A Study of Sigvotatug Vedotin in Advanced Solid Tumors
Recruiting · NCT04389632 · Interventional (participants receive a specific treatment) · Lead sponsor: Seagen, a wholly owned subsidiary of Pfizer
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This trial will look at a drug called sigvotatug vedotin (SGN-B6A) alone and with pembrolizumab, with or without chemotherapy, to find out whether it is safe for people who have solid tumors. It will study sigvotatug vedotin to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether sigvotatug vedotin works to treat solid tumors. The study will have four parts. * Part A of the study will find out how much sigvotatug vedotin should be given to participants. * Part B will use the dose found in Part A to find out how safe sigvotatug vedotin is and if it works to treat solid tumors. * Part C of the study will find out how safe sigvotatug vedotin is in combination with these other drugs. * Part D will include people who have not received treatment. This part of the study will find out how safe sigvotatug vedotin is in combination with these other drugs and if these combinations work to treat solid tumors. * In Parts C and D, participants will receive sigvotatug vedotin with either: * Pembrolizumab or, * Pembrolizumab and carboplatin, or * Pembrolizumab and cisplatin.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Disease indication
- Participants must have histologically or cytologically confirmed metastatic or unresectable solid malignancy within one of the tumor types listed below (dependent on study part).
- Non-small cell lung cancer (NSCLC)
- Head and neck squamous cell cancer (HNSCC)
- Advanced HER2-negative breast cancer
- Esophageal squamous cell carcinoma (ESCC)
- Esophageal/Gastro-esophageal junction adenocarcinoma (EAC/GEJ)
- Cutaneous squamous cell cancer (cSCC)
- Exocrine pancreatic adenocarcinoma
- Bladder cancer
- Cervical cancer
- Gastric cancer
- High grade serous ovarian cancer (HGSOC)
- Part A only: Participants 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 options.
- Part B only: Participants must have disease that is relapsed or refractory or be intolerant to standard-of-care therapies. Participants must have received platinum-based therapy and a PD-1/PD-(L)1 inhibitor, if applicable and available.
- Part C only: For pembrolizumab combination cohorts, participants must be eligible for pembrolizumab per local standard of care. For pembrolizumab with cisplatin or carboplatin, participants must be eligible for both pembrolizumab and the platinum agent per local standard of care. Participants must be treatment naïve for locally advanced or metastatic systemic therapy (prior definitively intended or \[neo\]adjuvant therapy is allowed).
- Part D only: Participants must be treatment naïve for locally advanced or metastatic systemic therapy.
- Participants enrolled in the following study parts should have a tumor site accessible for biopsy and agree to biopsy as follows:
- Disease-specific expansion cohorts (Part B and Part D): A baseline fresh tumor biopsy is required. An archival biopsy collected within 90 days prior to first dose of study drug may be used.
- Biology expansion cohort: pretreatment biopsy and on-treatment (Cycle 1) biopsy
- An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Measurable disease per the RECIST v1.1 at baseline
Exclusion criteria
- History of another malignancy within 3 years before first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.
- Known active central nervous system metastases. Participants with previously treated brain metastases may participate provided they:
- are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment,
- have no new or enlarging brain metastases, and
- are off of corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to first dose of study drug.
- In Part D, participants with untreated, asymptomatic CNS metastases smaller than 1 cm may be enrolled without definitive treatment as long as they have no neurological symptoms, no or minimal surrounding edema, and no requirements for corticosteroids.
- Carcinomatous meningitis
- Previous receipt of an MMAE-containing agent or an agent targeting integrin beta-6
- Pre-existing neuropathy Grade 1 or greater per the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0) for Parts C and D cohorts with cisplatin or carboplatin; Grade 2 or greater per the NCI CTCAE v5.0 for all other cohorts
- Any uncontrolled Grade 3 or higher (per NCI CTCAE v5.0) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of sigvotatug vedotin.
- Routine antimicrobial prophylaxis is permitted
- Grade ≥3 pulmonary disease unrelated to underlying malignancy. This includes clinically severe pulmonary function compromise resulting from clinically significant pulmonary illnesses
- Part C and D: Prior therapy with a PD-1 inhibitor, anti-PD-(L)1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and was discontinued from that treatment due to a Grade 3 or higher immune-mediated adverse event (IMAE).
- History of noninfectious interstitial lung disease (ILD) or pneumonitis that required steroids, current ILD or pneumonitis, or suspected ILD or pneumonitis that cannot be ruled out by imaging at screening
- Known diffusing capacity of the lung for carbon monoxide (DLCO; adjusted for hemoglobin) \<50% predicted
- Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
Where it is running
60 locations listed across 19 US states.
