EUCTR2020-000848-57-DK进行中（未招募）1 期
A Phase 1b/2, Open-Label, Safety and Efficacy Study of Epcoritamab (GEN3013; DuoBody®-CD3 X CD20) in Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Genmab A/S
- 入组人数
- 171
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
- •All Subjects
- •Subject must sign an ICF, prior to any Screening procedures
- •Must be at least 18 years of age
- •ECOG performance status score of 0,1 or 2
- •Evidence of CD20 positivity in a sample representative of the disease (eg, tumor biopsy/peripheral blood/bone arrow) at Screening
- •Has acceptable laboratory parameters
- •A woman with reproductive potential must agree to use adequate
- •contraception during the trial, and for 12 months after the last
- •administration of epcoritamab.
- •A woman of childbearing potential must have a negative serum (betahCG) pregnancy test at Screening and a negative serum or urine
- •pregnancy test before treatment administration on Day 1 of every cycle.
- •A woman must agree not to donate eggs (ova, oocytes) for the
- •purposes of assisted reproduction during the entire trial, until 12 months
- •after last treatment.
- •A man who is sexually active with a woman of childbearing potential
- •and has not had a vasectomy must agree to use a barrier method of birth
- •Inclusion Criteria Specific to Subjects With R/R CLL– Dose Escalation
- •Monotherapy (All Cohorts) and Expansion Monotherapy (Arm 1)
- •Must have active CLL/SLL disease that needs treatment.
- •R/R CLL after receiving at least 2 prior lines of therapy.
- •Diagnosis of CLL/SLL that meets published diagnostic criteria (Hallek
- •et al., 2018a)
- •Must take prophylaxis for TLS
- •Inclusion Criteria Specific to Subjects With Richter's Syndrome –
- •Expansion Monotherapy Arm 2A
- •Must have measurable disease as determined by FDG- PET CT and a CT
- •scan (or MRI)
- •Must provide a mandatory FFPE tumor tissue sample;
- •Inclusion Criteria Specific to Subjects With Richter's Syndrome –
- •Lenalidomide Combination Therapy Expansion Arm 2B
- •Have tumor biopsy-proven CD20+ DLBCL and a clinical history of
- •Deemed as ineligible for chemoimmunotherapy
- •Eligible for treatment with lenalidomide.
- •Must have measurable disease as determined by FDG- PET CT and a CT
- •scan (or MRI)
- •Must provide a mandatory FFPE tumor tissue sample;
- •Females of childbearing potential must use 2 forms of contraception
- •A woman of childbearing potential must have a negative serum (betahCG) pregnancy test
- •Males must always use a latex or synthetic condom during any sexual
- •contact with females of reproductive potential while taking lenalidomide
- •Inclusion Criteria Specific to Subjects With Richter's Syndrome – R-CHOP
- •Combination Therapy Expansion Arm 2C
- •Have tumor biopsy-proven CD20+ DLBCL and have a clinical history of
- •Eligible to receive R-CHOP per investigator determination.
- •Must have measurable disease as determined by FDG- PET CT and a CT
- •scan (or MRI)
- •Must provide a mandatory FFPE tumor tissue sample;
- •Inclusion Criteria Specific to Subjects with R/R CLL – Venetoclax
- •Combination Therapy Dose Escalation Cohorts and Expansion Arm 3
- •Must have active CLL/SLL disease that needs treatment
- 另有 9 项未显示
排除标准
- •All Subjects
- •Subject received prior treatment with a CD3×CD20 bsAb.
- •Subject received any prior allogeneic HSCT or solid organ
- •transplantation
- •Subject received treatment with an anticancer agent, as follows:
- •- Subject received treatment with an investigational drug, within 4
- •weeks or 5 half lives, whichever is shorter, prior to the first dose of
- •epcoritamab.
- •Subject has autoimmune disease or other diseases that require
- •permanent or high-dose immunosuppressive therapy
- •Uncontrolled autoimmune hemolytic anemia or immune
- •thrombocytopenia (requiring >20 mg of prednisolone daily) or other
- •concurrent uncontrolled medical conditions.
- •Unstable or uncontrolled disease/condition related to or affecting
- •cardiac function, eg, unstable angina, congestive heart failure grade III
- •or IV as classified by the New York Heart Association (see Appendix 3),
- •uncontrolled clinically significant cardiac arrhythmia (CTCAE v5.0 grade
- •2 or higher), or clinically significant ECG abnormalities
- •Myocardial infarction, intracranial bleed, or stroke within the past 6
- •Subject age =75 and 2 or more active grade =2 cardiovascular
- •conditions.
- •Subject has toxicities from previous anticancer therapies that have not
- •resolved to baseline levels or to grade 1 or less except for alopecia and
- •peripheral neuropathy
- •Subject has history or presence of clinically relevant disorder affecting
- •ICE score of less than 8 at study entry
- •Subject has known past or current malignancy other than inclusion
- •diagnosis, except for:
- •a.Cervical carcinoma of Stage 1B or less
- •b.Non-invasive basal cell or squamous cell skin carcinoma
- •c.Non-invasive, superficial bladder cancer
- •d.Prostate cancer with a current PSA level <0.1 ng/mL
- •e.Any curable cancer with a CR of >2 years duration
- •Subject has suspected allergies, hypersensitivity, or intolerance to
- •epcoritamab or another anti-CD20 mAb or its excipients (refer to the IB
- •for more information).
- •Active HBV (DNA PCR-positive). Subjects with evidence of prior HBV
- •but who are PCR-negative are permitted in the trial but should receive
- •prophylactic antiviral therapy.
- •Active hepatitis C (RNA PCR-positive infection). Subjects who received
- •treatment for HCV that was intended to eradicate the virus may
- •participate if hepatitis C RNA levels are undetectable
- •Subject is a woman who is pregnant or breastfeeding, or who is
- •planning to become pregnant while enrolled in this trial or within 12
- •months after the last dose of epcoritamab.
- •Subject is a man who plans to father a child while enrolled in this trial
- •or within 12 months after the last dose of epcoritamab
研究者
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