NL-OMON55159已完成2 期
A Phase 1/2 Study of ALKS 4230 Administered Subcutaneously as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors - ARTISTRY-2 (001) - A phase 1/2 Study of ALKS 4230 in Subjects with Solid Tumors.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
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. Subject is aged >=18 years.
- •2. Subject or the subject*s legal representative provides written informed
- •3. For Phase 1, subject must have an advanced solid tumor and progressive
- •disease following at least one line of therapy.
- •4. For Phase 2, subject must have one of the following tumor types or specific
- •SCCHN cohort: subjects with regionally advanced and/or distantly metastatic
- •head and neck squamous cell carcinoma of non-cutaneous origin that has relapsed
- •or failed to achieve complete response after at least one line of systemic
- •therapy given alone or in combination with surgery and /or radiation therapy,
- •and that has failed to achieve complete response or relapsed after (or subject
- •has become intolerant to) CPI (given alone or in combination with other
- •agents), and that is presently considered inoperable and unamenable to (re-)
- •irradiation.
- •Gastric/GEJ cohort: subjects with unresectable metastatic or locally advanced
- •or GEJ adenocarcinoma who have not been previously treated with immune CPIs
- •(anti-PD-1, anti-PD-L1, anti-CTLA-4) and who have progressed on and/or after two
- •prior regimens. Prior regimens had to have included a fluoropyrimidine and a
- •platinum chemotherapy. Progression within 6 months of prior adjuvant or
- •neoadjuvant chemotherapy will be deemed a rapid progressor and thus equivalent
- •one advanced/metastatic disease treatment regimen. Changing from IV to oral
- •fluoropyrimidine without noted progression is considered only one prior regimen.
- •Her2 positive patients must have received prior anti-Her2 therapy and
- •demonstrate
- •progressive disease. PD-L1 status must be known at the time of enrollment based
- •an approved test. If PD-L1 status is unknown during Screening, tumor tissue
- •biopsy or archived samples) must be tested for PD-L1 expression prior to
- •enrollment. Patients with known MSI-high/dMMR status are not eligible.
- •Ovarian cancer cohort: subjects must have recurrent high-grade serous,
- •endometrioid, or clear cell ovarian, fallopian tube, or primary peritoneal
- •cancer. Subject must have experienced a response lasting at least 3 months to
- •first-line platinum-based therapy but must be considered resistant to the last
- •administered platinum containing therapeutic regimen. Subjects must have
- •received prior monoclonal antibody that inhibits angiogenesis (e.g.,
- •bevacizumab) either as single agent or in combination or be deemed ineligible
- •or intolerant. Subject with a known BRCA-1 or -2 mutation must have received
- •prior poly ADP ribose polymerase (PARP) inhibitor. Subject must not have
- •received prior checkpoint inhibitor therapy.
- •5. Subject must have at least one target lesion based on RECIST.
- •6. Subject has an Eastern Cooperative Oncology Group Performance Status (ECOG
- •PS) score of 0 or 1 and an estimated life expectancy of at least 3 months.
- •7. Subject has adequate hematologic reserves, measured within 7 days prior to
- •start of study treatment, as evidenced by:
- •Absolute neutrophil count of >=1000/µL,
- •Absolute lymphocyte count of >=500/µL,
- •Platelet count of >=75,000/µL, and
- •Hemoglobin of >=9 g/dL (subjects may be transfused to this level if necessary).
- •8. Subject has adequate hepatic function as evidenced by aspartate transaminase
- •and alanine aminotransferase values <=3 × the upper limit of norm
排除标准
- •1. Subject is currently pregnant or breastfeeding or is planning to become
- •pregnant during the study period.
- •2. Subjects who are investigational site staff members directly involved in the
- •conduct of the trial and their immediate family members, site staff members
- •otherwise supervised by the Investigator, or subjects who are Alkermes or
- •Syneos Health employees directly involved in the conduct of the study
- •(immediate family is defined as a spouse, parent, child, or sibling, whether
- •biological or legally adopted).
- •3. Subject has an active infection or a fever >=38.5°C (>=101°F) within 3 days of
- •the first scheduled day of dosing for the monotherapy lead-in of Phase 1 or
- •Cycle 1 of Phase 2.
- •4. Subjects who have received therapeutic systemic antibiotics within 14 days
- •prior to starting investigational therapy excluded unless specifically exempted
- •on a case-by-case basis by the Medical Monitor. Antibiotics given for
- •peri-procedural prophylaxis or given presumptively for a limited time (e.g.,
- •until infection was ruled out), as well as topical or intra-ocular antibiotics,
- •shall not be exclusionary.
- •5. Subject has known hypersensitivity (Grade >=3) to any components of ALKS
- •4230, to pembrolizumab, or any of its excipients.
- •6. Subjects with mean QT interval corrected by the Fridericia Correction
- •Formula values of >470 msec (in females) or >450 msec (in males) following a
- •standard 12-lead electrocardiogram (ECG); subjects who are known to have
- •congenital prolonged QT syndromes; or subjects who are on medications known to
- •cause prolonged QT interval on ECG.
- •7. Subject has developed Grade >=3 autoimmune disorders while on prior
- •immunotherapy, (e.g., pneumonitis, nephritis, and neuropathy). Subjects who
- •have immune-mediated endocrinopathies and are stable on hormone replacement
- •therapy are not excluded. Subjects who developed other autoimmune disorders of
- •Grade <=2 may enroll if the disorder has resolved and the subject is off
- •systemic steroids for >=28 days. Subjects who experienced autoimmune colitis as
- •a toxicity of prior immunotherapy must undergo colonoscopy to rule out ongoing
- •inflammation. Vitiligo is not exclusionary.
- •8. Subjects who have received radiotherapy within the last 4 weeks before start
- •of study treatment, with the exception of limited field palliative radiotherapy
- •that has been completed at least 2 weeks before starting study treatment.
- •9. Subject has active or symptomatic central nervous system metastases unless
- •the metastases have been treated by surgery and/or radiation therapy, and/or
- •gamma knife, the subject has been tapered to a dose of 10 mg of prednisone (or
- •equivalent) or less of corticosteroids for at least 2 weeks before the first
- •dose of study agent(s), and the subject is neurologically stable.Patients with
- •history of brain metastases or a suspicion of brain metastases must have a
- •brain magnetic resonance imaging (MRI) at baseline.
- •10. Subject has an active autoimmune disease that has required systemic
- •treatment within the past 3 months or a documented history of clinically severe
- •autoimmune disease that has required systemic steroids and/or immunosuppressive
- •agents. Limited exceptions may be granted on a case-by-case basis by the
- •Medical Monitor. Replacement therapy (eg, thyroxine, insulin, or physiologic
- •corticosteroid replacement therapy
研究者
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