RECRUITING

A Study of SGN-B6A in Advanced Solid Tumors

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1 Study of SGN-B6A in Advanced Solid Tumors

Quick Facts

Study Start:2020-06-08
Study Completion:2028-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04389632

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Disease indication
  2. * Participants must have histologically or cytologically confirmed metastatic or unresectable solid malignancy within one of the tumor types listed below (dependent on study part).
  3. * Non-small cell lung cancer (NSCLC)
  4. * Head and neck squamous cell cancer (HNSCC)
  5. * Advanced HER2-negative breast cancer
  6. * Esophageal squamous cell carcinoma (ESCC)
  7. * Esophageal/Gastro-esophageal junction adenocarcinoma (EAC/GEJ)
  8. * Cutaneous squamous cell cancer (cSCC)
  9. * Exocrine pancreatic adenocarcinoma
  10. * Bladder cancer
  11. * Cervical cancer
  12. * Gastric cancer
  13. * High grade serous ovarian cancer (HGSOC)
  14. * 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.
  15. * 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.
  16. * 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).
  17. * Part D only: Participants must be treatment naïve for locally advanced or metastatic systemic therapy.
  18. * Participants enrolled in the following study parts should have a tumor site accessible for biopsy and agree to biopsy as follows:
  19. * 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.
  20. * Biology expansion cohort: pretreatment biopsy and on-treatment (Cycle 1) biopsy
  21. * An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  22. * Measurable disease per the RECIST v1.1 at baseline
  23. * 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.
  24. * Known active central nervous system metastases. Participants with previously treated brain metastases may participate provided they:
  25. * are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment,
  26. * have no new or enlarging brain metastases, and
  27. * are off of corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to first dose of study drug.
  28. * Carcinomatous meningitis
  29. * Previous receipt of an MMAE-containing agent or an agent targeting integrin beta-6
  30. * 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
  31. * 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.
  32. * Routine antimicrobial prophylaxis is permitted
  33. * Grade ≥3 pulmonary disease unrelated to underlying malignancy. This includes clinically severe pulmonary function compromise resulting from clinically significant pulmonary illnesses
  34. * 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).
  35. * 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
  36. * Known diffusing capacity of the lung for carbon monoxide (DLCO; adjusted for hemoglobin) \<50% predicted
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Seagen Trial Information Support
CONTACT
866-333-7436
clinicaltrials@seagen.com

Principal Investigator

Medical Monitor
STUDY_DIRECTOR
Seagen Inc.

Study Locations (Sites)

Alaska Oncology and Hematology
Anchorage, Alaska, 99508
United States
Highlands Oncology Group
Fayetteville, Arkansas, 72703
United States
Providence Medical Foundation
Fullerton, California, 92835
United States
Cancer and Blood Specialty Clinic
Los Alamitos, California, 92720
United States
Memorial Cancer Institute
Hollywood, Florida, 33021
United States
Florida Cancer Specialists - Lake Nona
Orlando, Florida, 32827
United States
Memorial Cancer Institute
Pembroke Pines, Florida, 33028
United States
University of Chicago Medical Center
Chicago, Illinois, 60637-1470
United States
Ft Wayne Medical Oncology and Hematology, Inc TRIO
Fort Wayne, Indiana, 46804
United States
University of Kansas Cancer Center
Westwood, Kansas, 66205
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Allina Health Cancer Institute
Saint Paul, Minnesota, 55102
United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
United States
New York Cancer and Blood Specialists
Bronx, New York, 10469
United States
New York Cancer and Blood Specialists
New Hyde Park, New York, 11042
United States
New York Cancer and Blood Specialists
New York, New York, 10028
United States
New York Cancer and Blood Specialists
Shirley, New York, 11967
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Oklahoma University at Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
United States
Providence Portland Medical Center
Portland, Oregon, 97213
United States
Providence Portland Medical Center
Portland, Oregon, 97225
United States
Sanford Cancer Center
Sioux Falls, South Dakota, 57104
United States
MD Anderson Cancer Center / University of Texas
Houston, Texas, 77030-4095
United States
Oncology Consultants, PA
Houston, Texas, 77030
United States
Tranquil Clinical Research & Consulting Services, LLC
Houston, Texas, 77598
United States
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
United States
UT Health East Texas Hope Cancer Center
Tyler, Texas, 75701
United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031
United States
Vista Oncology Inc PS
Olympia, Washington, 98506
United States
Northwest Medical Specialties, PPLC
Tacoma, Washington, 98405
United States

Collaborators and Investigators

Sponsor: Seagen Inc.

  • Medical Monitor, STUDY_DIRECTOR, Seagen Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-06-08
Study Completion Date2028-02-28

Study Record Updates

Study Start Date2020-06-08
Study Completion Date2028-02-28

Terms related to this study

Keywords Provided by Researchers

  • NSCLC
  • HNSCC
  • cSCC
  • ESCC
  • EAC
  • GEJ
  • HGSOC
  • Advanced HER2-Negative Breast Cancer
  • High Grade Serous Ovarian Cancer
  • Non-Small Cell Lung Cancer
  • Head and Neck Squamous Cell Cancer
  • Esophageal Cancer
  • Bladder Cancer
  • Cervical Cancer
  • Gastric Cancer
  • Seattle Genetics

Additional Relevant MeSH Terms

  • Carcinoma, Non-Small Cell Lung
  • Squamous Cell Carcinoma of Head and Neck
  • HER2 Negative Breast Neoplasms
  • Esophageal Squamous Cell Carcinoma
  • Esophageal Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma
  • Ovarian Neoplasms
  • Cutaneous Squamous Cell Cancer
  • Exocrine Pancreatic Adenocarcinoma
  • Urinary Bladder Neoplasms
  • Uterine Cervical Neoplasms
  • Stomach Neoplasms