A Study of Sigvotatug Vedotin in Advanced Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
sigvotatug vedotin: Administered into the vein (IV; intravenously)
pembrolizumab: 200mg every 3 weeks or 400mg every 6 weeks, given by IV
cisplatin: 75 mg/m2 every 3 weeks, given by IV
carboplatin: AUC 5 mg/mL per min every 3 weeks, given by IV
Study summary
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.
Eligibility
Primary outcome measure(s)
- Number of participants with adverse events (AEs) — Through 30-37 days following last dose of sigvotatug vedotin. For participants receiving pembrolizumab up to 90 days after last dose of pembrolizumab; up to 3 years
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. - Number of patients with laboratory abnormalities — Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
- Number of participants with dose-limiting toxicities (DLTs) — Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Trial sites (158)
| Facility | City | Region | Status |
|---|---|---|---|
| Alaska Oncology and Hematology | Anchorage | Alaska | Recruiting |
| Highlands Oncology Group | Fayetteville | Arkansas | Recruiting |
| Highlands Oncology Group | Rogers | Arkansas | Recruiting |
| Highlands Oncology Group | Springdale | Arkansas | Recruiting |
| Providence Medical Foundation | Anaheim | California | Recruiting |
| Providence Medical Foundation | Fullerton | California | Recruiting |
| Providence St. Jude Medical Center Virginia K Crosson and Infusion Center | Fullerton | California | Recruiting |
| Cancer and Blood Research Center, LLC | Los Alamitos | California | Not Yet Recruiting |
| Cancer and Blood Specialty Clinic | Los Alamitos | California | Not Yet Recruiting |
| Ronald Reagan UCLA Medical Center | Los Angeles | California | Recruiting |
| The Regents of the University of California | Los Angeles | California | Recruiting |
| UCLA Department of Medicine-Hematology/Oncology | Los Angeles | California | Recruiting |
| UCLA Department of Medicine - Hematology & Oncology | Santa Monica | California | Recruiting |
| Cancer AND Blood Specialty Clinic | Torrance | California | Not Yet Recruiting |
| American Oncology Partners, PA. a Florida professional service corporation, d/b/a Vista Oncology | Fort Myers | Florida | Recruiting |
| Florida Cancer Specialists & Research Institute, LLC | Fort Myers | Florida | Recruiting |
| Memorial Cancer Institute | Hollywood | Florida | Recruiting |
| Memorial Healthcare System | Hollywood | Florida | Recruiting |
| Florida Cancer Specialists | Orlando | Florida | Recruiting |
| Memorial Cancer Institute at Memorial Hospital West | Pembroke Pines | Florida | Recruiting |
| Memorial Hospital West | Pembroke Pines | Florida | Recruiting |
| Ingalls Family Care Center | Calumet City | Illinois | Recruiting |
| UChicago Medicine - River East | Chicago | Illinois | Recruiting |
| The University Of Chicago | Chicago | Illinois | Recruiting |
| University of Chicago Medical Center | Chicago | Illinois | Recruiting |
| UChicago Medicine at Ingalls - Flossmoor | Flossmoor | Illinois | Recruiting |
| UChicago Medicine Ingalls Memorial | Harvey | Illinois | Recruiting |
| University of Chicago Comprehensive Cancer Center at Silver Cross Hospital | New Lenox | Illinois | Recruiting |
| The University of Chicago Medicine Center for Advanced Care Orland Park | Orland Park | Illinois | Recruiting |
| Southern Illinois University - Simmons Cancer Institute | Springfield | Illinois | Recruiting |
| Springfield Clinic Radiology - 800 Building | Springfield | Illinois | Recruiting |
| Springfield Clinic Urgent Care Plus | Springfield | Illinois | Recruiting |
| Springfield Clinic | Springfield | Illinois | Recruiting |
| Springfield Clinic Main Campus | Springfield | Illinois | Recruiting |
| Springfield Clinic Radiology - Main Campus | Springfield | Illinois | Recruiting |
| Springfield Memorial Hospital | Springfield | Illinois | Recruiting |
| UChicago Medicine at Ingalls - Tinley Park | Tinley Park | Illinois | Recruiting |
| UChicago Medicine - Northwest Indiana | Crown Point | Indiana | Recruiting |
| Fort Wayne Medical Oncology and Hematology, Inc | Fort Wayne | Indiana | Recruiting |
| Community Health Network, Inc | Indianapolis | Indiana | Recruiting |
+ 118 more sites — see the full list on the official registry below.
On this site
📄 Keytruda (pembrolizumab) drug profile →More Seagen, a wholly owned subsidiary of Pfizer trials in Switzerland
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04389632 on ClinicalTrials.gov ↗ ← All trials in Switzerland