Pancreatic Cancer Clinical Trial
Official title:
A Phase 2 Study of Futibatinib in Combination With PD-1 Antibody-based Standard of Care Therapy in Patients With Solid Tumors.
NCT number | NCT05945823 |
Other study ID # | TAS-120-206 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | July 13, 2023 |
Est. completion date | May 2025 |
This is a nonrandomized, uncontrolled, open-label, multicenter Phase 2 study to evaluate the efficacy, safety, and tolerability of futibatinib in combination with PD-1 antibody-based SoC therapy in adult patients with solid tumors.
Status | Recruiting |
Enrollment | 66 |
Est. completion date | May 2025 |
Est. primary completion date | January 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion criteria 1. Is =18 years of age at the time of informed consent 2. Cohort A: Histologically or cytologically confirmed, locally advanced, unresectable or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus or advanced/metastatic Siewert type 1 adenocarcinoma of the esophagogastric junction (EGJ). 3. Cohort B: Histologically or cytologically confirmed, locally advanced, unresectable or metastatic pancreatic ductal adenocarcinoma. 4. No prior systemic treatment for locally advanced, unresectable or metastatic disease 5. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. 6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 7. Adequate organ function 8. Able to take medications orally Exclusion Criteria 1. Has locally advanced disease that is resectable or potentially curable with radiation therapy (as determined by local investigator). 2. Has an adenocarcinoma histology and is eligible to receive approved targeted therapy (eg, HER-2 positive patients). 3. Has received prior treatment with an anti-PD-1/PD-L1 or FGF/FGFR targeting drug, or any other agent directed to stimulatory or co-stimulatory T-cell receptor. 4. Has known additional malignancy that is progressing or requires active treatment. 5. History or current evidence of calcium and phosphate homeostasis disorder 6. Current evidence of clinically significant retinal disorder 7. Pregnant or lactating female. 8. Has known hypersensitivity or severe reaction to any of the study drugs or their excipients. 9. Has a diagnosis of immunodeficiency. 10. Has known human immunodeficiency virus (HIV) and/or history of Hepatitis B or C infections, or known to be positive for Hepatitis B antigen (HBsAg)/ Hepatitis B virus (HBV) DNA or Hepatitis C antibody or RNA. 11. Has an active autoimmune disease that has required systemic treatment in the past 2 years 12. Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis. 13. Has had an allogenic tissue/organ transplant. |
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier Regional Universitaire de Lille | Lille Cedex | |
France | Centre Hospitalier Regional Universitaire Poitiers | Poitiers | |
Germany | Krankenhaus Nordwest gGmbH | Frankfurt | |
Germany | Universitaetsmedizin Mainz | Mainz | |
Spain | Hospital Universitari Vall d'Hebron | Barcelona | |
Spain | Hospital Universitario 12 de Octubre | Madrid | |
United States | Roswell Park Comprehensive Cancer Center (RPCCC) (Roswell Park Cancer Institute (RPCI)) | Buffalo | New York |
United States | Gabrail Cancer Center Research LLC | Canton | Ohio |
United States | Dallas VA Medical Center | Dallas | Texas |
United States | Rocky Mountain Cancer Centers Midtown | Denver | Colorado |
United States | Henry Ford Health System | Detroit | Michigan |
United States | Inova Schar Cancer Institute | Fairfax | Virginia |
United States | Alliance Cancer Specialists | Horsham | Pennsylvania |
United States | Gundersen Lutheran Health System | La Crosse | Wisconsin |
United States | Mount Sinai Comprehensive Cancer Center | Miami Beach | Florida |
United States | The Minniti Center - Medical Oncology and Hematology | Mickleton | New Jersey |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | NYU Langone | New York | New York |
United States | Blue Ridge Cancer Care | Roanoke | Virginia |
United States | University of California Los Angeles UCLA - Cancer Care - Santa Monica | Santa Monica | California |
United States | Virginia Mason Medical Center | Seattle | Washington |
United States | Moffitt Cancer Center and Research Institute | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Taiho Oncology, Inc. |
United States, France, Germany, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ORR by investigator assessment | Defined as the proportion of patients experiencing a best overall response of partial response (PR) or complete response (CR) (per RECIST 1.1), based on investigator assessment | 12 months | |
Secondary | Treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0 | Safety will be assessed based on reported AEs (including SAEs), graded by CTCAE V5.0., and dose modifications. | 12 months | |
Secondary | DoR per investigator assessment | defined as time from the first documentation of response to the first documentation of objective tumor progression or death due to any cause, whichever occurs first | 12 months | |
Secondary | DCR per investigator assessment | defined as percentage of patients who achieve complete response, partial response or stable disease per RECIST 1.1 by investigator assessment | 12 months | |
Secondary | PFS per investigator assessment | defined as the time from date of enrollment to the date of disease progression based on Investigator assessment of radiographic images or death, whichever occurs first | 12 months | |
Secondary | 6-month PFS rate | defined as percentage of patients without disease progression within 6 months of enrollment | 12 months |
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