EUCTR2021-001695-42-FR招募中1 期
A Phase 1/2 study of CAN04, a fully humanised monoclonal antibody against IL1RAP, in combination with different chemotherapy regimens in subjects with advanced solid tumours
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Cantargia AB
- 入组人数
- 165
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
- 性别
- All
入选标准
- •1. Subjects >= 18 years of age
- •2. ECOG 0-1
- •1. Subject has histologically or cytologically confirmed diagnosis of locally advanced cancer or metastatic cancer.
- •2. Subject has a condition where all standard therapeutic options with proven survival benefit have been exhausted, refused by the subject, or are contraindicated. OR Subject has a condition where 1 of the 3 study regimens (mFOLFOX, DTX, or G/C) is considered SoC for the next-line treatment.
- •1. Subject must have at least 1 measurable lesion as defined by RECIST v1.1.
- •2. Subjects with histologically or cytologically confirmed metastatic or locally advanced adenocarcinoma of rectum or colon, squamous or non-squamous unresectable stage IIIB or stage IV NSCLC, or non-resectable, recurrent, or metastatic biliay tract cancer amenable for G/C treatment
- •For a complete list of inclusion criteria, please refer to Protocol, section 4.1.1 Inclusion Criteria
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •General Study Exclusion Criteria:
- •1. Subject has a known or suspected allergy to study drugs (including chemotherapy regimens), any of its components.
- •2. Subject has another histologically confirmed cancer different from those described in inclusion criteria, except for cervical carcinoma in situ,
- •superficial non-invasive bladder tumour, curatively treated stage I non-melanoma skin cancer, or prostate cancer subjects curatively treated with surgery or radiation and not receiving systemic or androgen deprivation therapy.
- •3. Subject has uncontrolled or significant heart failure defined as New York Heart Association Classification III or IV.
- •4. Subjects to receive mFOLFOX or DTX: having peripheral sensory neuropathy Grade =2.
- •5. Subject has QT interval corrected using Fridericia’s formula (QTcF) >480 msec at screening.
- •6. Subjects to receive DTX and CAN04: if they have liver metastases and aspartate aminotransferase (AST) and/or ALT >1.5 × upper limit of normal (ULN) concomitant with alkaline phosphatase >2.5 × ULN.
- •7. Subject has uncontrolled brain metastases. Subjects are allowed to be enrolled if brain metastasis has been previously treated with surgery, and/or stereotactic radiosurgery and are considered controlled (controlled by the dose =10 mg/day of prednisone or equivalent) at the time of the first dose of CAN04. For asymptomatic subjects, brain imaging during screening is not required.
- •8. Subject has an active severe infection requiring parenteral antibiotics at the time of enrolment or subjects currently receiving oral antibiotics as a continuation of a previous course of parenteral antibiotics. Subjects can be enrolled when antibiotic treatment is complete and if there are no signs of residual infection.
- •9. Subject has a history of autoimmune disease requiring systemic immunosuppressive therapy (daily prednisone equivalent doses >10 mg/day).
- •10. Subject is expected to require any other form of systemic or localised anti-neoplastic therapy while on study (including maintenance therapy with another agent, radiation therapy, and/or surgical resection).
- •11. Subject has had an allogeneic tissue/solid organ transplant.
- •For a complete list of exclusion criteria, including Dose Escalation Phase (Phase 1) and Phase 2 please refer to Protocol, section 4.1.2 Study Exclusion Criteria
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