EUCTR2022-000507-12-NL进行中（未招募）1 期
Phase 1b/3 global, randomized, controlled, open-label trial comparing treatment with RYZ101 to standard of care (SoC) therapy in subjects with inoperable, advanced, somatostatin receptor expressing (SSTR+), well-differentiated gastro-enteropancreatic neuroendocrine tumors (GEP-NETs) that have progressed following prior treatment with 177Lu-labelled somatostatin analogue (177Lu-SSA) therapy (ACTION-1) - ACTION-1
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
- 288
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
- 性别
- All
入选标准
- •1. Histologically proven, Grade 1-2 well differentiated, inoperable, advanced GEP-NETs.
- •2. Ki67 (mitotic) index =20%.
- •3. Eastern Cooperative Oncology Group (ECOG) status 0-2.
- •4. Life expectancy of at least 12 weeks.
- •5. Subjects with functional tumors who are receiving octreotide LAR or lanreotide for symptom control must be on a stable dose for at least 12 weeks prior to enrollment (Part 1) or randomization (Part 2).
- •a. Subjects with nonfunctional tumors or functional tumors that do not require octreotide LAR or lanreotide for symptom control must discontinue octreotide LAR or lanreotide at least 4 weeks prior to enrollment (Part 1) or randomization (Part 2).
- •6. Progressive GEP-NET (GI or pancreas) based on RECIST v1.1 following a minimum of 2 cycles and a maximum of 4 cycles of treatment with 177Lu-DOTATATE (7.4 GBq ±10% each cycle), or a total cumulative dose of up to 29.6 GBq ±10%), 177Lu-DOTATOC (7.5 GBq ±10% each cycle), or a total cumulative dose of up to 30 GBq ±10%), or 177Lu-HA-DOTATATE
- •(7.4 GBq ±10% each cycle). or a total cumulative dose of up to 29.6 GBq ±10%). Radiographic progression must be demonstrated within 18 months from enrollment (Part 1) or randomization (Part 2).
- •a. CT/MRI scan should be completed within 90 days (inclusive) prior to enrollment (Part 1) or randomization (Part 2) and show disease progression compared to the previous scan obtained at least 6 months following the last 177Lu-DOTATATE/TOC or 177Lu-HA-DOTATATE treatment (see Exclusion Criterion #1).
- •b. For subjects on octreotide LAR or lanreotide, progression should be documented while the subject was on a fixed dose of octreotide LAR or lanreotide.
- •c. There must be at least 1 SSTR-PET imaging-positive (using a regulatory agency-approved imaging method, e.g., 68Gallium [68Ga] or 64Copper [64Cu]-based), measurable site of disease (according to RECIST v1.1) and no RECIST v1.1 measurable metastatic lesions that are SSTR imaging -negative. Assessment of SSTR expression must be within 3 months prior to enrollment (Part 1) or randomization (Part 2) without any intervening non-SSA anticancer treatments for GEP-NET.
- •d. Tumor uptake observed in each RECIST v1.1 measurable lesion using a regulatory agency -approved SSTR-PET imaging method must be greater than the liver uptake observed on regulatory agency-approved SSTR-PET imaging, to be centrally confirmed in Part 2.
- •7. Part 2: Subject is a candidate for therapy with 1 of the following SoC options:
- •a. Everolimus 10 mg daily by mouth
- •b. Sunitinib 37.5 mg daily by mouth
- •c. High-dose octreotide LAR 60 mg Q4W by intramuscular (i.m.) injection
- •d. High dose frequency lanreotide 120 mg every 2 weeks (Q2W) by deep subcutaneous (s.c.) injection.
- •8. Adequate renal function, as evidenced by creatinine clearance (CrCl) =60 mL/min (calculated using the Cockcroft-Gault formula)
- •9. Adequate hematologic function, defined by the following laboratory results:
- •a. Part 1: Hemoglobin concentration =5.6 mmol/L (=9.0 g/dL); absolute neutrophil count (ANC) =1500 cells/µL (=1500 cells/mm3); platelets =100 x 109/L (100 x 103/mm3)
- •b. Part 2: Hemoglobin concentration =5.0 mmol/L (=8.0 g/dL); ANC =1000 cells/µL (=1000 cells/mm3); platelets >100x 109/L (100 x 103/mm3).
