KCT0009451尚未招募Unknown
An open label, Phase 2 basket study of patritumab deruxtecan in patients with solid tumor harboring an NRG1 fusion
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 30
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(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •Patients who have signed and dated the tumor tissue informed consent and the main informed consent form (ICF) prior to initiation of any study-specific eligibility verification procedures.
- •Male and female patients 18 years of age or older (if the legal age for self-consent to participate in a clinical trial is higher than 18 years of age, follow local legal and regulatory requirements)
- •-Patients with histologically or cytologically proven locally advanced/metastatic solid tumors that are not curable with curative surgery or radiation therapy.
- •-Patients with documented presence of NRG1 fusions detected by TruSightOncology-500 or Guardant-360 or FoundationOne®CDx (F1CDx), including but not limited to, in tumor tissue or blood specimens.
- •-At least 1 confirmed measurable lesion as assessed by the investigator according to RECIST v1.1
- •-Eastern Cooperative Oncology Group (ECOG) performance status 0-1 at screening
- •- Adequate bone marrow reserve and organ function based on local laboratory test data within 14 days prior to Day 1 of Cycle 1:
- •-Platelet count: = 100,000/mm3 or = 100×109/L (platelet transfusions are not allowed within 14 days prior to Day 1 of cycle 1 to meet eligibility criteria)
- •-Hemoglobin: = 9.0 g/dL (transfusion and/or growth factor supplementation is allowed)
- •-Absolute neutrophil count (ANC): =1500/mm3 or = 1.5×109/L
- •-CrCl serum creatinine (SCr) or creatinine clearance (CrCL): SCr =1.5 × upper limit of normal (ULN) or CrCl = 30 mL/min, calculated by the CockcroftGault formula or measured directly
- •-Asparaginic acid aminotransferase (AST)/alanine aminotransferase (ALT): = 3×ULN (= 5×ULN for patients with liver metastases)
- •-Total bilirubin: = 1.5×ULN, in the absence of liver metastases. (= 3×ULN for patients with proven Gilbert syndrome [hyperbilirubinemia] or liver metastases)
- •-Serum albumin: = 2.5 g/dL
- •-Prothrombin time (PT) or PT-international normalized ratio (INR) and activated partial thromboplastin time (aPTT)/PTT: = 1.5 × ULN, except for patients on coumarin derivative anticoagulants or other similar anticoagulants whose PT-INR values are within the therapeutic range as deemed appropriate by the investigator.
排除标准
- •-Patients with a history of interstitial lung disease (ILD) (including pulmonary fibrosis or radiation pneumonitis) or currently suffering from ILD or with suspected presence of such disease on imaging studies performed at screening.
- •-Clinically significant respiratory failure (as assessed by the Investigator) due to concomitant lung disease, including but not limited to:
- •o Any underlying pulmonary disorder (e.g. pulmonary embolism within 3 months prior to study enrollment, severe asthma, severe chronic obstructive pulmonary disease [COPD], restrictive lung disease, pulmonary effusion)
- •o Any autoimmune/connective tissue/inflammatory disorder with pulmonary involvement (e.g., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis); or history of total pneumonectomy
- •Chronic use of systemically active corticosteroids (prednisone at doses greater than 10 mg or equivalent), anti-inflammatory drugs, or other immunosuppressive agents in any form prior to enrollment. Patients who require the use of bronchodilators, inhaled/external steroids, or topical steroid injections may participate in the study.
- •-Evidence of leptomeningeal disease
- •-Evidence of clinically active spinal cord compression or brain metastasis
- •-Prior to Day 1 of cycle 1, inadequate extracorporeal emptying, defined as
- •o Less than 14 days of whole brain radiotherapy or less than 7 days of brain stereotactic radiotherapy
- •o Less than 14 days or 5 times the half-life (whichever is longer) of any cytotoxic chemotherapeutic agent, investigational drug, or other anticancer agent (other than an EGFR TKI) included in a prior chemotherapy regimen or clinical trial.
- •o Monoclonal antibodies other than immune checkpoint inhibitors, including bevacizumab (anti-VEGF) or cetuximab (anti-EGFR), for less than 28 days
- •o Immune checkpoint inhibitors for less than 21 days
- •o Major surgery (excluding vascular access device placement) < 28 days
- •o Less than 28 days of radiation therapy to greater than 30% of the bone marrow or a large area, or less than 14 days of hyperfractionated radiation therapy
- •o Chloroquine or hydroxychloroquine less than 14 days
- •-Previous administration of human epithelial growth factor receptor type 3 (HER3) antibodies or topoisomerase I inhibitors alone.
- •-Previous administration of an antibody-drug conjugate (ADC) containing a topoisomerase I inhibitor.
- •-Unresolved toxicity from prior anticancer therapy. Unresolved toxicity is defined as Grade 1 or less according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 or unresolved toxicity at baseline, except alopecia. Patients with chronic grade 2 toxicity may be eligible for study participation at the discretion of the investigator.
- •-History of other active malignancy within 3 years prior to enrollment, with the following exceptions
- •o Adequately treated non-melanoma skin cancer.
- •o Superficial bladder cancer (Ta, Tis, T1)
- •o Well-differentiated thyroid cancer
- •o Adequately treated cervical intraepithelial carcinoma
- •o Low-risk, non-metastatic prostate cancer (Gleason score less than 7 and has been treated locally or is currently on active surveillance)
- •o Other curatively treated carcinoma in situ
- •-Uncontrolled or significant cardiovascular disease present prior to Day 1 of Cycle 1
- •-Currently active hepatitis B and/or C infection, including serologic evidence of viral infection within 28 days prior to Day 1 of Cycle 1
- •-Patients with human i
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