EUCTR2016-002017-22-PL进行中（未招募）1 期
A First-in-Human, Open-label, Phase 1/2 Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Subjects with Advanced Cancers
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 215
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. = 18 years of age
- •2. Have evaluable disease,
- •2a. For Part 2, at least 1 measurable lesion that can be accurately
- •assessed at baseline by CT (or magnetic resonance imaging [MRI] where
- •CT is contraindicated) and is suitable for repeated assessment as per
- •RECIST v1.1
- •3.1. Criterion modified per Amendment 2
- •3.2. Criterion modified per Amendment 3
- •3.3. Type of cancer:
- •Part 1 of the study:
- •Has any type of advanced or refractory solid tumor malignancy, except
- •lymphoma, that is metastatic or unresectable and previously received or
- •was ineligible for standard treatment options including appropriate
- •molecularly targeted therapies (eg, subjects with epidermal growth
- •factor receptor [EGFR] mutant NSCLC or with NSCLC with anaplastic
- •lymphoma tyrosine kinase [ALK] rearrangement).
- •Part 2 of the study:
- •Histologically or cytologically confirmed diagnosis of 1 of the following
- •unresectable Stage III or IV solid tumor malignancies and previously
- •received or was ineligible for standard treatment options including
- •appropriate molecularly targeted therapies (eg, subjects with EGFR
- •mutant NSCLC or with NSCLC with ALK rearrangement):
- •- PD-L1-high tumor sample (=50% tumor cells stained positive for PDL1)
- •by a PD-L1 immunohistochemistry (IHC) test performed by a local
- •laboratory or by the central laboratory designated by the sponsor
- •NOTE: Subjects with EGFR mutant or other molecular aberration who
- •progress on appropriate molecular targeted therapy do not require prior
- •treatment with platinum-containing chemotherapy.
- •Bladder cancer (urothelial carcinoma)
- •Renal cell carcinoma
- •Gastric/esophageal carcinoma
- •MSI-H or dMMR CRC
- •- MSI-H or dMMR by a polymerase chain reaction (PCR), next
- •generation sequencing, or IHC test performed by a local laboratory or by
- •the central laboratory designated by the sponsor Progressed following
- •treatment with a fluoropyrimidine, oxaliplatin, and irinotecan
- •Thymoma, including thymic carcinoma
- •4. Have an Eastern Cooperative Oncology Group [ECOG] performance
- •status 0 or 1 (Attachment 1)
- •5.1. Criterion modified per Amendment 2
- •5.2. Have organ and bone marrow function as follows without blood
- •6. Criterion modified per Amendment 2
- •6.1. Has thyroid function laboratory values within normal range. Note: If
- •thyroid stimulating hormone (TSH) is not within normal limits, the
- •subject may still be eligible if T3 (either total or free) and free T4 are
- •within normal limits.
- •7. Women of childbearing potential must have a negative serum
- •pregnancy test at Screening using highly sensitive pregnancy test.
- •8. Willing to use contraceptive methods consistent with local regulations
- •for subjects participating in clinical studies during and after the study
- 另有 12 项未显示
排除标准
- •1. Has uncontrolled intercurrent illness, including but not limited to
- •ongoing or active infection requiring IV antibiotics, symptomatic
- •congestive heart failure (New York Heart Association class III-IV;
- •Attachment 2), unstable angina pectoris, cardiac arrhythmia, poorly
- •controlled hypertension or diabetes, or psychiatric illness/social
- •situation that would limited compliance with study requirements
- •2. Has had prior treatment with an anti-PD-1 antibody, anti-PD-L1
- •antibody or anti-PD-L2 antibody
- •3. Treatment with any local or systemic anti-neoplastic therapy,
- •radiotherapy (excluding limited palliative radiation), or investigational
- •anticancer agent within 14 days or 4 half-lives, whichever is longer, up
- •to a maximum wash-out period of 28 days prior to the initiation of study
- •drug administration.
- •4. Criterion modified per Amendment 2
- •4.1. Has brain or leptomeningeal metastases unless asymptomatic, have
- •been treated, have been stable for >4 weeks as documented by
- •radiographic imaging with no evidence of cavitation or hemorrhage in
- •the brain lesion, and do not require prolonged (>2 weeks) systemic
- •corticosteroid therapy. Subjects are not permitted to receive enzymeinducing
- •antiepileptic drugs.
- •5. Has not recovered (ie, =Grade 1 or baseline) from AEs except
- •alopecia, peripheral neuropathy related to prior anticancer therapy and
- •stable anemia (ie, untransfused Hb =8.5 g/dL without the need for
- •supportive transfusion within 2 weeks of screening) at the time of
- •treatment allocation
- •6. Criterion modified per Amendment 2
- •6.1. Has an active autoimmune disease or a documented history of
- •autoimmune disease that requires systemic steroids or
- •immunosuppressive agents. Note: Subjects with vitiligo or resolved
- •childhood asthma/atopy would be an exception to this rule. Subjects
- •that require intermittent use of bronchodilators or local steroid
- •injections would not be excluded from the study. Subjects with
- •hypothyroidism stable on hormone replacement will not be excluded
- •from the study. Subjects with a history of transient autoimmune
- •manifestations of an acute infectious disease that resolved upon
- •treatment of the infectious agent (eg, acute Lyme arthritis) will not be
- •excluded from the study.
- •7. Grade 3 or higher toxicity effects from previous treatment with
- •immunotherapy
- •8. Known allergies, hypersensitivity, or intolerance to protein-based
- •therapies or with a history of any significant drug allergy (such as
- •anaphylaxis, hepatotoxicity, or immune-mediated thrombocytopenia or
- •anemia), or to JNJ-63723283 excipients (refer to Investigator's
- •9. Has taken immunosuppressive doses of systemic medications such as
- •corticosteroids (doses >10 mg/day prednisone or equivalent), within 2
- •weeks before the planned first dose of study drug
- •10. A woman who is pregnant, breast-feeding, or planning to become
- •pregnant while enrolled in this study or within 5 months after the last
- •dose of study drug
- •11. A man who plans to father a child while enrolled in this study or
- 另有 8 项未显示
研究者
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