EUCTR2018-003584-53-AT进行中（未招募）1 期
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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 125
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Written informed consent given according to ICH/GCP guidelines and local regulations.
- •2. Cytologically or histologically confirmed advanced solid tumor.
- •3. 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.
- •4. Male or female =18 years of age.
- •5. 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.
- •6. The subject must have received at least one prior line of standard therapy appropriate for tumor type and stage of disease (if available), and, in the opinion of the Investigator, s/he would have been unlikely to tolerate or derive clinically meaningful benefit from further appropriate standard of care therapy. In particular:
- •a. 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.
- •b. Urothelial cancer subjects must have progressed on/after cisplatin-based or carboplatinbased 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 subject).
- •c. 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).
- •d. For all other tumor types, subjects must have progressed on/after appropriate 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.
- •7. Measurable disease according to RECIST criteria version 1.1.
- •For further Inclusion Criteria please refer to the Protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 65
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1. History of hypersensitivity to any of the excipients in the Debio 1347 formulation.
- •2. Prior treatment with a FGFR1-3 selective inhibitor.
- •3. 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.
- •4. Current evidence of clinically significant corneal or retinal disorder confirmed by ophthalmologic examination.
- •5. Chemotherapy, radiotherapy or small molecule anti-cancer agents within 2 weeks prior to initial dosing with Debio 1347 (3 weeks for immune checkpoint inhibitors).
- •6. Administration of any investigational agent within 2 weeks prior to initial dosing with Debio 1347 (3 weeks for immune checkpoint inhibitors).
- •7. 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.
- •8. Grade > 1 NCI-CTCAE v5.0 AEs or toxicities from previous treatments except:
- •a. Albumin (= 2.5 g/dL is allowed).
- •b. AST and ALT in subjects with liver metastases.
- •c. ALP in subjects with bone metastases .
- •d. Any grade of alopecia is allowed.
- •e. Other Grade 1-2 clinically insignificant laboratory abnormalities are allowed.
- •For further Exclusion Criteria please refer to the Protocol.
研究者
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