JPRN-jRCT2031200139已完成2 期
A MULTI-CENTER, OPEN-LABEL, PHASE 2 STUDY TO EVALUATE SAFETY AND EFFICACY OF U3- 1402 IN SUBJECTS WITH ADVANCED OR METASTATIC COLORECTAL CANCER (CRC)
Inoguchi Akihiro0 个研究点目标入组 80 人开始时间: 2020年10月8日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
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
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Inclusion Criteria:
- •Participant has provided written informed consent prior to the start of any study specific procedures.
- •Participants >=18 years (follow local regulatory requirements if the legal age of consent for study participation is >18 years old).
- •Pathological/histological confirmation of advanced or metastatic colon or rectal adenocarcinoma.
- •Must be resistant, refractory, or intolerant to at least 2 prior lines of systemic therapy, that must include all of the following agents:
- •Fluoropyrimidine
- •Platinum agents (e.g, oxaliplatin)
- •An anti-epidermal growth factor receptor (EGFR) agent, if clinically indicated
- •An anti-VEGF agent, unless contraindicated (eg, bevacizumab)
- •An immune checkpoint inhibitor (eg, microsatellite instability-high [MSI-H] status)
- •A BRAF inhibitor, if clinically indicated (eg, BRAF V600E positive)
- •Has at least 1 measurable lesion confirmed by blinded independent central review (BICR) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1.
- •Willing to provide a required pre-treatment tumor biopsy and an additional archival tissue sample for the assessment of HER3 expression levels by immunohistochemistry and exploratory biomarkers, defined as:
- •Pre-treatment tumor biopsy. Participants may be exempted from the requirement to provide a pre-treatment tumor biopsy if archival tumor tissue was collected within 3 months of screening during or after treatment with the last prior cancer treatment and is of sufficient quantity (2 cores or 20 slides with adequate tumor tissue content).
- •An additional archival tissue sample collected greater than 3 months prior to screening must be available and of sufficient quantity, as defined above, at the time of screening. If an archival tissue sample (collected greater than 3 months prior to screening) is not available, a subject may be included provided the pre-treatment tumor biopsy is obtained and after discussion and agreement from Sponsor (Medical Monitor or designee).
- •Consent to provide on-treatment tumor biopsy. When at least 10 treatment tumor biopsies have been collected, the Sponsor will provide written notification of a change to the requirement.
- •Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
- •Life expectancy >=3 months.
- •Has adequate bone marrow reserve and organ function at baseline based on local laboratory data defined as follows within 14 days prior to Cycle 1 Day 1:
- •Platelet count: >=100,000/mm^3 or >=100 x 10^9/L (platelet transfusions are not allowed up to 14 days prior to Cycle 1 Day 1 to meet eligibility)
- •Hemoglobin: >=9.0 g/dL (transfusion and/or growth factor support is allowed)
- •Absolute neutrophil count: >=1500/mm^3 or >=1.5 x 10^9/L
- •Serum creatinine (SCr) OR creatinine clearance (CrCl): SCr <= 1.5 x upper limit of normal (ULN), OR CrCl >= 30 mL/min as calculated using the Cockcroft- Gault equation or measured CrCl; confirmation of CrCl is only required when creatinine is >1.5 x ULN
- •Alanine aminotransferase /aspartate aminotransferase: <=3 x ULN (if liver metastases are present, <=5 x ULN)
- •Total bilirubin: <=1.5 x ULN if no liver metastases (<3 x ULN in the presence of documented Gilbert's syndrome [unconjugated 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) / partial thromboplastin time (PTT): <=1.5 x ULN except for subjects on coumarin- derivative anticoagulants or ot
排除标准
- •- Any history of interstitial lung disease (including pulmonary fibrosis or radiation pneumonitis), has current interstitial lung disease (ILD), or is suspected to have such disease by imaging during screening.
- •- Clinically severe pulmonary compromise (based on Investigator's assessment) resulting from intercurrent pulmonary illnesses including, but not limited to:
- •1. any underlying pulmonary disorder (e.g., pulmonary emboli, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion)
- •2. any autoimmune, connective tissue or inflammatory disorder with pulmonary involvement (eg, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis) OR prior complete pneumonectomy.
- •- Is receiving chronic systemic corticosteroids dosed at >10 mg prednisone or equivalent anti-inflammatory activity or any form of immunosuppressive therapy prior to Cycle 1 Day 1. Participants who require use of bronchodilators, inhaled or topical steroids, or local steroid injections may be included in the study.
- •- Evidence of leptomeningeal disease.
- •- Evidence of clinically active spinal cord compression or brain metastases
- •- Inadequate washout period prior to Cycle 1 Day 1 of U3-1402:
- •1. Whole brain radiation therapy <14 days or stereotactic brain radiation therapy <7 days;
- •2. Any cytotoxic chemotherapy, investigational agent or other anticancer drug(s) from a previous cancer treatment regimen or clinical study <14 days or 5 half-lives, whichever is longer;
- •3. Monoclonal antibodies other than immune checkpoint inhibitors, such as bevacizumab (anti-VEGF) and cetuximab (anti-EGFRs) <28 days;
- •4. Immune checkpoint inhibitor therapy <21 days;
- •5. Major surgery (excluding placement of vascular access) <4 weeks;
- •6. Radiotherapy treatment to >30% of the bone marrow or with a wide field of radiation <28 days or palliative radiation therapy <14 days;
- •7. Chloroquine/hydroxychloroquine <=14 days
- •- Prior treatment with an anti-HER3 antibody and/or antibody drug conjugate (ADC) that consists of an exatecan derivative that is any topoisomerase I inhibitor (e.g, trastuzumab deruxtecan).
- •- Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 Grade <=1 or baseline.
- •- Had primary malignancies other than CRC within 3 years prior to Cycle 1 Day 1, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated.
- •- Uncontrolled or significant cardiovascular disease prior to Cycle 1 Day 1.
- •- Known Hepatitis B and/or Hepatitis C infection, such as those with serologic evidence of viral infection within 28 days of Cycle 1 Day 1.
- •1.Participants with past or resolved hepatitis B virus (HBV) infection are eligible if:
- •Hepatitis B surface antigen (HBsAg) negative and hepatitis B core antibody (anti-HBc) positive; OR
- •HBsAg positive and HBV deoxyribonucleic acid (DNA) viral load is documented to be <=2000 IU/mL in the absence of anti-viral therapy and during the previous 12 weeks prior to the viral load evaluation with normal transaminases values (in the absence of liver metastasis); OR
- •HBsAg positive and HBV DNA viral load is documented to be <=2000 IU/mL in the absence of anti-viral therapy and during the previous 12 weeks prior to the viral load evaluation for participants with liver metastasis and abnormal transaminases with a result
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