EUCTR2014-003277-42-NO进行中（未招募）1 期
A Phase I/II Study of MCLA-128, a full length IgG1 Bispecific Antibody Targeting HER2 and HER3, in Patients with Solid Tumors (eNRGy)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Merus N.V.
- 入组人数
- 458
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.Age =18 yrs
- •2.=1 measurable lesion, RECIST v1.1 or evaluable disease for a limited number of patients in group H
- •3.ECOG 0, 1 or 2
- •4.life expectancy =12 wks
- •5. Toxicities incurred as a result of previous anti-cancer therapy resolved to =Grade 1 except for alopecia, Grade 2 sensory neurotoxicity, or any other toxicity that in the opinion of the investigator does not affect the assessment of adverse events related to the study drug
- •6.Treatment with anti-cancer or investigational product within set intervals before first dose of IMP:
- •a.>14d or >5 half-lives prior to study entry, whichever is shorter.
- •b.>14d for radiotherapy. Note: A less than 1-week wash-out period is permitted only for palliative radiation to non-CNS disease with Sponsor approval.
- •7.Recovery from prior surgery/other procedure/ complication to = Grade 2 or to baseline condition that in opinion of the investigator does not affect the assessment of adverse events related to the study drug;
- •8.Screening Lab values:
- •a.Absolute neutrophil count =1.5 x 10^9/L without colony stimulating factor support for at least 7 days prior to Screening;
- •b.Platelets =75 x 10^9/L without transfusion support for at least 7 days prior to Screening;
- •c.Hemoglobin =8 g/dL or =5 mmol/L;
- •d.ALT, AST =3 x ULN and total bilirubin =1.5 x ULN (for exceptions please refer to protocol)
- •e.Estimated glomerular filtration rate (GFR) of >30 mL/min based on the Cockroft-Gault formula;
- •9.Able to provide at baseline a mandatory tumor biopsy sample, preferably a block. If safe/feasible, a fresh FFPE biopsy sample is preferred; archival tissue is acceptable (preferably not more than 2 years old
- •Note 1: For patients who received afatinib or other HER-targeting agents, a biopsy collected after the last line of treatment is strongly preferred to assess for mechanisms of acquired resistance
- •Note 2: For patients with a locally confirmed NRG1 gene fusion, when archival tissue is not available and collection of a fresh biopsy is not safe or feasible during the screening period, these patients will be allowed to enroll in the MCLA128-CL01 trial provided they meet all other inclusion/exclusion criteria.
- •10.Negative pregnancy test at Screening and =7 days of D1
- •Note: Women with amenorrhea associated with prior treatment with antineoplastic medications are still considered as being of child-bearing potential.
- •11.Sexually active male and female patients of childbearing potential must agree to use one of the highly effective methods of birth control during entire study and 6 months after final administration of MCLA-128
- •12.Give written informed consent
- •13.Capable of understanding protocol requirements, is willing and able to comply with study procedures and has signed the main informed consent document. For any optional biopsy sampling (tissue and/or blood) and long-term sample storage, additional consent is required
- •14. Patients must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the Investigator, would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy or no satisfactory alternative treatment options are available;
- •15. Histologic or cytologic diagnosis of locally-advanced unresectable or metastatic solid tumor malignancy with a documented NRG1 gene fusion, identified through molecular assays such as PCR, next generation sequencing-based assays [DNA or RNA], as routinely performed ast CLIA or other sim
排除标准
- •1. Pregnant or lactating;
- •2. Presence of an active uncontrolled infection or an unexplained fever greater than 38.5°C during Screening up to the first scheduled day of dosing. At the discretion of the Investigator, patients with tumor fever or a clinically insignificant minor infection may be enrolled (i.e. mild upper respiratory infection);
- •3. Known hypersensitivity to any of the components of MCLA-128 or history of severe hypersensitivity reactions to human or humanized monoclonal antibodies, including therapeutic antibodies;
- •4. Patients with the following infectious diseases are excluded:
- •a. known HIV
- •b. active Hepatitis B infection (HBsAg positive) without receiving antiviral treatment
- •Patients with active hepatitis B (HBsAg positive) must receive antiviral treatment with lamivudine, tenofovir, entecavir, or other antiviral agents, starting at least = 7 days before the initiation of the study treatment.
- •Patients with antecedents of Hepatitis B (anti-HBc positive, HBsAg and HBV-DNA negative) are eligible.
- •c. positive test for Hepatitis C ribonucleic acid (HCV RNA)
- •Patients in whom HCV infection resolved spontaneously (positive HCV antibodies without detectable HCV-RNA) or those that achieved a sustained response after antiviral treatment and show absence of detectable HCV RNA = 6 months (with the use of IFN-free regimens) or = 12 months (with the use of IFN-based regimens) after cessation of antiviral treatment are eligible;
- •NOTE: Patients without known or suspected HIV, Hepatitis B or Hepatitis C infection do not require specific viral testing during the screening period.
- •5. Known symptomatic or unstable brain metastases. Patients with asymptomatic brain metastases are eligible to participate if the metastases have been radiographically and clinically stable for at least one month. If on steroids for this indication, the patient must be on a stable dose for at least one month.
- •6. Patients with leptomeningeal metastases
- •7. Previous or concurrent malignancy (excluding non-basal cell carcinoma of skin or carcinoma in situ of the uterine cervix) unless the tumor was treated with curative or palliative intent and in the opinion of the investigator, with sponsor agreement, the previous or concurrent malignancy condition doesn’t affect the assessment of safety and efficacy of the study drug;
- •8. Presence of LVEF< 50% on the screening echocardiogram; or history or presence of any significant cardiovascular disease, including unstable angina or myocardial infarction within 12 months prior to screening, congestive heart failure (NYHA Class III or IV) or ventricular arrhythmia requiring medication;
- •9. Presence of any other medical or psychological condition deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate or participate in the study, or interfere with the interpretation of the results.
研究者
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