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JOURNAL ONKOLOGIE – STUDIE

Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors

Rekrutierend

NCT-Nummer:
NCT05945823

Studienbeginn:
Juli 2023

Letztes Update:
26.02.2024

Wirkstoff:
Futibatinib, Pembrolizumab, Cisplatin, 5-FU, Oxaliplatin, Leucovorin, levoleucovorin, Irinotecan

Indikation (Clinical Trials):
Pancreatic Neoplasms, Adenocarcinoma, Esophageal Neoplasms, Neoplasms, Squamous Cell, Carcinoma, Squamous Cell, Esophageal Squamous Cell Carcinoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Taiho Oncology, Inc.

Collaborator:
-

Kontakt

Studienlocations
(3 von 22)

University of California Los Angeles UCLA - Cancer Care - Santa Monica
90404 Santa Monica
United StatesNoch nicht rekrutierend» Google-Maps
Ansprechpartner:

Phone: 310-633-8400
E-Mail: lrosen@mednet.ucla.edu» Ansprechpartner anzeigen
Roswell Park Comprehensive Cancer Center (RPCCC) (Roswell Park Cancer Institute (RPCI))
14203 Buffalo
United StatesNoch nicht rekrutierend» Google-Maps
Ansprechpartner:

Phone: 716-845-2300
E-Mail: sarbajit.mukherjee@roswellpark.org» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Detailed Description:

Patients with locally advanced, unresectable or metastatic esophageal cancer (EC) or

pancreatic ductal adenocarcinoma (PDAC) will receive futibatinib in combination with

pembrolizumab plus standard of care (SOC) chemotherapy. Patients with EC will receive

Investigator choice of chemotherapy (FP or mFOLFOX6), patients with PDAC will receive

mFOLFIRINOX. Subjects will receive futibatinib in combination with pembrolizumab plus

standard of care (SOC) chemotherapy during induction phase of the study and will continue on

futibatinib in combination with pembrolizumab in consolidation phase.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. ORR by investigator assessment (Time Frame - 12 months):
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



Secondary outcome:

1. Treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0 (Time Frame - 12 months):
Safety will be assessed based on reported AEs (including SAEs), graded by CTCAE V5.0., and dose modifications.

2. DoR per investigator assessment (Time Frame - 12 months):
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

3. DCR per investigator assessment (Time Frame - 12 months):
defined as percentage of patients who achieve complete response, partial response or stable disease per RECIST 1.1 by investigator assessment

4. PFS per investigator assessment (Time Frame - 12 months):
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

5. 6-month PFS rate (Time Frame - 12 months):
defined as percentage of patients without disease progression within 6 months of enrollment

Studien-Arme

  • Experimental: Cohort A
    Patients with Esophageal cancer (Adenocarcinoma or Squamous cell cancer) will receive Futibatinib administered once daily on a continuous dosing regimen in combination with pembrolizumab plus investigator choice of SoC chemotherapy (FP or mFOLFOX6) for 6 cycles (induction phase) following by Futibatinib combination with pembrolizumab (consolidation phase).
  • Experimental: Cohort B
    Patients with PDAC will receive Futibatinib administered once daily on a continuous dosing regimen in combination with pembrolizumab plus mFOLFIRINOX for 6 cycles (induction phase) following by Futibatinib combination with pembrolizumab (consolidation phase) .

Geprüfte Regime

  • Futibatinib (TAS-120):
    TAS-120 20 mg tablets, oral; once daily
  • Pembrolizumab (MK-3475 / KEYTRUDA® / ):
    400 mg once every 6-week-cycle, via IV infusion.
  • Cisplatin (PLATINOL®):
    80 mg/m^2 Q3W via IV infusion, as part of investigator's choice FP chemotherapy
  • 5-FU (ADRUCIL®):
    4000 mg/m^2 Q3W via IV infusion, as part of investigator's choice FP chemotherapy or 400 mg/m^2 Q2W via bolus IV infusion followed by 2400 mg/m^2 Q2W via continuous IV infusion, as part of investigator's choice mFOLFOX6 chemotherapy. 2400 mg/m^2 Q2W via continuous IV infusion, as part of investigator's choice mFOLFOX6 chemotherapy. 2400 mg/m^2 Q2W via continuous IV infusion, as part of mFOLFIRINOX chemotherapy.
  • Oxaliplatin (ELOXATIN®):
    85 mg/m^2 Q2W via IV infusion, as part of mFOLFIRINOX or mFOLFOX6 chemotherapy. 2400 mg/m^2 Q2W via continuous IV infusion, as part of mFOLFIRINOX chemotherapy.
  • Leucovorin (calcium folinate / folinic acid / WELLCOVORIN® / ):
    400 mg/m^2 Q2W as part of mFOLFIRINOX or mFOLFOX6 chemotherapy.
  • Levoleucovorin (calcium levofolinate / levofolinic acid / FUSILEV® / ):
    200 mg/m^2 Q2W as part of investigator's choice mFOLFOX6 chemotherapy.
  • Irinotecan:
    150 mg/m^2 Q2W as part of mFOLFIRINOX chemotherapy.

Quelle: ClinicalTrials.gov


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