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Protocol No. UW18125

Principal Investigator Uboha, Nataliya

Phase II

Age Group Adult

Scope National

Sponsor Type Industry

Title 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

Objective The aim of this study is to evaluate the ability of the experimental drug, Debio 1347, to control and fight cancer cells and to see if there is a response in terms of tumor reduction, when administered under the recommended dose. This dose was defined previously in patients with tumors similar to yours. The term experimental means that the drug is currently being tested and is not approved for sale in the United States by the Food and Drug Administration (FDA.)
You may know that a tumor starts to grow when the machinery of a normal cell becomes broken. This can occur when certain cell parts fuse together to form a completely new cell part. This is the case of your tumor: the molecule called FGFR fused with another molecule and this may be the reason for your cancers development. You have been invited to participate in this study because of this specific cancer development
The study drug Debio 1347 has been designed to block any abnormality of FGFR, including any fusion with other molecules. In doing so, the study drug may help cancer cells to die and therefore shrink the tumor(s). We have some preliminary evidences that Debio 1347 is active against tumors with FGFR fusions, however, more data is necessary to confirm the actual anti-tumor activity of this drug, which is why we are conducting this study
Other purposes of this study are to determine: if the drug is safe; if the drug has an effect on other targets; how the drug is broken down in your body; and to see if there are any molecular interactions that can help determine how Debio 1347 works. Since this drug has not been tested in human patients extensively, the risks and side effects of Debio 1347 are not fully known. Any side effect that you experience from taking this drug will be studied in an effort to make sure that this drug is safe to take

Treatment Debio 1347 will be provided to you in the form of 20 mg tablets. Each day you will have to swallow 4 tablets (which makes a total daily dose of 80 mg) as follows: In the early morning without having food (only water allowed) at least 4 hours before and 2 hours after Debio 1347 intake

Description Phase II Basket Study of Debio 1347 in Subjects with Solid Tumors with FGFR1, FGFR2 or FGFR3

Key Eligibility
  • Cytologically or histologically confirmed advanced solid tumor
  • 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
  • Male or female greater than or equal to 18 years of age
  • 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
  • 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 can 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
  • Measurable disease by RECIST 1.1
  • ECOG performance status 0-1
  • Adequate organ function as defined by the protocol
  • Male and Female patients of child bearing potential must agree to adequate birth control as defined by the protocol
  • Available fresh tumor sample (preferably) or, if no fresh sample can be obtained, archived tumor sample (slides or block) for central analysis of FGFR status or retrospective central confirmation in case of local screening
    EXCLUSION
  • Prior treatment with a FGFR1-3 selective inhibitor
  • 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
  • Current evidence of clinically significant corneal or retinal disorder confirmed by ophthalmologic examination
  • Chemotherapy or radiotherapy within 2 weeks prior to initial dosing with Debio 1347
  • Symptomatic or unstable brain metastases less than 1 month, Subjects with asymptomatic stable and treated brain metastases are eligible)
  • Total corrected and/or ionized serum calcium greater than or equal to 1.5 x UNL
  • Gastro-intestinal disorders that could affect drug absorption (including, but not limited to, gastric resection, significant bowel obstruction, active ulcerative colitis, active CrohnÂ’s disease)
  • Prolongation of QTcF interval to greater than 480 msec or history of congenital long QT syndrome
  • Known infection requiring the systemic use of an antibiotic or antiviral agent
  • Known contraindication to MRI and/or CT scan
  • Known history of uncontrolled or unstable angina or myocardial infarction, unstable cardiac arrhythmias despite treatment, unexplained recurrent syncope, family history of sudden death from cardiac-related causes, CHF greater than New York Heart Association (NYHA) class II, uncontrolled diabetes, uncontrolled psychiatric disorders, severe ongoing infections

  • Applicable Disease Sites Anal; Any Site; Bladder; Brain/Central Nervous System; Breast; Cervix; Colon and Rectum; Endocrine cancers; Esophagus; Gastrointestinal cancers, other; Genitourinary cancers, other; Head and Neck; Ill-Defined Sites; Kidney; Liver; Lung; Melanoma/Skin cancer; Ovary; Pancreas; Prostate; Sarcoma; Stomach; Thyroid; Unknown Sites; Uterus

    Status Open

    Participating Institutions UW Hospital and Clinics