- •10. Total bilirubin =3 x upper limit normal (ULN)
- •11. Serum albumin =3.0 g/dL unless prothrombin time (PT) is within the normal range
- •12. For women of childbearing potential (WOCBP):
- •a. Negative serum pregnancy test within 48 hours prior to the first dose of study treatme
排除标准
- •1. Subjects with a GEP-NET deemed nonresponsive to PRRT, defined as no disease control (PR, CR, or SD) achieved for at least 6 months following the last dose of prior 177Lu-DOTATATE/TOC or 177Lu-HA-DOTATATE treatment.
- •2. Known hypersensitivity to 225Actinium, 68Gallium, 64Copper, octreotate, or any of the excipients of DOTATATE imaging agents
- •3. Part 1: Prior treatment with alkylating agents
- •4. Prior radioembolization
- •5. Any surgery, chemoembolization, and radiofrequency ablation within 12 weeks prior to first dose of study treatment
- •6. Use of anticancer agents within the following intervals prior to the first dose of study treatment:
- •a. PRRT: within < 6 months (177Lu-DOTATATE/TOC or 177Lu-HA-DOTATATE only, as described in Inclusion Criterion #7)
- •b. Chemotherapy: within <6 weeks
- •c. Small molecule inhibitors: within <4 weeks
- •d. Biological agents: within 4 weeks
- •7. Prior radiation therapy as defined below:
- •a. Part 1: Any prior external beam radiation therapy, including stereotactic body radiation therapy (SBRT)
- •b. Part 2: Any of the following:
- •i. Radiation therapy within 6 weeks prior to study enrollment
- •ii. Prior external beam radiation therapy to more than 25% of the bone marrow
- •8. Prior participation in any interventional clinical study within 30 days prior to first dose of study treatment
- •9. Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study
- •10. Significant cardiovascular disease, such as New York Heart Association (NYHA) Class =II heart failure
- •a. Subjects with a known left ventricular ejection fraction (LVEF) <40% will be excluded.
- •b. Subjects with known coronary artery disease, congestive heart failure not meeting the above criteria, or LVEF <50% must be on a stable medical regimen that is optimized in the opinion of the treating physician.
- •c. QT interval corrected for heart rate using Fridericia’s formula (QTcF) >470 ms for females and >450 ms for males, demonstrated by the average value of 3 consecutive ECGs
- •11. Resistant hypertension, defined as persistent uncontrolled blood pressure (BP) >140/90 mmHg while on optimal doses of at least 3 antihypertensive medications with 1 being a diuretic. Patients with baseline hypertension may be eligible after initiation of antihypertensive therapy.
- •12. Uncontrolled diabetes mellitus as defined by hemoglobin A1C (HgB A1C) =8%
- •13. Have a history of primary malignancy within the past 3 years other than (1) GEP-NET, (2) adequately treated carcinoma in situ or non-melanoma carcinoma of the skin, (3) any other curatively treated malignancy that is not expected to require treatment for recurrence during participation in the study, or (4) an untreated cancer on active surveillance that may not affect the subject’s survival status for =3 years based on clinician assessment/statement and with Medical Monitor approval.
- •14. Known brain, meningeal or spinal cord metastases. In Part 2, subjects with previously treated brain metastases will be allowed if the following conditions are met: (a) there is no evidence of central nervous system (CNS) progression for at least 6 months as assessed by local MRI for brain metastasis during screening; (b) the subject has recovered from acute side effects of radiotherapy; and (c) the subject is receiving a stable or decreasing dose of steroids.
- •15. For subjects with functional tumors that require treatment with SSAs for symptom control:
- •a. Any subject receiving treatment with short acting octreotide,
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