A Study of Sigvotatug Vedotin in Advanced Solid Tumors
A Phase 1 Study of Sigvotatug Vedotin in Advanced Solid Tumors
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
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.
Study sites (106)
AK
- Alaska Oncology and Hematology · Anchorage, AK 99508More trials in Anchorage
AR
- Highlands Oncology Group · Fayetteville, AR 72703More trials in Fayetteville
- Highlands Oncology Group · Rogers, AR 72758More trials in Rogers
- Highlands Oncology Group · Springdale, AR 72762More trials in Springdale
CA
- Providence Medical Foundation · Anaheim, CA 92805More trials in Anaheim
- Providence Medical Foundation · Fullerton, CA 92835More trials in Fullerton
- Providence St. Jude Medical Center Virginia K Crosson and Infusion Center · Fullerton, CA 92835More trials in Fullerton
- Cancer and Blood Research Center, LLC · Los Alamitos, CA 90720More trials in Los Alamitos
- Cancer and Blood Specialty Clinic · Los Alamitos, CA 90720More trials in Los Alamitos
- Ronald Reagan UCLA Medical Center · Los Angeles, CA 90095More trials in Los Angeles
- The Regents of the University of California · Los Angeles, CA 90095More trials in Los Angeles
- UCLA Department of Medicine-Hematology/Oncology · Los Angeles, CA 90095More trials in Los Angeles
- UCLA Department of Medicine - Hematology & Oncology · Santa Monica, CA 90404More trials in Santa Monica
- Cancer AND Blood Specialty Clinic · Torrance, CA 90505More trials in Torrance
FL
- American Oncology Partners, PA. a Florida professional service corporation, d/b/a Vista Oncology · Fort Myers, FL 33913More trials in Fort Myers
- Florida Cancer Specialists & Research Institute, LLC · Fort Myers, FL 33916More trials in Fort Myers
- Memorial Cancer Institute · Hollywood, FL 33021More trials in Hollywood
- Memorial Healthcare System · Hollywood, FL 33021More trials in Hollywood
- Florida Cancer Specialists · Orlando, FL 32827More trials in Orlando
- Memorial Cancer Institute at Memorial Hospital West · Pembroke Pines, FL 33028More trials in Pembroke Pines
- Memorial Hospital West · Pembroke Pines, FL 33028More trials in Pembroke Pines
IL
- Ingalls Family Care Center · Calumet City, IL 60409More trials in Calumet City
- UChicago Medicine - River East · Chicago, IL 60611More trials in Chicago
- The University Of Chicago · Chicago, IL 60637More trials in Chicago
- University of Chicago Medical Center · Chicago, IL 60637More trials in Chicago
- UChicago Medicine at Ingalls - Flossmoor · Flossmoor, IL 60422More trials in Flossmoor
- UChicago Medicine Ingalls Memorial · Harvey, IL 60426More trials in Harvey
- University of Chicago Comprehensive Cancer Center at Silver Cross Hospital · New Lenox, IL 60451More trials in New Lenox
- The University of Chicago Medicine Center for Advanced Care Orland Park · Orland Park, IL 60462More trials in Orland Park
- Southern Illinois University - Simmons Cancer Institute · Springfield, IL 62702More trials in Springfield
- Springfield Clinic Radiology - 800 Building · Springfield, IL 62702More trials in Springfield
- Springfield Clinic Urgent Care Plus · Springfield, IL 62702More trials in Springfield
- Springfield Clinic · Springfield, IL 62702More trials in Springfield
- Springfield Clinic Main Campus · Springfield, IL 62703More trials in Springfield
- Springfield Clinic Radiology - Main Campus · Springfield, IL 62703More trials in Springfield
- Springfield Memorial Hospital · Springfield, IL 62781More trials in Springfield
- UChicago Medicine at Ingalls - Tinley Park · Tinley Park, IL 60477More trials in Tinley Park
IN
- UChicago Medicine - Northwest Indiana · Crown Point, IN 46307More trials in Crown Point
- Fort Wayne Medical Oncology and Hematology, Inc · Fort Wayne, IN 46804More trials in Fort Wayne
- Community Health Network, Inc · Indianapolis, IN 46219More trials in Indianapolis
- Community Health Network, Inc. · Indianapolis, IN 46227More trials in Indianapolis
- Community Health Network Investigational Drug Services · Indianapolis, IN 46250More trials in Indianapolis
- Community Health Network, Inc. · Indianapolis, IN 46250More trials in Indianapolis
KS
- The University of Kansas Cancer Center, Investigational Drug Services · Fairway, KS 66205More trials in Fairway
- The University of Kansas Clinical Research Center · Fairway, KS 66205More trials in Fairway
- The University of Kansas Hospital · Kansas City, KS 66160More trials in Kansas City
- The University of Kansas Medical Center Medical Office Building · Kansas City, KS 66160More trials in Kansas City
- University of Kansas Hospital Cambridge North Tower A · Kansas City, KS 66160More trials in Kansas City
- University of Kansas Medical Center Research Institute · Kansas City, KS 66160More trials in Kansas City
- The University of Kansas Cancer Center - Indian Creek Campus · Overland Park, KS 66211More trials in Overland Park
- The University of Kansas Cancer Center - Westwood · Westwood, KS 66205More trials in Westwood
