A Study of SGN-STNV in Advanced Solid Tumors
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ClinicalTrials.gov Identifier: NCT04665921 |
Recruitment Status :
Terminated
(Study closed due to portfolio prioritization)
First Posted : December 14, 2020
Last Update Posted : March 19, 2024
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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.
Condition or disease | Intervention/treatment | Phase |
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Carcinoma, Non-Small Cell Lung HER2 Negative Breast Neoplasms Ovarian Neoplasms Uterine Cervical Neoplasms Endometrial Neoplasms Esophageal Neoplasms Gastroesophageal Junction Carcinoma Stomach Neoplasms Colorectal Neoplasms Exocrine Pancreatic Adenocarcinoma Appendiceal Adenocarcinoma Pseudomyxoma Peritonei | Drug: SGN-STNV | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 111 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1 Study of SGN-STNV in Advanced Solid Tumors |
Actual Study Start Date : | January 18, 2021 |
Actual Primary Completion Date : | March 1, 2024 |
Actual Study Completion Date : | March 1, 2024 |
Arm | Intervention/treatment |
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Experimental: SGN-STNV
SGN-STNV monotherapy
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Drug: SGN-STNV
Given into the vein (IV; intravenously) |
- 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
- Objective response rate (ORR) as assessed by the investigator per RECIST v1.1 [ Time Frame: Up to approximately 3 years ]ORR is defined as the proportion of subjects achieving a partial response (PR) or complete response (CR).
- Progression-free survival (PFS) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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.
- Area under the concentration-time curve (AUC) [ Time Frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years ]Pharmacokinetic (PK) endpoint
- Time to maximum concentration (Tmax) [ Time Frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years ]PK endpoint
- Maximum concentration (Cmax) [ Time Frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years ]PK endpoint
- Trough concentration (Ctrough) [ Time Frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years ]PK endpoint
- Incidence of antidrug antibodies (ADA) [ Time Frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years ]Immunogenicity endpoint
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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Disease indication
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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
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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
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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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04665921
Study Director: | Suzanne McGoldrick, MD | Seagen Inc. |
Responsible Party: | Seagen Inc. |
ClinicalTrials.gov Identifier: | NCT04665921 |
Other Study ID Numbers: |
SGNSTNV-001 |
First Posted: | December 14, 2020 Key Record Dates |
Last Update Posted: | March 19, 2024 |
Last Verified: | March 2024 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
NSCLC Non-Small Cell Lung Cancer HER2-Negative Breast Cancer High-Grade Serous Ovarian Cancer HGSOC Ovarian Cancer Cervical Cancer |
Endometrial Cancer Esophageal Cancer Gastric Cancer GEJ Carcinoma Colorectal Cancer Seattle Genetics |
Carcinoma Neoplasms Adenocarcinoma Breast Neoplasms Colorectal Neoplasms Carcinoma, Non-Small-Cell Lung Ovarian Neoplasms Stomach Neoplasms Esophageal Neoplasms Uterine Cervical Neoplasms Endometrial Neoplasms Pseudomyxoma Peritonei Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms by Site |
Breast Diseases Skin Diseases Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms |