RECRUITING

A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors

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Conditions

Breast NeoplasmsGastroesophageal Junction AdenocarcinomaHER2 Low Breast NeoplasmsHER2 Positive Breast NeoplasmsStomach NeoplasmsTriple Negative Breast NeoplasmsMetastatic Breast CancerMetastatic Gastric CancerAdvanced Breast CancerAdvanced Gastric CancerBreast CancerGastric CancerGCGEJHER2-Low Breast CancerHER2-Positive Breast CancerSeattle Genetics

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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 clinical trial is studying solid tumor cancers. A solid tumor is one that starts in part of your body like your lungs or liver instead of your blood. Once they've grown bigger in one spot or spread to other parts of the body, they're harder to treat. This is called advanced or metastatic cancer. Participants in this study must have breast cancer or gastric cancer. Participants must have tumors that have HER2 on them. This allows the cancer to grow more quickly or spread faster. There are few treatment options for patients with advanced or metastatic solid tumors that express HER2. This clinical trial uses an experimental drug called disitamab vedotin (DV). Disitamab vedotin is a type of antibody drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. This clinical trial uses a drug called tucatinib, which has been approved to treat cancer in the United States and some other countries. This drug is sold under the brand name TUKYSA®. This study will test how safe and how well DV with tucatinib works for participants with solid tumors. This study will also test what side effects happen when participants take these drugs. A side effect is anything a drug does to the body besides treating the disease.

Official Title

A Phase 1b/2 Open-Label Study of Disitamab Vedotin in Combination With Other Anticancer Therapies in Solid Tumors

Quick Facts

Study Start:2024-05-20
Study Completion:2030-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06157892

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. * Measurable disease according to RECIST v1.1
  2. * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
  3. * Histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma or breast carcinoma
  4. * Locally-advanced, unresectable, or metastatic stage
  5. * Must have experienced disease progression on or after standard of care therapies or be intolerant of standard of care therapies.
  6. * Histologically or cytologically confirmed diagnosis of breast carcinoma
  7. * Locally-advanced, unresectable, or metastatic stage
  8. * HER2-low status determined by most recent local assessment (IHC 1+ or IHC 2+/ISH-negative)
  9. * Prior therapies requirements
  10. * No more than 3 prior systemic cytotoxic chemotherapy regimens (including ADCs) for LA/mBC.
  11. * Participants with known BRCA mutation must have received a PARP-inhibitor where available and not medically contraindicated
  12. * Have progression on or after, or intolerant to, T-DXd, sacituzumab govitecan, or other topoisomerase I inhibitor therapies, if available as local standard of care therapy
  13. * Participants with HR+ tumors must have intolerance to endocrine therapy or endocrine therapy refractory disease:
  14. * Progressed on ≥2 lines of endocrine therapy for LA/mBC AND had received a CDK4/6 inhibitor in the adjuvant or metastatic setting OR
  15. * Progressed on 1 line of endocrine therapy for LA/mBC AND had a relapse while on adjuvant endocrine therapy after definitive surgery for primary tumor AND had received a CDK4/6 inhibitor in the adjuvant or advanced setting
  16. * Participants with HR negative, HER2-low and PD-L1-positive (CPS 10 or greater) tumors must have received pembrolizumab with chemotherapy if available as local standard of care therapy.
  17. * Participants with HR negative, HER2-low and PD-L1-positive (CPS 10 or greater) tumors must have received pembrolizumab (or other PD-(L)1 inhibitor) with chemotherapy if available as local standard of care therapy and not medically contraindicated.
  18. * Histologically or cytologically confirmed diagnosis breast carcinoma
  19. * Locally-advanced, unresectable, or metastatic stage
  20. * HER2+ status determined by most recent local assessment (IHC 3+ or IHC 2+/ISH+)
  21. * Participants must have:
  22. * Received prior trastuzumab, pertuzumab and a taxane if available as local standard of care therapy for advanced disease.
  23. * Have progression on or after, or intolerant to, T-DXd or other topoisomerase I inhibitor therapies
  24. * No more than 3 prior systemic cytotoxic chemotherapy regimens (including ADCs) for LA/mBC
  25. * Histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma
  26. * Locally-advanced, unresectable, or metastatic stage
  27. * HER2-low expression defined as IHC 1+ or IHC 2+/ISH-negative determined by most recent local assessment
  28. * Willing and able to provide archival or newly obtained formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks
  29. * Participants must have received:
  30. * Prior systemic therapy with platinum, fluorouracil, or taxane for locally advanced unresectable or metastatic disease
  31. * Progression within 6 months of last dose of (neo)adjuvant cytotoxic chemotherapy is considered as 1 line of systemic therapy for LA/mGC/GEJC
  32. * Prior anti-PD-(L)1 therapy is allowed
  33. * No more than 2 prior systemic cytotoxic chemotherapy regimens (including ADC) for LA/mGC/GEJC
  34. * Must not have received prior treatment with HER2 directed therapy
  35. * Histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma
  36. * Locally-advanced, unresectable, or metastatic stage
  37. * HER2+ status determined by most recent local assessment (IHC 3+ or IHC 2+/ISH+)
  38. * Participants must have:
  39. * Received prior trastuzumab plus fluoropyrimidine and platinum containing chemotherapy if no contraindication.
  40. * Prior T-DXd treatment is allowed
  41. * Prior PD1 inhibitor therapy is allowed
  42. * No more than 2 prior systemic cytotoxic chemotherapy regimens (including ADCs) for LA/mGC/GEJC
  1. * Known hypersensitivity to any excipient contained in the drug formulation of disitamab vedotin or tucatinib
  2. * Prior therapy with ADCs with MMAE payload
  3. * Prior therapy with tucatinib
  4. * Active CNS and/or leptomeningeal metastasis.
  5. * Participants who have received prior systemic anticancer treatment including investigational agents within 4 weeks prior to first dose of study treatment
  6. * History of other invasive malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.
  7. * Unable to swallow oral tablets or capsules or any significant GI disease which would preclude the adequate oral absorption of medications