- University of Kansas Cancer Center · Westwood, KS 66205More trials in Westwood
MA
- Massachusetts General Hospital · Boston, MA 02114More trials in Boston
- Brigham & Women's Hospital · Boston, MA 02115More trials in Boston
- Beth Israel Deaconess Medical Center,East Campus Research Pharmacy · Boston, MA 02215More trials in Boston
- Beth Israel Deaconess Medical Center · Boston, MA 02215More trials in Boston
- Dana Farber Cancer Institute · Boston, MA 02215More trials in Boston
- Dana-Farber Cancer Institute - Chestnut Hill · Newton, MA 02467More trials in Newton
MN
- Allina Health Cancer Institute - Mercy Hospital · Coon Rapids, MN 55433More trials in Coon Rapids
- Allina Health Cancer Institute - Abbott Northwestern Hospital · Minneapolis, MN 55407More trials in Minneapolis
- Allina Health Cancer Institute - United Hospital · Saint Paul, MN 55102More trials in Saint Paul
- Allina Health Cancer Institute · Saint Paul, MN 55102More trials in Saint Paul
NV
- Comprehensive Cancer Centers of Nevada · Las Vegas, NV 89169More trials in Las Vegas
NY
- North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists · Babylon, NY 11702More trials in Babylon
- North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists · Brooklyn, NY 11210More trials in Brooklyn
- North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists · New Hyde Park, NY 11042More trials in New Hyde Park
- North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists · New York, NY 10028More trials in New York
- Columbia University Irving Medical Center · New York, NY 10032More trials in New York
- North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists · Patchogue, NY 11772More trials in Patchogue
- North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists · Port Jefferson Station, NY 11776More trials in Port Jefferson Station
- North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists · Riverhead, NY 11901More trials in Riverhead
- North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists · Shirley, NY 11967More trials in Shirley
- North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists · The Bronx, NY 10469More trials in The Bronx
OH
- University Hospitals Cleveland Medical Center · Cleveland, OH 44106More trials in Cleveland
OK
- OU Health University of Oklahoma Medical Center · Oklahoma City, OK 73104More trials in Oklahoma City
- Stephenson Cancer Center (chemo location) · Oklahoma City, OK 73104More trials in Oklahoma City
- University of Oklahoma Health Science Center · Oklahoma City, OK 73104More trials in Oklahoma City
OR
- Providence Cancer Institute Franz Clinic · Portland, OR 97213More trials in Portland
- Providence Oncology and Hematology Care Clinic - Westside · Portland, OR 97225More trials in Portland
- Providence St. Vincent Medical Center- Investigational Drug Services · Portland, OR 97225More trials in Portland
- Providence St. Vincent Medical Center · Portland, OR 97225More trials in Portland
SD
- Sanford Cancer Center · Sioux Falls, SD 57104More trials in Sioux Falls
- Sanford USD Medical Center · Sioux Falls, SD 57105More trials in Sioux Falls
TN
- US Oncology Research LLC · Nashville, TN 37203More trials in Nashville
TX
- Oncology Consultants, PA · Houston, TX 77024More trials in Houston
- Oncology Consultants, PA. · Houston, TX 77030More trials in Houston
- The University of Texas M.D. Anderson Cancer Center · Houston, TX 77030More trials in Houston
- US Oncology Investigational Product Center (IPC) · Irving, TX 75063More trials in Irving
- Houston Medical Imaging · Pearland, TX 77581More trials in Pearland
- South Texas Accelerated Research Therapeutics, LLC · San Antonio, TX 78229More trials in San Antonio
- UT Health East Texas HOPE Cancer Center · Tyler, TX 75701More trials in Tyler
- UT Health East Texas Hope Cancer Center · Tyler, TX 75708More trials in Tyler
- Tranquil Clinical Research · Webster, TX 77598More trials in Webster
VA
- Virginia Cancer Specialists · Fairfax, VA 22031More trials in Fairfax
WA
- Northwest Medical Specialities. PLLC · Bonney Lake, WA 98391More trials in Bonney Lake
- Swedish Cancer Institute - Edmonds Campus · Edmonds, WA 98026More trials in Edmonds
- Swedish Cancer Institute Edmonds Campus · Edmonds, WA 98026More trials in Edmonds
- Northwest Medical Specialities.PLLC · Federal Way, WA 98003More trials in Federal Way
- Northwest Medical Specialities. PLLC · Gig Harbor, WA 98332More trials in Gig Harbor
- American Oncology Network Vista Oncology Division-West office · Olympia, WA 98502More trials in Olympia
- American Oncology Network Vista Oncology Division-East office · Olympia, WA 98506More trials in Olympia
- Northwest Medical Specialties, PPLC · Puyallup, WA 98373More trials in Puyallup
- Swedish Cancer Institute · Seattle, WA 98104More trials in Seattle
- Swedish Medical Center · Seattle, WA 98122More trials in Seattle
- Exigent Research, LLC · Tacoma, WA 98405More trials in Tacoma
- Northwest Medical Specialities, PLLC · Tacoma, WA 98405More trials in Tacoma