NL-OMON56017招募中不适用
A first-in-human dose-escalation and expansion study with the antibody-drug conjugate BYON3521 to evaluate the safety, pharmacokinetics and efficacy in patients with c-MET expressing locally advanced or metastatic solid tumours. - Phase1 study in patients with advanced or metastatic solid tumours
Fortrea Belgium SR0 个研究点目标入组 36 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
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
- •D4a Inclusion criteria
- •1. Male or female, age >=18 years at the time of signing first informed consent;
- •2. Patient with histologically-confirmed, locally advanced or metastatic cancer
- •who has progressed on standard therapy or for whom no standard therapy exists:
- •* Part 1 (dose-escalation): solid tumours of any origin;
- •* Part 2 (expansion):
- •Cohort A: Non-squmous non small cell lung cancer (non-squamous NSCLC) (see
- •exclusion 1.f);;
- •Cohort B: Specific gynaecological cancers: ovarian cancer, endometrial cancer,
- •cervical cancer;
- •Cohort C: HNSCCPancreatic
- •adenocarcinoma (PA););
- •Cohort D: Uveal melanoma
- •3. Part 1: Tumour c-MET positive membrane staining by immunohistochemistry
- •(IHC)a and/or MET amplification by dual In Situ Hybridization (dISH)a and/or
- •known MET-mutation (excluding exon14m)b on most recent available/obtained
- •tumour material from a site not previously irradiated;
- •a as determined by the central laboratory, b in agreement with sponsor
- •art 2: Tumour c-MET membrane expression by immunohistochemistry (IHCor tumour
- •c-MET positive membrane staining by immunohistochemistry (IHC) and MET-mutation
- •(excluding exon14m) score >= 2+) as determined by the central laboratory on
- •most recent available/obtained tumour material from a site not previously
- •irradiated;
- •4. Presence of a tumour lesion accessible for biopsy and patient should be
- •willing to undergo a fresh tumour biopsy, unless adequate biopsy material is
- •available obtained not more than 6 months prior to signing main informed
- •5. Eastern Cooperative Oncology Group (ECOG) performance status <= 1;
- •6. Adequate organ function, evidenced by the following laboratory results:
- •- Absolute neutrophil count >= 1.5 x 109/L;
- •- Platelet count >= 100 x 109/L;
- •- Hemoglobin >= 9.0 g/dL or 5.6 mmol/L;
- •- Total bilirubin <= 1.5 x the upper limit of normal (ULN);
- •- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 3.0 x
- •ULN (or <= 5.0 x ULN in the presence of liver metastases);
- •- Serum creatinine <= 1.5 x ULN;
- •- Estimated Glomerular Filtration Rate (eGFR)* >= 60 ml/min/1.73 m2;
- •*preferably calculated with CKD-EPI formula
- •7. Highly effective contraception must be used during the trial and up to at
- •least 8 months after last IMP treatment for women of childbearing potential and
- •up to at least 6 months after last IMP treatment for male patients with a
- •female partner of childbearing potential. This is not required in case the
- •patient or sole partner is surgically sterilized or in case the patient truly
- •abstains from sexual activity;
- •Additional inclusion criteria for Part 2 only
- •8. At least one measurable cancer lesion as defined by the Response Evaluation
- •Criteria for Solid Tumours (RECIST version 1.1);
- •D4a Main inclusion crititeria
- •1Man of vrouw, leeftijd >= 18 jaar op het moment van ondertekening van de eerste
- •geïnformeerde toestemming;
- •2Patiënt met histologisch bevestigde, lokaal gevorderde of gemetastaseerde
- 另有 6 项未显示
排除标准
- •D5. Exclusion criteria
- •1. Having been treated with:
- •a. DUBA-containing antibody-drug conjugates (ADCs) at any time;
- •b. c-MET targeting cytotoxic agents at any time, including ADC with cytotoxic
- •c. Other anticancer therapy including chemotherapy, immunotherapy, c-MET
- •targeting agent or investigational agent within 4 weeks prior to start IMP
- •treatment or within 5 times the elimination half-life of the therapy, whatever
- •is shorter;
- •d. Radiotherapy within 4 weeks prior to start IMP treatment, or within 1 week
- •for palliative care (as long as the lungs were not exposed);
- •e. Hormone therapy (except for gonadotropin-releasing hormone (GnRH) agonists
- •for prostate cancer or premenopausal breast cancer) within 1 week prior to
- •start IMP treatment;
- •f. Cohort A (non-squamous NSCLC) only: EGFR inhibitors or eligible for EGFR
- •inhibitors at any time;
- •The patient must have sufficiently recovered from any treatment-related
- •toxicities to CTCAE Grade <=1 or baseline, except for toxicities not considered
- •a safety risk for the patient at the investigator*s discretion; (e.g. alopecia
- •or skin hyperpigmentation);
- •2. History of hypersensitivity or allergic reaction to any of the excipients of
- •the IMP treatment which led to permanent discontinuation of the treatment;
- •3. Known presence of a tumour harboring MET exon14 mutation; (Part 1 only);
- •4. History or presence of keratitis;
- •5. History or presence of glomerulonephritis, acute tubular necrosis and/or
- •interstitial nephritis, or clinically significant findings as determined by
- •urinalysis at screening (see Section 9.12, Figure 1);
- •6. History or presence of idiopathic pulmonary fibrosis, organizing pneumonia
- •(e.g. bronchiolitis obliterans), drug-induced or idiopathic pneumonitis, or
- •evidence of active pneumonitis on screening chest CT scan;
- •7. History (within 6 months prior to start IMP) or presence of clinically
- •significant cardiovascular disease such as unstable angina, congestive heart
- •failure, myocardial infarction, uncontrolled hypertension, or cardiac
- •arrhythmia requiring medication;
- •8. Severe, uncontrolled systemic disease (e.g. clinically significant renal,
- •cardiovascular, pulmonary, metabolic disease, skin disease, or autoimmune
- •disease including
- •Sjogren*s syndrom)) at screening;
- •9. Symptomatic brain metastases, brain metastases requiring steroids to manage
- •symptoms, or treatment for brain metastases within 8 weeks prior to start IMP
- •10. Known active Hepatitis B, C or E infection at screening; (prior infections
- •11. Major surgery within 4 weeks prior to start IMP treatment;
- •12. Pregnancy or lactation;
- •13. Other condition that in the investigator*s opinion is likely to jeopardize
- •patient safety or interfere with the patient*s ability to comply with study
- •requirements.
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