Contacts and Locations

Study Contact

Pfizer CT.gov Call Center
CONTACT
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Principal Investigator

Pfizer CT.gov Call Center
STUDY_DIRECTOR
Pfizer

Study Locations (Sites)

Arizona Cancer Center / University of Arizona
Tucson, Arizona, 85719
United States
Banner-University Medical Center Tucson Campus
Tucson, Arizona, 85719
United States
The University of Arizona Cancer Center-North Campus Pharmacy, Attn: Kelly Myrdal
Tucson, Arizona, 85719
United States
The University of Arizona Cancer Center-Main
Tucson, Arizona, 85724
United States
Chao Family Comprehensive Cancer Center University of California Irvine
Orange, California, 92868
United States
UC Irvine Medical Center
Orange, California, 92868
United States
University of California, San Francisco | HDFCCC - Hematopoietic Malignancies
San Francisco, California, 94158
United States
UCLA Department of Medicine - Hematology & Oncology
Santa Monica, California, 90504
United States
Colorado West Healthcare System, dba Community Hospital
Grand Junction, Colorado, 81505
United States
Colorado West Healthcare, dba Grand Valley Oncology
Grand Junction, Colorado, 81505
United States
Danbury Hospital
Danbury, Connecticut, 06810
United States
The Whittingham Cancer Center / Norwalk Hospital
Norwalk, Connecticut, 06856
United States
Georgetown University Medical Center
Washington, District of Columbia, 20007
United States
MedStar Georgetown University Hospital
Washington, District of Columbia, 20007
United States
Moffitt Cancer Center - International Plaza
Tampa, Florida, 33607
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
United States
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, 33612
United States
Moffitt McKinley Hospital
Tampa, Florida, 33612
United States
Moffitt Cancer Center at Wesley Chapel
Wesley Chapel, Florida, 33544
United States
Georgia Cancer Specialists - Athens
Athens, Georgia, 30606
United States
Georgia Cancer Specialists - Annex
Atlanta, Georgia, 30341
United States
Atlanta Cancer Care - Atlanta
Atlanta, Georgia, 30342
United States
Georgia Cancer Specialists-Northside
Atlanta, Georgia, 30342
United States
Northside Hospital, Inc.- Central Research Department
Atlanta, Georgia, 30342
United States
Northside Hospital
Atlanta, Georgia, 30342
United States
Georgia Cancer Specialists - Blairsville
Blairsville, Georgia, 30512
United States
Georgia Cancer Specialists - Canton
Canton, Georgia, 30115
United States
Atlanta Cancer Care - Cumming
Cumming, Georgia, 30041
United States
Georgia Cancer Specialists - Cumming
Cumming, Georgia, 30041
United States
Georgia Cancer Specialists - Decatur
Decatur, Georgia, 30033
United States
Suburban Hematology-Oncology Associates - Duluth
Duluth, Georgia, 30096
United States
Suburban Hematology-Oncology Associates- Lawrenceville
Lawrenceville, Georgia, 30046
United States
Georgia Cancer Specialists - Macon
Macon, Georgia, 31217
United States
Georgia Cancer Specialists - Marietta
Marietta, Georgia, 30060
United States
Memorial Hospital
Shiloh, Illinois, 62269
United States
Siteman Cancer Center - Shiloh
Shiloh, Illinois, 62269
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
Massachusetts General Hospital.
Boston, Massachusetts, 02114
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02215
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Dana Farber Cancer Institute- Chestnut Hill
Newton, Massachusetts, 02459
United States
Siteman Cancer Center - West County
Creve Coeur, Missouri, 63141
United States
Siteman Cancer Center - North County
