EUCTR2020-004383-25-CZ进行中（未招募）1 期
A Phase I/Ib, open-label, multi-center study of DFF332 as a single agent and in combination with Everolimus or IO agents in patients with advanced/relapsed ccRCC and other malignancies with HIF2alpha stabilizing mutations.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 187
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
- •For dose escalation and expansion arms on SA and combos, with the exception of Arm1B:
- •1. Male and female = 18 years of age
- •2. Histologically confirmed and documented clear cell renal cell carcinoma (ccRCC). Disease must be measureable as determined by RECIST v1.1.
- •3. Patient with unresectable, locally advanced or metastatic ccRCC with documented disease progression following therapy with PD-1/L1 checkpoint inhibitor and a VEGF targeted therapy as monotherapy or in combination.
- •Escalation: No restriction on the number of prior treatments
- •Expansion: Up to 3 prior lines of treatment for advanced/metastatic disease
- •4. ECOG performance status = 1
- •For basket arm (Arm 1B):
- •1. Male and female of age = 12 years of age.
- •2. Histologically confirmed and documented malignancies in the context of the following cancer predisposing syndromes/disorders or harboring somatic mutations on one of these genes:
- •Malignancies with VHL mutations (e.g. Von Hippel-Lindau disease)
- •Malignancies with FH mutations (e.g. Hereditary leiomyomatosis and renal cell carcinoma)
- •Malignancies with mutations in SDHD, SDHAF2, SDHC, SDHB, SDHA (e.g. Hereditary paraganglioma and pheochromocytoma syndrome)
- •Malignancies with EPAS1/HIF2A mutations
- •Malignancies with ELOC/TCEB1 mutations
- •3. Patients must have either metastatic disease or locally advanced disease that is unresectable or that patients be unfit for resection or other treatment modalities. Patients must have received prior standard therapy appropriate for their tumor type and stage of disease, and have no available therapies of proven clinical benefit; or in the opinion of the investigator, would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy.
- •4. For patients age = 16 years: ECOG performance status = 1
- •For patients age = 12 and < 16 years: Lansky performance status = 70
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 7
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •1. Symptomatic or uncontrolled brain metastases requiring concurrent treatment, inclusive of but limited to surgery, radiation and/or corticosteroids. Patients with treated symptomatic brain metastases should be neurologically stable for 4 weeks post-treatment prior to study entry and at doses = 10 mg per day prednisone or equivalent for at least 2 weeks before administration of any study treatment.
- •2. History of seizure disorder and/or extrapyramidal symptoms.
- •3. Known additional malignancy that is progressing or requires active treatment within the past 3 year(s). Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer or other tumors that will not affect life expectancy.
- •4. Patients having out of range lab values during screening and before the first dose of study treatment. Out of range lab values are defined as:
- •5. Absolute neutrophil count (ANC) <1.0 × 109/L
- •6. Platelets <75 × 109/L
- •7. Hemoglobin (Hgb) < 10g/dL
- •8. Serum creatinine > 1.5 × ULN or creatinine clearance < 60mL/min using Cockcroft-Gault formula
- •9. Total bilirubin > 1.5 × ULN , except for patients with Gilbert’s syndrome > 3.0 × ULN or direct bilirubin > 1.5 × ULN
- •10. Aspartate aminotransferase (AST) > 3 × ULN
- •11. Alanine aminotransferase (ALT) > 3 × ULN
- •12. Serum electrolytes = grade 2 despite adequate supplementation.
- •13. Treatment with any of the following anti-cancer therapies prior to the first dose of study treatment within the stated timeframes:
- •14. = 4 weeks for radiation therapy or limited field radiation for palliation within = 2 weeks prior to the first dose of study treatment.
- •15. = 4 weeks or = 5 half-lives (whichever is shorter) for chemotherapy or biological therapy (including monoclonal antibodies) or continuous or intermittent small molecule therapeutics or any other investigational agent.
- •16. = 6 weeks for cytotoxic agents with major delayed toxicities, such as nitrosourea and mitomycin C.
- •17. = 4 weeks for immuno-oncologic therapy, such as CTLA-4, PD-1, or PD-L1 antagonists.
- •18. Patients who have undergone major surgery = 4 weeks prior to first dose of study treatment or who have not recovered for the surgical procedure.
- •19. 5. Patient previously treated with a HIF2a inhibitor.
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