🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT04389632
Recruiting Phase 1

A Study of Sigvotatug Vedotin in Advanced Solid Tumors

NCT04389632 · tracked via the Priya Life Science USA tracker
Sponsor
Seagen, a wholly owned subsidiary of Pfizer
Phase
Phase 1
Started
2020-06-08
Last updated
2026-07-06

Condition(s) studied

Carcinoma, Non-Small Cell LungSquamous Cell Carcinoma of Head and NeckHER2 Negative Breast NeoplasmsEsophageal Squamous Cell CarcinomaEsophageal AdenocarcinomaGastroesophageal Junction AdenocarcinomaOvarian NeoplasmsCutaneous Squamous Cell CancerExocrine Pancreatic AdenocarcinomaUrinary Bladder NeoplasmsUterine Cervical NeoplasmsStomach Neoplasms

Investigational drug(s) / intervention(s)

sigvotatug vedotinpembrolizumabcisplatincarboplatin

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (158)

FacilityCityRegionStatus
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 the USA

Other trials for the same condition

Official registry record

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 the USA