Phase 1/2 dose escalation and expansion study evaluating MCLA-129, a human anti-EGFR and anti-c-MET bispecific antibody, in patients with advanced NSCLC and other solid tumors - Phase 1/2 study of MCLA-129 in patients with NSCLC and other solid tumors

Merus N.V.0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

阶段: 不适用
状态: 尚未招募
发起方: Merus N.V.
入组人数: 30

研究概览入排标准研究者记录与标识符相似试验

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. Signed informed consent before initiation of any study procedures.
•2. Age >= 18 years at signature of informed consent.
•3. Histologically or cytologically confirmed solid tumors with evidence of
•metastatic or locally advanced unresected disease that is incurable.
•4. Availability of archival or a fresh tumor tissue sample.
•5. Measurable disease as defined by RECIST version 1.1 by radiologic methods.
•6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
•7. Life expectancy >= 12 weeks, as per Investigator.
•8. Adequate organ function.

排除标准

•1. Central nervous system metastases that are untreated or symptomatic, or
•require radiation, surgery, or continued steroid therapy (> 10 mg prednisone or
•equivalent) to control symptoms within 14 days of study entry.
•2. Known leptomeningeal involvement.
•3. Participation in another clinical study or treatment with any
•investigational drug within 4 weeks prior to study entry.
•4. Prior treatment with a bispecific EGFR-c-MET antibody.
•5. Systemic anticancer therapy or immunotherapy within 4 weeks or 5 half-lives,
•whichever is shorter, of the first dose of study drug. For cytotoxic agents
•that have major delayed toxicity (e.g., mitomycin C, nitrosoureas), a washout
•period of 6 weeks is required. Note: For agents with long half-lives,
•enrollment before the fifth half-life requires Sponsor approval.
•6. Major surgery or radiotherapy within 3 weeks of the first dose of study
•drug. Patients who received prior radiotherapy to >=25% of bone marrow at any
•time are not eligible.
•7. Persistent grade >1 clinically significant toxicities related to prior
•antineoplastic therapies (except for alopecia); stable sensory neuropathy <=
•grade 2 NCI-CTCAE v5.0 and hypothyroidism <= grade 2 which is stable on hormone
•replacement are allowed.
•8. History of hypersensitivity reaction or any toxicity attributed to human
•proteins or any of the excipients that warranted permanent cessation of these
•9. History of clinically significant cardiovascular disease.
•10. History of interstitial lung disease including drug-induced interstitial
•lung disease, radiation pneumonitis that requires treatment with prolonged
•steroids or other immune suppressive agents within 1 year.
•11. Previous or concurrent malignancy, excluding non-basal cell carcinomas 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 does not
•affect the assessment of safety and efficacy of the study drug.
•12. Current dyspnea at rest of any origin, or other diseases requiring
•continuous oxygen therapy.
•13. Current serious illness or medical conditions including, but not limited to
•uncontrolled active infection, clinically significant pulmonary, metabolic or
•psychiatric disorders.
•14. Active Hepatitis B infection (HBsAg positive) without receiving antiviral
•treatment. Note: 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.
•15. Positive test for Hepatitis C ribonucleic acid (HCV RNA); Note: Patients in
•whom HCV infection resolved spontaneously (positive HCV antibodies without
•detectable HCV-RNA) or those who achieved a sustained virological 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.
•16. Known history of HIV (HIV 1/2 antibodies). HIV testing is not required
•unless mandated by local health authority or

研究者

发起方

Merus N.V.

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