NL-OMON54060尚未招募2 期
A Phase IIB, Open Label, Study of Zirconium Zr 89 Crefmirlimab Berdoxam PET-CT in Subjects with Selected Advanced or Metastatic Malignancies including Melanoma, Merkel Cell, Renal Cell and Non-Small Cell Lung Cancers, Scheduled to Receive Standard-of-Care Immunotherapy (IOT) as a Single Agent or Combination, to Predict Response to Therapy - iPREDICT
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
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. Subjects must meet either 1a,1b or 1c:
- •1a. For enrollment into Cohort A: Subjects with histologically confirmed
- •advanced or metastatic non-uveal/non-mucosal melanoma or Merkel cell carcinoma
- •(MCPyV positive and negative) who are not amenable to surgical cure and are
- •candidates to receive single- or combined IOT alone (not to include cytotoxic
- •chemotherapy) as first or second line treatment as per the local
- •label/prescribing information at the physicians discretion.
- •1b. For enrollment into Cohort B: Subjects with histologically confirmed
- •advanced or metastatic clear cell Renal Cell Carcinoma or Renal Cell Carcinoma
- •with sarcomatoid features (regardless of subtype) as defined on pathologic
- •examination by a component of clear cell or sarcomatoid, who are not amenable
- •to surgical cure and are candidates to receive single- or combined IOT alone or
- •IOT in combination with VEGFR-directed or tyrosine kinase inhibitor (not to
- •include cytotoxic chemotherapy) as first or second line treatment as per the
- •local label/prescribing information at the physicians discretion.
- •c. For enrollment into Cohort C: Subjects with histologically confirmed
- •advanced or metastatic non-small cell lung cancer without non-smokers/driver
- •mutations who are not amenable to surgical cure, and are candidates to receive
- •single- or combined IOT alone (not to include cytotoxic chemotherapy) as first
- •or second line treatment as per the label/prescribing information at the
- •physicians discretion.
- •i. Patients with driver mutations that are expected to show significant
- •benefit from first line checkpoint inhibiter treatment (such as KRAS G12C
- •mutations) are eligible if all other I/E criteria are met.
- •2. At least 1 RECIST 1.1-measurable, non-irradiated, non-osseous (unless there
- •is an associated measurable soft-tissue component) lesion documented on
- •intravenous (IV) contrast-enhanced CT or MRI (per RECIST criteria 1.1) prior to
- •first zirconium Zr 89 crefmirlimab berdoxam administration.
- •3. Has had an adequate amount of time between their prior treatment/procedure
- •and the 1st administration of zirconium Zr 89 crefmirlimab berdoxam
- •4. Eastern Cooperative Oncology Group (ECOG) performance status <= 2 and
- •anticipated survival of at least 6 months.
- •5. Male or female, age >= 18 years.
- •Additional inclusion criterion for iTOX addendum: SOC treatment should be a
- •combination of ipilimumab and nivolumab.
排除标准
- •Subjects will NOT be eligible for enrollment in the study if they meet ANY of
- •the following criteria:
- •1. Bone-only disease without a measurable soft tissue component on conventional
- •imaging (MRI, PET, CT).
- •2. Subjects with skin-only (cutaneous) lesions will be excluded from the tumor
- •biopsy assessment.
- •3. Serious nonmalignant disease or conditions that in the opinion of the
- •investigator and/or ImaginAb could compromise the safety of the subject or the
- •protocol objectives.
- •4. Subjects with splenic dysfunction or who are status post splenectomy.
- •Post-splenectomy subjects who develop an accessory spleen with clinical and
- •radiographic evidence of splenic function will be allowed with prior approval
- •from the Sponsor.
- •5. Corticosteroid therapy is prohibited if used for the treatment of
- •inflammatory or autoimmune conditions. Patients with adrenal insufficiency
- •from prior surgery or immunotherapy toxicity may be on standard chronic
- •replacement doses of hydrocortisone that also require sporadic use of stress
- •doses of steroid .
- •6. Pregnant women or nursing mothers.
- •Additional exclusion criteria apply for patients to be eligible for the iTOX
- •1. Clinically active auto-immune disease, active infection or chronic
- •inflammatory disease.
- •2. Course of antibiotics within 4 weeks prior to ICF signing.
研究者
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