A Study of SGN-STNV in Advanced Solid Tumours
Research type
Research Study
Full title
A Phase 1 Study of SGN-STNV in Advanced Solid Tumors
IRAS ID
295691
Contact name
Anna Minchom
Contact email
Sponsor organisation
Seagen Inc.
Eudract number
2020-004340-29
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
2 years, 5 months, 27 days
Research summary
This study is being carried out to test if SGN-STNV (investigational drug) is safe and effective for the treatment of advanced cancer.
SGN-STNV is a type of drug called an antibody-drug conjugate (ADC); ADCs usually have 2 parts - antibody and drug.
Antibodies are part of our immune system to help protect against infection and the drug component are designed to target specific cancer cells so that the drug part can be absorbed into the cancer cells causing cell death.
We are asking patients who have one of the following types of cancers to participate in this study: 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 and pseudomyxoma peritonei of unknown origin.
This is a Phase 1, first time in human, open-label, multicenter, dose-escalation, and dose-expansion study designed to evaluate the safety, tolerability, pharmacokinetics, and antitumour activity of SGN-STNV in adults with select advanced solid tumours. 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. Up to approximately 205 patients may be enrolled in this study.PART A (Dose-Escalation Cohorts): The dose-escalation portion of this trial (Part A) will be conducted in up to approximately 25 patients to evaluate the safety, tolerability, and pharmacokinetics of SGN-STNV, and to identify the Maximum Tolerated Dose (Maximum tolerated dose is the highest dose of a drug or treatment that does not cause unacceptable side effects) and/or recommended dose. If the Maximum Tolerated Dose (MTD) is not reached, safety, pharmacokinetics, pharmacodynamics, and biomarker analyses, as well as preliminary antitumour activity, may be used to determine a recommended dose and schedule.
Part B (Dose-Expansion Cohorts): To further characterize the safety, tolerability, pharmacokinetics and antitumour activity of SGN-STNV, up to approximately 180 additional patients may be enrolled in expansion cohorts. Expansion cohorts will enroll patients with selected tumour types that are eligible for enrollment in dose-escalation. The dose(s), schedule, and disease setting for expansion cohorts will be determined by the sponsor in consultation with the Safety Monitoring Committee and may differ between cohorts.
For all patients, the most recently collected archival tumour biopsy is requested if available. If a tumour sample is obtained as part of standard of care during the study, with the patient’s consent, a part of that sample should be submitted to the sponsor for biomarker testing.
For certain patients in the Expansion and Biology cohorts; Newly obtained biopsy will be performed within 28 days prior to initial dose and additional on-treatment at Cycle 1- Day 15 for biology cohort patients only.REC name
London - Central Research Ethics Committee
REC reference
21/LO/0331
Date of REC Opinion
19 May 2021
REC opinion
Further Information Favourable Opinion