NL-OMON55468已完成不适用
A Phase 1/1b First-in-human Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of SAR439459 Administered Intravenously as Monotherapy and in Combination with cemiplimab in Adult Patients with Advanced Solid Tumors - TCD14678
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Dose escalation (Part 1A and Part 1B):, -Patients with histologically
- •confirmed, advanced unresectable or metastatic solid tumor whom in the opinion
- •of the Investigator does not have a suitable alternative therapy.,
- •Dose expansion (Part 2A):, -Patients with histologically confirmed, advanced
- •unresectable melanoma whom in the opinion of the Investigator does not have a
- •suitable alternative therapy
- •-Patients must have failed any prior therapy based on anti-PD-1 or anti-PD-L1
- •as defined by disease progression within 26 weeks of initiating anti-PD-1 or
- •anti-PDL-1-based therapy without any evidence of a response.
- •-Patients must have a site of disease amenable to biopsy and be a candidate for
- •tumor biopsy.
- •-Patients must be able and willing to provide mandatory tumor biopsies prior to
- •and during study treatment.,
- •Dose expansion (Part 2B):, -Patients with avanced unresectable or metastatic
- •melanoma who failed after one prior therapy based on anti-PD-1 or anti-PD-L1 or
- •colorectal adenocarcinoma with mesenchymal molecular subtype or urothelial
- •cancer and have failed platinum-containing chemotherapy or non-small cell lung
- •cancer (NSCLC) after failure of anti-PD-1 or anti PD-L1, or hepatocellular
- •carcinoma (HCC) after failure of anti-PD-1 or anti PD-L1, with or without
- •bevacizumab.
- •For all indications patients must not have a suitable alternative approved
- •standard therapy available in the opinion of the investigator or must be
- •refused by the patient., Dose expansion parts 2A and 2B:, -At least 1
- •measurable lesion by RECIST v1.1.
排除标准
- •-Age < 18 years.
- •-Eastern Cooperative Oncology Group (ECOG) performance status >1.
- •-Concurrent treatment with any other anticancer therapy (including radiotherapy
- •or investigational agents) or participation in another clinical study.
- •-Washout period of less than 3 weeks to prior anticancer therapy.
- •-Significant and uncontrolled concomitant illness, including any psychiatric
- •-Active infections, including unexplained fever (temperature >38.1ºC), or
- •antibiotic therapy within 1 week prior to enrollment.
- •-Any prior organ transplant including allogeneic bone marrow transplant.
- •-History within the last 5 years of an invasive malignancy other than the one
- •treated in this study.
- •-History of known HIV, unresolved viral hepatitis.
- •-Any major surgery within the last 28 days.
- •-Patients with primary central nervous system (CNS) tumors and/or CNS
- •metastases of non-CNS primary tumors that are untreated.
- •-History of severe, acute or chronic heart diseases.
- •-History of severe, acute or chronic renal diseases or inadequate renal
- •-History of significant valvular heart disease (including valve replacement),
- •vascular malformation and anurysm
- •-Any of the following within 6 months prior to study enrollment: pulmonary
- •embolism, deep vein thrombosis, active uncontrolled bleeding, infectious or
- •inflammatory bowel disease, diverticulitis, intestinal obstruction or
- •perforation and gastrointestinal hemorrhage.
- •-Inadequate hematological, renal or liver function.
- •-Non-resolution of any prior treatment related toxicity to Grade <2.
- •-Prior treatment with any anti-TGF-β inhibitors.
- •-Known allergies to any component of SAR439459 and/or REGN2810.
- •-Patients with uveal melanoma and patients with prior or ongoing uveitis.
- •-Patients who received prior immunotherapy who developed toxicity leading to a
- •permanent discontinuation of immunotherapy.
- •-Ongoing or recent (within 2 years) evidence of significant autoimmune disease
- •that required treatment with systemic immunosuppressive treatments.
- •-Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent)
- •within 4 weeks prior to the first dose of SAR439459 and/or REGN2810 (occasional
- •use of inhaled, intraocular, nasal or topical steroids for symptomatic relief
- •-History of pneumonitis or bowel perforation.
- •-Patients with underlying cancer predisposition syndromes.
- •-Therapeutic doses of anticoagulants or antiplatelet agents within 7 days prior
- •the first dose of SAR439459
- •-Receipt of a live vaccine within 30 days of planned start of study medication.
- •-Prothrombin time (PT) or international normalized ratio (INR) > 1.5 × ULN
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