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临床试验/NL-OMON56321
NL-OMON56321招募中2 期

Phase 1/2 dose escalation and cohort expansion study evaluating MCLA-158 (Petosemtamab) as single agent or in combination in advanced solid tumors - Clinical study evaluating MCLA-158 in metastatic cancer

Merus N.V.0 个研究点目标入组 34 人开始时间: 待定最近更新:
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适应症

试验速览

阶段
2 期
状态
招募中
发起方
Merus N.V.
入组人数
34
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 ICF before initiation of any study procedures
  • •2. Age >=18 years at signing of ICF
  • •3. Histologically or cytologically confirmed solid tumors with evidence of
  • •metastatic or locally advanced disease not amenable to standard therapy with
  • •curative intent:
  • •Expansion cohorts: patients with locally advanced unresectable or metastatic
  • •disease for the following indications:
  • •SINGLE AGENT
  • •o 2L/3L HNSCC PATIENTS: patients who have progressed on or after, or are
  • •intolerant to, anti-PD-(L)1 and platinum therapy as monotherapy or in
  • •combination with other agents and no previous exposure to EGFR inhibitors.
  • •Patients treated with platinum-containing therapy only in the adjuvant setting,
  • •or in the context of multimodal therapy for locally advanced disease, should
  • •have disease progression within 6 months of the last dose of platinum
  • •containing therapy. Patients should not have received more than 2 prior lines
  • •of treatment in recurrent or metastatic disease.
  • •* Human papillomavirus (HPV) status determined by p16 IHC or molecular HPV test
  • •for all oropharyngeal tumors should be reported when available.
  • •* The eligible HNSCC primary tumor locations are oropharynx, oral cavity,
  • •hypopharynx, and larynx.
  • •o Cancers of the anogenital tract with squamous cell histology (ie, cervical,
  • •vaginal, vulvar, penile, anal)
  • •o NSCLC non-SCC and NSCLC SCC
  • •o GEA with histologically confirmed EGFR amplification (fluorescence in situ
  • •hybridization [FISH] score EGFR/ chromosome 7 (CEP7) ratio >=2.0, or tumor NGS
  • •EGFR copy >=8, or ctDNA >=4, or EGFR IHC H-score >=200)
  • •o mCRC in 3L+: Patients should be free of mutations in RAS family genes (i.e.
  • •KRAS, NRAS, Harvey Rat Sarcoma virus [HRAS], or RAF family genes (i.e. BRAF,
  • •A-Rapidly Accelerated Fibrosarcoma [ARAF}, Rapidly Accelerated Fibrosarcoma-1
  • •[RAF1]), determined by central ctDNA NGS prescreening]). Note: If the patient
  • •was treated with an EGFR inhibitor in 1L or 2L, then the patient should have
  • •shown CR/PR. In addition, the patient at study entry should have at least 6
  • •months of interval since the last administration of EGFR inhibitor.
  • •Other indications may be considered, such as malignant salivary gland tumors.
  • •Note 1: Patients with NSCLC must receive all recommended standard therapies
  • •driven by the histological subtype and tumor molecular profile.
  • •Note 2: Patients with other indications must have been previously treated
  • •with 1 or 2 lines of the standard approved therapy (when applicable) in the
  • •locally advanced/unresectable or metastatic setting.
  • •COMBINATION
  • •o 1L HNSCC: patients eligible to receive pembrolizumab as 1L monotherapy with
  • •tumors expressing PD-L1, CPS >=1, as determined by an FDA-approved test in the
  • •US, or by an approved equivalent test in other countries; patients should not
  • •have previous systemic therapy administered in the recurrent or metastatic
  • •setting, although previous systemic therapy as part of multimodal treatment for
  • •locally advance disease is allowed if ended >=6 months prior to signing the ICF.
  • •The eligible HNSCC primary tumor locations are oropharynx, oral cavity,
  • •hypopharynx, and larynx. Previous treatments with anti-PD-(L)1 or anti-EGFR
  • •therapies are not allowed.
  • •o 2L mCRC: Patients should have been previously diagnosed with histologically
  • 另有 1 项未显示

排除标准

  • •1. Central nervous system metastases that are untreated or symptomatic, or
  • •require radiation, surgery, or continued steroid therapy to control symptoms
  • •within 14 days of study entry
  • •2. Known leptomeningeal involvement
  • •3. Participation in another clinical trial or treatment with any
  • •investigational drug within 4 weeks prior to study entry
  • •4. Any systemic anticancer therapy within 4 weeks or 5 half-lives, whichever is
  • •shorter, of the first dose of study treatment. For cytotoxic agents that have
  • •major delayed toxicity (eg, mitomycin C, nitrosoureas), or anticancer
  • •immunotherapies, a washout period of 6 weeks is required.
  • •5. Requirement for immunosuppressive medication (eg, methotrexate,
  • •cyclophosphamide)
  • •6. Major surgery or radiotherapy within 3 weeks of the first dose of study
  • •treatment. Patients who received prior radiotherapy to >=25% of bone marrow are
  • •not eligible, irrespective of when it was received.
  • •7. Persistent Grade >1 clinically significant toxicities related to prior
  • •antineoplastic therapies (except for alopecia); stable sensory neuropathy Grade
  • •<=2 National Cancer Institute-Common Terminology Criteria for Adverse Events
  • •(NCI-CTCAE) v4.03 is allowed.
  • •8. History of hypersensitivity reaction to any of the excipients of
  • •petosemtamab, human proteins, or any non-IMP treatment required for this study
  • •9. Uncontrolled hypertension (systolic BP >150 mmHg and/or diastolic BP >100
  • •mmHg) with appropriate treatment; unstable angina; history of congestive heart
  • •failure of Class II-IV New York Heart Association (NYHA) criteria, or serious
  • •cardiac arrhythmia requiring treatment (except atrial fibrillation, paroxysmal
  • •supraventricular tachycardia); or history of myocardial infarction within 6
  • •months of study entry
  • •10. History of prior malignancies with the exception of excised cervical
  • •intraepithelial neoplasia or nonmelanoma skin cancer, or curatively treated
  • •cancer deemed at low risk for recurrence with no evidence of disease for >=3
  • •11. Current dyspnea at rest of any origin, or other diseases requiring
  • •continuous oxygen therapy, including patients with a history of ILD (eg,
  • •pneumonitis or pulmonary fibrosis), or evidence of ILD on baseline chest
  • •computerized tomography (CT) scan
  • •12. Current serious illness or medical conditions including, but not limited
  • •to, uncontrolled active infection, clinically significant pulmonary, metabolic,
  • •or psychiatric disorders
  • •13. Patients with known infectious diseases:
  • •Active hepatitis B infection (hepatitis B surface antigen [HbsAg] positive)
  • •without receiving antiviral treatment. Note:
  • •o Patients who are HbsAg positive must receive antiviral treatment with
  • •lamivudine, tenofovir, entecavir, or other antiviral agents, starting at least
  • •>=7 days before the initiation of study treatment.
  • •o Patients with antecedents of hepatitis B (eg, anti-hepatitis B core
  • •(anti-HBc) positive, HbsAg, and hepatitis B virus [HBV]-DNA negative) are
  • •Positive test for hepatitis C virus (HCV) RNA. Note: Patients in whom HCV
  • •infection resolved spontaneously (ie, positive HCV antibodies without
  • •detectable HCV RNA), or who achieved a sustained response after antiviral
  • •treatment and show absence of detectable HCV RNA >=6 months (with the use of
  • •interferon [IFN]-free regimens) or >=12 months (with the use of IFN-based

研究者

发起方
Merus N.V.

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