NL-OMON56358招募中不适用
A Phase 1/2 Study of the Highly-selective RET Inhibitor, BLU-667, in Patients with Thyroid Cancer, Non-Small Cell Lung Cancer (NSCLC) and Other Advanced Solid Tumors - ARROW
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 23
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Patient is >= 18 years of age.
- •2. Diagnosis during dose escalation (Phase 1) - Pathologically
- •documented, definitively diagnosed non-resectable advanced solid
- •All patients treated at doses > 120 mg per day must have MTC, or a
- •RET-altered solid tumor per local assessment of tumor tissue and/or
- •Phase 1 enrichment patients must have MTC or a RET-altered solid
- •tumor per local assessment of tumor tissue and/or blood.
- •3. Diagnosis during dose expansion (Phase 2) - All patients (with the
- •exception of patients with MTC enrolled in Groups 3 and 4) must have an
- •oncogenic RET fusion or
- •mutation (excluding synonymous, frameshift, and nonsense mutations)
- •solid tumor, as determined by local testing of tumor or circulating tumor
- •nucleic acid in blood; as detailed below.
- •Group 1 - patients must have pathologically documented, definitively
- •diagnosed locally advanced or metastatic NSCLC with a RET fusion
- •previously treated with a platinum-based chemotherapy.
- •Group 2 - patients must have pathologically documented, definitively
- •diagnosed locally advanced or metastatic NSCLC with a RET fusion not
- •previously treated with a platinum-based chemotherapy, including those
- •who have not had any systemic therapy. Prior platinum chemotherapy in
- •the neoadjuvant and adjuvant setting is permitted if the last dose of
- •platinum was 4 months or more before the first dose of study drug.
- •Group 3 - patients must have pathologically documented, definitively
- •diagnosed advanced MTC that has progressed within 14 months prior to
- •the Screening Visit and was previously treated with cabozantinib and/or
- •vandetanib.
- •Group 4 - patients must have pathologically documented, definitively
- •diagnosed advanced MTC that has progressed within 14 months prior to
- •the Screening Visit and was not previously treated with cabozantinib or
- •vandetanib.
- •Group 5 - patients must have a pathologically documented, definitively
- •diagnosed advanced solid tumor with an oncogenic RET fusion, have previously
- •received SOC appropriate for their tumor type (unless there is no accepted
- •standard therapy for the tumor type or the investigator has determined that
- •treatment with standard therapy is not appropriate), and must not eligible for
- •any of the other groups.
- •Group 6 - patients must have a pathologically documented, definitively
- •diagnosed advanced solid tumor with an oncogenic RET fusion or
- •mutation, previously treated with a selective TKI that inhibits RET, such
- •as LOXO-292.
- •Group 7: patients must have a pathologically documented, definitively
- •diagnosed advanced solid tumor with an oncogenic RET mutation
- •previously treated with SOC appropriate for the tumor type and not
- •eligible for any of the other groups.
- •4. Patients must have non-resectable disease. Prior to protocol amendment 9,
- •must have progressed following standard therapy or have not
- •adequately responded to standard therapy, or the patient must be
- •intolerant to, or the Investigator has determined that treatment with
- •standard therapy is not appropriate, or there must be no accepted
- •standard therapy for their disease.
- 另有 4 项未显示
排除标准
- •1. Patient's cancer has a known primary driver alteration other than RET.
- •Investigators should discuss enrollment with Sponsor regarding comutations
- •2. Patient has any of the following within 14 d prior to the first dose of
- •a. Platelet count < 75 × 109/L
- •b. Absolute neutrophil count < 1.0 × 109/L
- •c. Hemoglobin < 9.0 g/dL red blood cell transfusion and erythropoietin
- •may be used to reach at least 9.0 g/dL, but must have been
- •administered at least 2 weeks prior to 1st IMP dose
- •d. AST or ALT > 3 × ULN if no hepatic metastases are present; > 5 × ULN
- •if hepatic metastases are present
- •e. Total bilirubin > 1.5 × ULN; > 3 × ULN with direct bilirubin > 1.5 ×
- •ULN in presence of Gilbert's disease
- •f. Estimated (Cockroft-Gault formula) or measured creatinine clearance
- •< 40 mL/min
- •g. Total serum phosphorous > 5.5 mg/dL
- •3. Patient has a QTcF > 470 msec. Patient has a history of prolonged QT
- •syndrome or Torsades de pointes. Patient has a familial history of
- •prolonged QT syndrome
- •4. Patient has clinically significant, uncontrolled, cardiovascular disease
- •including congestive heart failure Grade III or IV according to the New
- •York Heart Association classification; myocardial infarction or unstable
- •angina within the previous 6 months, uncontrolled hypertension, or
- •clinically significant, uncontrolled arrhythmias, including
- •bradyarrhythmias that may cause QT prolongation
- •5. Patient has CNS metastases or a primary CNS tumor associated with
- •progressive neurological symptoms or requires increasing doses of
- •corticosteroids to control the CNS disease. If a patient requires
- •corticosteroids for management of CNS disease, the dose must have
- •been stable for the 2 weeks preceding C1D1
- •6. Presence of clinically symptomatic interstitial lung disease or
- •interstitial pneumonitis, including radiation pneumonitis
- •7. Patient received the following anti-cancer therapy:
- •a. Any systemic anticancer therapy (except for immunotherapy or other
- •antibody therapies) and all forms of radiotherapy within 14 d or 5 halflives
- •prior to first IMP dose. IMP may be started within these washout
- •periods if considered by the Investigator to be safe and within the best
- •interest of the patient prior Sponsor approval
- •b. Any immunotherapy or other antibody therapy within 28 d prior to the
- •1st dose of IMP (immune related toxicities must have resolved to <
- •Grade 2 prior to starting IMP)
- •8. Dose expansion patients in Groups 1-5 and 7 (Phase 2): patient has
- •previously received treatment with a selective RET inhibitor such as
- •selpercatinib
- •9. Patient received neutrophil growth factor support within 14 d of 1st
- •10. Patient requires treatment with a prohibited medication or herbal remedy
- •that cannot be discontinued at least 2 weeks before start of IMP
- •administration. IMP may be started within 14 d or 5 half-lives of prior
- •therapy if considered by the Investigator to be safe and within the best
- •interest of the patient, with prior Sponsor approval
- •11. Patient has had a major surgical procedure within 14 d of the first
- 另有 5 项未显示
研究者
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