RECRUITING

A Study of SGN-CEACAM5C in Adults With 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 clinical trial is studying advanced solid tumors. Solid tumors are cancers that start in a part of your body like your lungs or liver instead of your blood. Once tumors have grown bigger in one place but haven't spread, they're called locally advanced. If your cancer has spread to other parts of your body, it's called metastatic. When a cancer has gotten so big it can't easily be removed or has spread to other parts of the body, it is called unresectable. These types of cancer are harder to treat. Participants in this study must have cancer that has come back or did not get better with treatment. Participants must have a solid tumor cancer that can't be treated with standard of care drugs. This clinical trial uses an experimental drug called PF-08046050. PF-08046050 is a type of antibody-drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. They may also stick to some normal cells. This study will test the safety of PF-08046050 in participants with solid tumors that are hard to treat or have spread throughout the body. This study has 5 different study parts. Part A and Part B of the study will find out how much PF-08046050 should be given to participants. Part C will use the information from Parts A and B to see if PF-08046050 is safe and if it works to treat certain solid tumor cancers. Part D and E of the study, together with information from Parts A and B, will find out how much PF-08046050 should be given in combination with other anti-cancer agents. Part E will use the information from Parts A, B, and D to see if PF-08046050 is safe in combination with other anti-cancer agents and if it works to treat a certain solid tumor.

Official Title

An Open-label Phase 1 Study to Investigate PF-08046050 (SGN-CEACAM5C) in Adults With Advanced Solid Tumors

Quick Facts

Study Start:2023-11-20
Study Completion:2030-09-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06131840

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. 1. Tumor type:
  2. * Participants in Part A (dose escalation) and Part B (dose optimization) must have histologically- or cytologically-confirmed metastatic or unresectable solid tumor malignancy. Must have relapsed, refractory, or progressive disease, and should have no appropriate standard therapy available.
  3. * Participants in Part A must have one of the following tumor types: colorectal cancer (CRC); gastric carcinoma (GC) or gastroesophageal junction adenocarcinoma (GEJ); non-small cell lung cancer (NSCLC); or pancreatic ductal adenocarcinoma (PDAC).
  4. * The tumor types to be enrolled in Part B will be identified by the sponsor from among those specified in Part A.
  5. * Participants in Part C (dose expansion) must have one of the following histologically- or cytologically-confirmed metastatic or unresectable solid tumor malignancies.
  6. * CRC (adenocarcinoma of the colon or rectum) and must have received no more than 2 prior chemotherapy regimens for the treatment of advanced colorectal cancer and evidence of either progressive disease or intolerance to their last regimen.
  7. * PDAC with one or more metastatic lesions measurable by computed tomography/magnetic resonance imaging according to RECIST v1.1 criteria; and must have received no more than 1 prior chemotherapy regimen for the treatment of advanced PDAC and evidence of either progressive disease or intolerance to that regimen.
  8. * GC or GEJ and must have received prior platinum and fluoropyrimidine-based chemotherapy.
  9. * NSCLC and must have received platinum-based therapy. If eligible and consistent with local standard of care must have received a PD-1/PD-L1 inhibitor. In addition, participants with tumor genomic mutations/alterations for which approved targeted therapies are available per local standard of care, must have received such therapies.
  10. * Small cell lung cancer (SCLC) and must have received platinum-based therapy for extensive-stage disease and no more than 3 prior lines of therapy. If eligible and consistent with local standard of care must have received a PD 1/PD-L1 inhibitor.
  11. * CRC participants in Part D and Part E (bevacizumab combination therapy) must have histologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum. Received a maximum of 2 prior chemotherapy regimens for the treatment of advanced colorectal cancer and had demonstrated progressive disease or intolerance to their last regimen.
  12. * CRC participants in Part D and Part E (5FU/LV + bevacizumab and 5FU/LV + oxaliplatin + bevacizumab combination therapy) must have histologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum. Must not have received a prior TOPO1 inhibitor (such as irinotecan or nanoliposomal irinotecan) in any setting. 1L cohorts: No prior chemotherapy for advanced disease. 2L cohorts (applicable to 5FU/LV + bevacizumab combination only): 1 prior chemotherapy regimen for the treatment of advanced disease, which must have included a fluoropyrimidine and oxaliplatin.
  13. 2. Participants enrolled in the following study parts should have a tumor site that is accessible for biopsy(ies) and agree to biopsy(ies) and/or submission of archival tissue:
  14. * Monotherapy dose optimization (Part B)
  15. * Monotherapy (Part C) and combination therapy (Part E) disease-specific expansion cohorts
  16. 3. An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
  17. 4. Measurable disease per Response Evaluation in Solid Tumors (RECIST) v1.1 at baseline.
  1. 1. Previous exposure to CEACAM5-targeted therapy.
  2. 2. Prior treatment with a TOPO1-targeting ADC (CPT payload), such as Enhertu (trastuzumab deruxtecan) or Trodelvy (sacituzumab govitecan).
  3. 3. History of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.
  4. 4. Active cerebral/meningeal disease related to the underlying malignancy. Participants with a history of cerebral/meningeal disease related to the underlying malignancy are allowed if prior central nervous system disease has been treated and the participant is clinically stable (defined as not having received steroid treatment for symptoms related to cerebral/meningeal disease for at least 2 weeks prior to enrollment and with no ongoing related AEs).
  5. 5. History of allergic reactions or hypersensitivity to bevacizumab or any of its excipients.
  6. 6. History of hypersensitivity to Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies.
  7. 7. Serious non-healing wound, non-healing ulcer, or non-healing bone fracture.
  8. 8. Deep venous thromboembolic event within 4 weeks prior to enrollment
  9. 9. Known coagulopathy that increases risk of bleeding, bleeding diatheses.
  10. 10. History of any life-threatening VEGF-related adverse event

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)

Mayo Clinic Hospital
Phoenix, Arizona, 85054
United States
Mayo Clinic
Scottsdale, Arizona, 85259
United States
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, 91010
United States
IP Address: City of Hope Investigational Drug Services(IDS)
Duarte, California, 91010
United States
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
Aurora, Colorado, 80045
United States
University of Colorado Hospital/University of Colorado
Aurora, Colorado, 80045
United States
University of Colorado Hospital
Aurora, Colorado, 80045
United States
Florida Cancer Specialists
Orlando, Florida, 32827
United States
Sarah Cannon Research Institute at Florida Cancer Specialists
Orlando, Florida, 32827
United States
School of Medicine
Baltimore, Maryland, 21205
United States
Sidney Kimmel Comprehensive Cancer at Johns Hopkins
Baltimore, Maryland, 21287
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
START Midwest
Grand Rapids, Michigan, 49546
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Sarah Cannon Research Institute - Pharmacy
Nashville, Tennessee, 37203
United States
SCRI Oncology Partners
Nashville, Tennessee, 37203
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, 78229
United States
START Mountain Region
Salt Lake City, Utah, 84119
United States
South Texas Accelerated Research Therapeutics Mountain Region
West Valley City, Utah, 84119
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 Date2023-11-20
Study Completion Date2030-09-12

Study Record Updates

Study Start Date2023-11-20
Study Completion Date2030-09-12

Terms related to this study

Keywords Provided by Researchers

  • CRC
  • NSCLC
  • PDAC
  • GC
  • GEJ
  • SCLC
  • Seattle Genetics

Additional Relevant MeSH Terms

  • Colorectal Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Stomach Neoplasms
  • Pancreatic Ductal Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma
  • Small Cell Lung Carcinoma