ISRCTN35774409已完成1 期
An open-label, multicenter, dose escalation phase Ib study with expansion cohorts to evaluate the safety, pharmacokinetics, pharmacodynamics and therapeutic activity of RO7009789 (CD40 agonistic monoclonal antibody) in combination with vanucizumab (Anti-Ang2 and Anti-VEGF bi-specific monoclonal antibody, part I) or bevacizumab (Anti-VEGF monoclonal antibody, part II) in patients with metastatic solid tumors
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 94
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
- •Part I (dose escalation):
- •1. Histologically confirmed advanced/metastatic solid tumor (except prostate cancer and squamous non-small cell lung cancer [NSCLC])
- •Part II (expansion):
- •1. Histologically confirmed advanced/metastatic platinum-resistant ovarian carcinoma (aPROC), head and neck squamous cell carcinoma (HNSCC), or non-squamous NSCLC previously treated with anti-PD-L1/PD-1 inhibitor alone or in combination (e.g. atezolizumab, nivolumab, pembrolizumab, durvalumab, avelumab)
- •2. Checkpoint inhibitor (CPI)- experienced patients must have experienced documented disease progression on or after PD-L1/PD-1 inhibitor therapy
- •3. In CPI-experienced patients, the PD-L1/PD-1 inhibitor must have been part of the most recent systemic anticancer therapy administered prior to study enrollment
- •4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- •5. Life expectancy =16 weeks
- •6. Adequate hematologic, renal, hepatic, and cardiovascular function
- •7. Measurable disease per Response Evaluation Criteria in Solid Tumors, v 1.1 (RECIST v1.1)
- •8. Tumors must be acceptable for biopsy. Participants in part II may be enrolled without a biopsy if the collection is not clinically feasible.
- •9. Agreement to use adequate contraceptive measures among men or among women of childbearing potential
排除标准
- •Part I (dose escalation):
- •1. Prostate cancer or squamous NSCLC
- •2. Recent systemic anti-cancer treatment
- •3. Prior treatment with anti-programmed death (PD) 1 or anti-programmed death ligand (PD-L) 1 therapeutic antibody, vanucizumab, or compounds targeting cluster of differentiation (CD) 40 less than 4 weeks or 5xt1/2 (whichever is shorter) prior to enrollment
- •Part II (expansion):
- •1. Treatment targeting vascular endothelial growth factor (VEGF) or receptor within 12 months prior to enrollment
- •2. Systemic immunosuppressive medication within 2 weeks prior to day 1 of cycle 1
- •3. Chronic daily treatment with non-steroidal anti-inflammatory drugs
- •4. Unacceptable/unresolved toxicity from prior anti-cancer therapy
- •5. Patients who have had a surgical procedure or significant traumatic injury within 28 days prior to initiation of study treatment, or a core biopsy or other minor surgical procedure within 7 days prior to initiation of study treatment
- •6. Bisphosphonate therapy for symptomatic hypercalcemia
- •7. Significant vascular disease
- •8. History of hypertensive crisis or hypertensive encephalopathy
- •9. Current or recent use of aspirin (>325 mg/day) or clopidogrel (>75 mg/day)
- •10. History of vein thrombosis/thromboembolism, or use of anticoagulants within 7 days prior to study drug
- •11. Primary tumor in place in participants with colorectal cancer, or evidence of bowel involvement (metastasis, direct tumor invasion) in participants with other non-gastrointestinal cancer
- •12. Significant cardiovascular or cerebrovascular disease within 6 months prior to D1 of C1
- •13. History of fistula, bowel obstruction, perforation, or abscess
- •14. Prior radiotherapy to pelvis or abdomen, recto-sigmoid involvement, or bowel involvement among participants with aPROC
- •15. Severe non-healing wound, active ulcer, or untreated bone fracture
- •16. Pregnant or lactating women
- •17. History of autoimmune disease
- •18. Human immunodeficiency virus (HIV) or hepatitis B or C
- •19. Severe infection or receipt of a live/attenuated vaccine within 4 weeks prior to D1 of C1
- •20. Other significant malignancies within 3 years prior to D1 of C1
- •21. Allergy/hypersensitivity to study drug
- •22. Prior allogeneic bone marrow or solid organ transplant
- •23. Other conditions/findings that may contraindicate the use of study drug
- •24. Major surgery within 4 weeks prior to study drug
- •25. Known clinically significant liver disease
- •26. History of hemoptysis or bleeding diathesis, or known coagulopathies
- •27. Known symptomatic or untreated central nervous system (CNS) malignancy
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