed chemotherapy, immunotherapy, biologics, and/or other
approved or investigational antitumor treatment prior to the first dose of study drug.
- Participants of childbearing potential must have a negative serum or urine beta human
chorionic gonadotropin (β hCG) pregnancy test result within 7 days prior to the first
dose of SGN-STNV.
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 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.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Incidence of adverse events (AEs) |
| Time Frame: | Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years |
| Safety Issue: | |
| Description: | To be summarized using descriptive statistics |
Secondary Outcome Measures
| Measure: | Objective response rate (ORR) as assessed by the investigator per RECIST v1.1 |
| Time Frame: | Up to approximately 3 years |
| Safety Issue: | |
| Description: | ORR is defined as the proportion of subjects achieving a partial response (PR) or complete response (CR). |
| Measure: | Progression-free survival (PFS) |
| Time Frame: | Up to approximately 3 years |
| Safety Issue: | |
| Description: | 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. |
| Measure: | Overall survival (OS) |
| Time Frame: | Up to approximately 3 years |
| Safety Issue: | |
| Description: | OS is defined as the time from the start of any study treatment to the date of death due to any cause. |
| Measure: | Duration of objective response (DOR) |
| Time Frame: | Up to approximately 3 years |
| Safety Issue: | |
| Description: | 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. |
| Measure: | Area under the concentration-time curve (AUC) |
| Time Frame: | Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years |
| Safety Issue: | |
| Description: | Pharmacokinetic (PK) endpoint |
| Measure: | Time to maximum concentration (Tmax) |
| Time Frame: | Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years |
| Safety Issue: | |
| Description: | PK endpoint |
| Measure: | Maximum concentration (Cmax) |
| Time Frame: | Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years |
| Safety Issue: | |
| Description: | PK endpoint |
| Measure: | Trough concentration (Ctrough) |
| Time Frame: | Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years |
| Safety Issue: | |
| Description: | PK endpoint |
| Measure: | Incidence of antidrug antibodies (ADA) |
| Time Frame: | Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years |
| Safety Issue: | |
| Description: | Immunogenicity endpoint |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Seagen Inc. |
Trial Keywords
Last Updated
August 10, 2021
