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Derazantinib Alone or in Combination With Paclitaxel, Ramucirumab or Atezolizumab in Gastric Adenocarcinoma

Trial Status: Active

The purpose of this study is to evaluate the efficacy of derazantinib monotherapy or derazantinib in combination with paclitaxel, ramucirumab, or atezolizumab in patients with HER2-negative adenocarcinoma of the stomach or gastro-esophageal junction harboring FGFR2 genetic aberrations (GA).

Inclusion Criteria

  • Histologically-confirmed adenocarcinoma of the gastro-esophageal junction or stomach
  • Male or female aged ≥ 18 years
  • Negative HER2 status obtained from the most recent available tissue sample
  • Inoperable recurrent, locally advanced adenocarcinoma or progressing stage IV adenocarcinoma of the gastro-esophageal junction or stomach, and disease progression after either standard first- or second-line treatment (Substudy 1), or after standard first-line treatment (Substudies 2 and 3)
  • Positive test for eligible FGFR aberrations
  • For Substudies 1 and 3, measurable disease as defined by the Investigator using RECIST 1.1 criteria
  • ECOG PS of 0 or 1
  • Men and women of childbearing potential must agree to avoid impregnating a partner or becoming pregnant, respectively, during the study, and for at least 150 days after the last dose of either investigational drug

Exclusion Criteria

  • Prior anticancer or investigational drug treatment within an interval shorter than the following, as applicable:
  • One chemotherapy or biological (e.g., antibody) cycle interval
  • Five half-lives of any small molecule investigational or licensed medicinal product
  • Two weeks, for any investigational medicinal product with an unknown half-life
  • Four weeks of curative radiotherapy
  • Seven days of palliative radiotherapy
  • 28 days of radiotherapy
  • Prior treatment with FGFR Inhibitors (all substudies), and prior treatment with taxanes within 6 months prior to randomization and/or anti-VEGF(R) therapeutic antibody or pathway-targeting agents (Substudies 2 and 3), and prior treatment with anti-programmed cell death receptor-1 (PD-1) or anti-programmed death ligand-1 (PD-L1) therapeutic antibody or pathway-targeting agents (Substudy 3)
  • Concurrent evidence of clinically significant corneal or retinal disorder
  • History of clinically significant cardiac disorders and/or a QT interval corrected by Fridericia's formula (QTcF) > 450 ms for males or > 460 ms for females
  • For Substudies 1 and 3, known CNS metastases
  • Concurrent uncontrolled or active infection with human immunodeficiency virus (HIV; known HIV 1/2 antibodies positive); active hepatitis B virus (HBV) and hepatitis C virus (HCV) co-infection; active tuberculosis (for Substudies 2 and 3)
  • Child-Pugh B or C liver cirrhosis, or a history of hepatic encephalopathy, hepatorenal syndrome, or clinically-meaningful ascites related to cirrhosis (for Substudies 2 and 3)
  • Administration of a live, attenuated vaccine within 30 days prior to randomization (for Substudy 3)
  • Treatment with systemic corticosteroids (except for steroidal replacement therapy) or other systemic immunosuppressive medications within 2 weeks prior to first dose of study drug or anticipated requirement for systemic immunosuppressive medications during the study (for Substudy 3)

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE

The study comprises three open-label substudies in patients with HER2-negative adenocarcinoma

of the stomach or gastro-esophageal junction harboring FGFR2 gene translocations, FGFR2 gene

amplifications, or FGFR1-3 mutations. Patients will be treated with single-agent derazantinib

or derazantinib in combination with paclitaxel, ramucirumab, or atezolizumab. The study

enrolls patients with either metastatic or recurrent locally advanced HER2-negative

adenocarcinoma of the stomach or gastro-esophageal junction inoperable at the time of

screening, and radiologically confirmed disease progression after one or at least one

standard treatment regimen.

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
Basilea Pharmaceutica

  • Primary ID DZB-CS-202
  • Secondary IDs NCI-2021-01098
  • Clinicaltrials.gov ID NCT04604132