NL-OMON56219尚未招募3 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 177Lu-labelled somatostatin analogue (177Lu-SSA) therapy (ACTION-1) - RYZ101-301
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 12
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. Age of at least 18 years at the time of signing the informed consent.
- •2. Histologically proven, Grade 1-2 well differentiated, inoperable, advanced
- •3. Ki67 (mitotic) index <=20%.
- •4. Eastern Cooperative Oncology Group (ECOG) status 0-2.
- •5. Life expectancy of at least 12 weeks.
- •6. 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).
- •7. 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). Premature discontinuation of 177Lu-DOTATATE, 177Lu-DOTATOC, or
- •177Lu-HA- DOTATATE (i.e., 177Lu-SSA) treatment should not have been due to PD.
- •Dose reductions for
- •toxicity based on local labeling are allowed. No time limit is defined between
- •177Lu-SSA treatment and enrollment (Part 1)/randomization (Part 2). Other
- •anticancer treatments that do not meet exclusion criteria are allowed in this
- •interval. Subjects must have progressed on or after the last non-177Lu-SSA
- •anticancer treatment.
- •a. CT/MRI scan should be completed within 42 days (inclusive) prior to
- •enrollment (Part 1) or randomization (Part 2) and show disease progression
- •compared to a previous scan obtained at least 6 months following the last
- •177Lu-DOTATATE/TOC or 177Lu-HA- DOTATATE treatment (see Exclusion Criterion #1)
- •and within 18 months from screening (Figure 1-3). No non-SSA anticancer
- •treatment is permitted between the most recent scan used for eligibility
- •confirmation and the first dose of study treatment. A baseline CT/MRI scan must
- •always be obtained within 4 weeks (28 days) of the first dose of study
- •treatment for on-study response assessment (the most recent scan for
- •confirmation of progression may be used as the baseline scan if obtained prior
- •to enrollment/randomization and within 28 days of the first dose of study
- •treatment.)
- •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 90 days (inclusive) 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
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 drug
- •6. Use of anticancer agents within the following intervals prior to the first
- •dose of study drug: 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 <7 days or <5 half-lives 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 drug 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 a persistent fasting
- •glucose >2 x ULN 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 de
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