Florissant, Missouri, 63031
United States
Saint Luke's Cancer Institute LLC
Kansas City, Missouri, 64111
United States
Saint Luke's Hospital Investigational Pharmacy
Kansas City, Missouri, 64111
United States
St Lukes Hospital
Kansas City, Missouri, 64111
United States
Barnes-Jewish Hospital
Saint Louis, Missouri, 63110
United States
Washington University in St Louis.
Saint Louis, Missouri, 63110
United States
Washington University School of Medicine - Siteman Cancer Center
Saint Louis, Missouri, 63110
United States
Siteman Cancer Center - South County
Saint Louis, Missouri, 63129
United States
Siteman Cancer Center - St Peters
Saint Peters, Missouri, 63376
United States
Renown Oncology
Reno, Nevada, 89502
United States
Renown Regional Medical Center
Reno, Nevada, 89502
United States
San Juan Oncology Associates
Farmington, New Mexico, 87401
United States
Memorial Sloan Kettering Cancer Center - Main Hospital
New York, New York, 10065
United States
Zangmeister Cancer Center
Columbus, Ohio, 43219
United States
Saint Francis Hospital / Bon Secours - South Carolina
Greenville, South Carolina, 29607
United States
Sarah Cannon Research Institute - Pharmacy
Nashville, Tennessee, 37203
United States
SCRI Oncology Partners
Nashville, Tennessee, 37203
United States
Tennessee Oncology-Nashville/Sarah Cannon Research Institute
Nashville, Tennessee, 37203
United States
Parkland Health and Hospital System
Dallas, Texas, 75235
United States
University of Texas Southwestern Medical Center Simmons Cancer Center - Redbird
Dallas, Texas, 75237
United States
University of Texas Southwestern Medical Center - Simmons Cancer Center
Dallas, Texas, 75390
United States
University of Texas Southwestern Medical Center Clinical Lab-Zale Lipshy University Hospital
Dallas, Texas, 75390
United States
University of Texas Southwestern Medical Center-Simmons Cancer Center Pharmacy
Dallas, Texas, 75390
United States
University of Texas Southwestern Medical Center-William P. Clements Jr. University Hospital
Dallas, Texas, 75390
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States
University of Texas Southwestern Simmons Cancer Center - Fort Worth
Fort Worth, Texas, 76104
United States
University of Texas Southwestern Medical Center Clinical Laboratory - Richardson/Plano
Richardson, Texas, 75080
United States
Harborview Medical Center
Seattle, Washington, 98104
United States
Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington
Seattle, Washington, 98109
United States
University of Washington Medical Center
Seattle, Washington, 98195
United States
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, 53718
United States
Carbone Cancer Center / University of Wisconsin
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: Seagen, a wholly owned subsidiary of Pfizer

  • Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

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 Date2024-05-20
Study Completion Date2030-01-31

Study Record Updates

Study Start Date2024-05-20
Study Completion Date2030-01-31

Terms related to this study

Keywords Provided by Researchers

  • Breast Cancer
  • Gastric Cancer
  • GC
  • GEJ
  • HER2-Low Breast Cancer
  • HER2-Positive Breast Cancer
  • Seattle Genetics

Additional Relevant MeSH Terms

  • Breast Neoplasms
  • Gastroesophageal Junction Adenocarcinoma
  • HER2 Low Breast Neoplasms
  • HER2 Positive Breast Neoplasms
  • Stomach Neoplasms
  • Triple Negative Breast Neoplasms
  • Metastatic Breast Cancer
  • Metastatic Gastric Cancer
  • Advanced Breast Cancer
  • Advanced Gastric Cancer