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Debio: 1347-201: A phase II basket study of the oral selective pan-FGFR inhibitor Debio 1347 in subjects with solid tumors harboring a fusion of FGFR1, FGFR2 or FGFR3 "The FUZE Clinical Trial"

Description

This study examines the efficacy of Debio 1347 administered at the recommended Phase II dose of 80 mg in subjects with solid tumors harboring FGFR1-3 gene fusion/rearrangement. The study will include 3 cohorts of subjects comprising biliary tract cancer (Cohort 1), urothelial cancer (Cohort 2) and, in Cohort 3, all other solid tumor histologies not included in Cohorts 1-2, such as non-small cell lung cancer (NSCLC), head and neck cancer, thyroid cancer, oral cancer, breast cancer, prostate cancer and others but excluding primary brain tumors.

Status

Accepting new patients

Primary Study Objective(s)

The objective of this trial is to assess the efficacy of Debio 1347 in terms of objective response rate (ORR) in subjects with solid tumors harboring FGFR1-3 gene fusion/rearrangement.

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who:

  • Have a cytologically or histologically confirmed advanced solid tumor.
  • Have radiographic progression on prior systemic therapy (prior localized therapy [i.e., radiation, ablation, embolization] is allowed provided radiographic progression out-of-field or in the treatment field is shown.)
  • Are over 18 years of age
  • Have Locally-advanced, unresectable or metastatic disease harboring an FGFR1-3 gene fusion/rearrangement potentially leading to a functional FGFR aberrant protein, identified through local and/or central molecular assay
  • Had at least one prior standard therapy appropriate for tumor type and stage of disease, in particular:
    • Biliary tract cancer subjects must have progressed on/after gemcitabine-based chemotherapy, including subjects who progressed within 6 months of gemtabicine-based adjuvant chemotherapy (Subjects may have received additional chemotherapy after documented intolerance to gemcitabine.)
    • Urothelial cancer subjects must have progressed on/after cisplatin-based or carboplatin-based chemotherapy either given for advanced disease or within 12 months from completion if given as neoadjuvant or adjuvant therapy and anti-PD1/PDL1 therapy, unless not available, contraindicated for some reasons or refused by the patient
    • NSCLC subjects must have progressed on chemotherapy and anti-PD1/PDL1 therapy, unless contraindicated for some reasons; subjects with known EGFR mutations, ALK rearrangement or BRAF V600E mutation must have received the relevant target therapy, unless not available
    • For all other tumor types, subjects must have progressed on/after appropriate standard of care (SOC) therapy (evidence-based level 1). Subjects who harbor genomic aberrations for which approved target therapy is available must have received such therapy. HER2+ or ER/PR+ breast cancer subjects should have received at least one line of HER2-targeted or ER-targeted, respectively
  • Have measurable disease according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria version 1.1
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1.

Excluding patients who:

  • Have a history of hypersensitivity to any of the excipients in the Debio 1347 formulation (lactose hydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, sodium lauryl sulfate and magnesium stearate)
  • Had a prior treatment with a FGFR1-3 selective inhibitor
  • Have a history and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting calcified lymph nodes, lung nodules and asymptomatic vascular or cartilage/tendon calcifications.
  • Have current evidence of clinically significant corneal or retinal disorder confirmed by ophthalmologic examination
  • Had chemotherapy or radiotherapy within 2 weeks prior to initial dosing with Debio 1347
  • Received an investigational agent within 2 weeks prior to initial dosing with Debio 1347 (3 weeks for immune checkpoint inhibitors)
  • Had surgery requiring general anesthesia, except diagnostic biopsy or local procedure, within 3 weeks prior to initial dosing with Debio 1347 and/or if the subject has not fully recovered from the surgery
  • Has Grade > 1 AEs or toxicities from previous treatments except:
    • Albumin (≥ 2.5 g/dL is allowed).
    • AST and ALT in subjects with liver metastases (≤ 5 × ULN is allowed).
    • Alkaline phosphatase (ALP) in subjects with bone metastases (≤ 5 × ULN is allowed).
    • Any grade of alopecia is allowed.
    • Other Grade 1-2 clinically insignificant laboratory abnormalities are allowed.
  • Has symptomatic or unstable brain metastases < 1 month (Of note: Subjects with asymptomatic stable and treated brain metastases are eligible).
Learn more about your cancer
     

Accepting new patients

 

Learn more at

clinicaltrials.gov

 

Principal Investigator(s)