- Alaska Oncology and Hematology - Anchorage, Alaska, United States
- Highlands Oncology Group - Fayetteville, Arkansas, United States
- Highlands Oncology Group - Rogers, Arkansas, United States
- Highlands Oncology Group - Springdale, Arkansas, United States
- Providence Medical Foundation - Anaheim, California, United States
- Providence Medical Foundation - Fullerton, California, United States
- Providence St. Jude Medical Center Virginia K Crosson and Infusion Center - Fullerton, California, United States
- Cancer and Blood Research Center, LLC - Los Alamitos, California, United States
- Cancer and Blood Specialty Clinic - Los Alamitos, California, United States
- Ronald Reagan UCLA Medical Center - Los Angeles, California, United States
- The Regents of the University of California - Los Angeles, California, United States
- UCLA Department of Medicine-Hematology/Oncology - Los Angeles, California, United States
- UCLA Department of Medicine - Hematology & Oncology - Santa Monica, California, United States
- Cancer AND Blood Specialty Clinic - Torrance, California, United States
- American Oncology Partners, PA. a Florida professional service corporation, d/b/a Vista Oncology - Fort Myers, Florida, United States
- Florida Cancer Specialists & Research Institute, LLC - Fort Myers, Florida, United States
- Memorial Cancer Institute - Hollywood, Florida, United States
- Memorial Healthcare System - Hollywood, Florida, United States
- Florida Cancer Specialists - Orlando, Florida, United States
- Memorial Cancer Institute at Memorial Hospital West - Pembroke Pines, Florida, United States
- Memorial Hospital West - Pembroke Pines, Florida, United States
- Ingalls Family Care Center - Calumet City, Illinois, United States
- UChicago Medicine - River East - Chicago, Illinois, United States
- The University Of Chicago - Chicago, Illinois, United States
- University of Chicago Medical Center - Chicago, Illinois, United States
- UChicago Medicine at Ingalls - Flossmoor - Flossmoor, Illinois, United States
- UChicago Medicine Ingalls Memorial - Harvey, Illinois, United States
- University of Chicago Comprehensive Cancer Center at Silver Cross Hospital - New Lenox, Illinois, United States
- The University of Chicago Medicine Center for Advanced Care Orland Park - Orland Park, Illinois, United States
- Southern Illinois University - Simmons Cancer Institute - Springfield, Illinois, United States
- Springfield Clinic Radiology - 800 Building - Springfield, Illinois, United States
- Springfield Clinic Urgent Care Plus - Springfield, Illinois, United States
- Springfield Clinic - Springfield, Illinois, United States
- Springfield Clinic Main Campus - Springfield, Illinois, United States
- Springfield Clinic Radiology - Main Campus - Springfield, Illinois, United States
- Springfield Memorial Hospital - Springfield, Illinois, United States
- UChicago Medicine at Ingalls - Tinley Park - Tinley Park, Illinois, United States
- UChicago Medicine - Northwest Indiana - Crown Point, Indiana, United States
- Fort Wayne Medical Oncology and Hematology, Inc - Fort Wayne, Indiana, United States
- Community Health Network, Inc - Indianapolis, Indiana, United States
- Community Health Network, Inc. - Indianapolis, Indiana, United States
- Community Health Network Investigational Drug Services - Indianapolis, Indiana, United States
- Community Health Network, Inc. - Indianapolis, Indiana, United States
- The University of Kansas Cancer Center, Investigational Drug Services - Fairway, Kansas, United States
- The University of Kansas Clinical Research Center - Fairway, Kansas, United States
- The University of Kansas Hospital - Kansas City, Kansas, United States
- The University of Kansas Medical Center Medical Office Building - Kansas City, Kansas, United States
- University of Kansas Hospital Cambridge North Tower A - Kansas City, Kansas, United States
- University of Kansas Medical Center Research Institute - Kansas City, Kansas, United States
- The University of Kansas Cancer Center - Indian Creek Campus - Overland Park, Kansas, United States
- The University of Kansas Cancer Center - Westwood - Westwood, Kansas, United States
- University of Kansas Cancer Center - Westwood, Kansas, United States
- Massachusetts General Hospital - Boston, Massachusetts, United States
- Brigham & Women's Hospital - Boston, Massachusetts, United States
- Beth Israel Deaconess Medical Center,East Campus Research Pharmacy - Boston, Massachusetts, United States
- Beth Israel Deaconess Medical Center - Boston, Massachusetts, United States
- Dana Farber Cancer Institute - Boston, Massachusetts, United States
- Dana-Farber Cancer Institute - Chestnut Hill - Newton, Massachusetts, United States
- Allina Health Cancer Institute - Mercy Hospital - Coon Rapids, Minnesota, United States
- Allina Health Cancer Institute - Abbott Northwestern Hospital - Minneapolis, Minnesota, United States
Showing 60 of 158 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →