JPRN-jRCT2080225176已完成1 期
A PHASE 1, OPEN-LABEL, DOSE-FINDING STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PRELIMINARY EFFICACY OF CC-90010 IN SUBJECTS WITH ADVANCED SOLID TUMORS AND RELAPSED/REFRACTORY NONHODGKIN LYMPHOMAS
Bristol-Myers Squibb0 个研究点目标入组 6 人开始时间: 2020年4月24日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Men and women >= 18 years of age, at the time of signing the informed consent document (ICD). For the Japanese Cohort, a signed ICD must be obtained from the subject and the subjects legal representative if the subject is under 20 years old. Once a subject who is a minor reaches the age of 20, then reconsent must be obtained from the subject at that point.
- •2. Subjects with histological or cytological confirmation of either
- •a. In Part A, advanced or unresectable solid tumors or advanced relapsed and/or refractory NHL (ie, DLBCL and FL or MZL) including those who have progressed on (or not been able to tolerate due to medical comorbidities or unacceptable toxicity) standard anticancer therapy or for whom no other approved conventional therapy exists.
- •b. In Part B dose expansion,
- •- Cohorts 1, 3 and the Japanese Cohort: relapsed and/or refractory DLBCL following at least 2 prior lines of therapy (e.g. have failed at least one line of standard therapy and have received at least one prior line of salvage therapy) OR have failed at least one prior line of standard therapy and are not eligible for autologous stem cell transplant (ASCT) or have declined ASCT; transformed lymphoma following chemotherapy for lower grade lymphoma and at least two standard treatment regimen for DLBCL.
- •- Subjects with two or more lines of systemic therapy must have been treated with and have lack of response after chimeric antigen receptor (CAR) T-cell therapy, if such therapy is available, OR be ineligible for CAR T-cell therapy at the time of enrollment, OR subject declined CAR T-cell therapy.
- •- Japanese Cohort: advanced or unresectable solid tumors including those who have progressed on (or not been able to tolerate due to medical comorbidities or uncceptable toxicity) standard anticancer therapy or for whom no other approved conventional therapy exists.
- •- Cohort 2: advanced basal cell carcinoma including those who have progressed on (or not been able to tolerate due to medical comorbidities or unacceptable toxicity) standard anticancer therapy or for whom no other approved conventional therapy exists.
- •c. In Part C, advanced or unresectable solid tumors including those who have progressed on (or not been able to tolerate due to medical comorbidities or unacceptable toxicity) standard anticancer therapy or for whom no other approved conventional therapy exists.
- •3. At least one site of measurable disease according to RECIST 1.1 (Eisenhauer, 2009) for subjects with solid tumors: bi-dimensionally measurable disease on cross sectional imaging by CT or MRI, with at least one lesion >1.5 cm in its greatest transverse diameter, as defined by the IWG criteria (Cheson, 2014) for subjects with NHL. For subjects with rare malignancies, not falling into the above categories and who might benefit from a treatment with BET inhibitor, evaluable disease can be considered.
- •4. Tumor biopsies whenever safe and feasible will be collected in Part A, except for subjects with GBM. Subject consents to mandatory tumor biopsies (Screening and on treatment) in Part B, except for the Japanese Cohort. In exceptional circumstances an exemption waiver may be granted by the Sponsor for this criterion.
- •5. ECOG PS of 0 to 1.
- •6. Females of childbearing potential (FCBP)1 must:
- •- Either commit to true abstinence2 from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with, at least two effective contraceptive methods (oral
排除标准
- •1. Subject has received anti-cancer therapy (either approved or investigational) within =< 4 weeks or 5 half-lives, whichever is shorter, prior to starting CC-90010.
- •2. Subject has received prior CAR T-cell therapy or other T-cell targeting treatment (approved or investigational) =< 4 weeks prior to starting CC-90010.
- •3. Toxicities resulting from prior systemic cancer therapies must have resolved to =< NCI CTCAE Grade 1 prior to starting CC-90010 treatment (with exception of grade 2 peripheral neuropathy and alopecia).
- •4. Subject has received autologous hematologic stem cell transplant (HSCT) =<3 months prior to starting CC-90010 treatment. Subjects with allogeneic HSCT will not be allowed on this protocol.
- •5. Subject has undergone major surgery =< 4 weeks or minor surgery =< 2 weeks prior to starting CC-90010 or who have not recovered from surgery.
- •6. Subject has completed any radiation treatment < 4 weeks prior to starting CC-90010
- •7. Symptomatic, untreated, or unstable central nervous system (CNS) metastases.
- •8. Known symptomatic acute or chronic pancreatitis.
- •9. Impaired cardiac function or clinically significant cardiac diseases
- •10. Pregnant or nursing females.
- •11. History of concurrent second cancers requiring active, ongoing systemic treatment.
- •12. Subjects with a history of clinically significant cognitive disorder(s) or active cognitive disorder(s).
- •13. Evidence of history of bleeding diathesis.
- •14. Subjects with known prior episodes of non-arteritic anterior ischemic optic neuropathy (NAION) should be excluded from the study. CC-90010 should be used with caution in subjects with retinitis pigmentosa.
- •15. Subject has any significant medical condition (eg, active or uncontrolled infection or renal disease), laboratory abnormality, or psychiatric illness that would prevent the subject from participating (or compromise compliance) in the study or would place the subject at unacceptable risk if he/she were to participate in the study. Subjects with a history or complication of interstitial lung disease. Subjects with hypersensitivity to the active ingredient and/or the excipients of the study drug.
- •16. Patients with poor bone marrow reserve as assessed by the Investigator such as in the following conditions
- •- Having received extensive bone radiotherapy
- •- Having experienced several episodes of bone marrow aplasia in previous treatments
- •- Confirmed histological bone marrow cancer infiltration (with exemption of NHL)
- •- Requiring regular hematopoietic support (blood transfusion, erythropoietin, GCSF)
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