CTIS2023-504254-35-00招募中1 期
A multicenter, open-label, non-randomized Phase 1/2 study to assess safety, tolerability, and imaging characteristics of [68Ga]Ga-DPI-4452 and to assess safety, tolerability, and efficacy of [177Lu]Lu-DPI-4452 in patients with unresectable locally advanced or metastatic solid tumors - Debio 0228-101
Debiopharm International S.A.0 个研究点目标入组 155 人开始时间: 2024年1月22日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 155
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 至 65+（—）
- 性别
- All
入选标准
- •1_Part A: Histologically or cytologically confirmed, unresectable locally advanced or metastatic solid tumors of: -ccRCC; - PDAC; - CRC., 10_Parts B, C: Patient ECOG performance status 0-1, 11_Parts B, C: Life expectancy >6 months, 12_Parts B, C: Adequate bone marrow reserve and organ function as demonstrated by complete blood count, and biochemistry in blood and urine at Screening, 13_Parts B, C: Adequate blood counts: - Hemoglobin =9 g/dL - ANC =1.5 × 109/L - Platelets =100 × 109/L, 14_Parts B, C: Adequate hepatic function: - AST, ALT, ALP =3.0×ULN (=5.0×ULN if patient has liver metastases) - Bilirubin =1.5 × ULN (a. up to 2.0 × ULN is allowed if the direct bilirubin level is normal, and the elevation is limited to indirect bilirubin b. Up to 5.0 x ULN in case of Gilbert’s Syndrome), 15_Parts B, C: Adequate renal function: - For PDAC and CRC patients: eGFR >50 mL/min/1.73 m2 (CKD-EPI) - For ccRCC patients: eGFR >40 mL/min/1.73 m2 (CKD-EPI), 16_Parts B, C: Adequate coagulation: - International normalization ratio or prothrombin time =1.5xULN and no history of major thrombotic or clinically relevant major bleeding event in the past 6 months putting the subject at high risk of bleeding during the study as assessed by the Investigator, 2_Part A: Measurable disease as per RECIST v1.1, 3_Part A: Patient ECOG performance status 0-2, 4_Part A: Adequate bone marrow reserve and organ function as demonstrated by complete blood count, and biochemistry in blood and urine at Screening, 5_Part A: Adequate blood counts: - Hemoglobin =8 g/dL - Absolute neutrophil count (ANC) =1.0 × 109/L - Platelets =50 × 109/L, 6_Part A: Adequate hepatic function: - Aspartate or alanine aminotransferase or alkaline phosphatase (AST, ALT, ALP) = 3.0 × upper limit of normal (ULN) (= 5.0 ×ULN if patient has liver metastases) - Bilirubin = 1.5 × ULN (a. up to 2.0 × ULN is allowed if the direct bilirubin level is normal, and the elevation is limited to indirect bilirubin b. Up to 5.0 x ULN in case of Gilbert’s Syndrome), 7_Part A: Adequate renal function: - For PDAC and CRC patients: estimated glomerular filtration rate (eGFR) >50 mL/min/1.73 m² (as determined by the Chronic Kidney Disease - Epidemiology Collaboration - creatinine [CKD-EPIcr] formula) - For ccRCC patients: eGFR > 40 mL/min/1.73 m²(CKD-EPIcr), 8_Parts B, C: Histologically or cytologically confirmed progressive, unresectable locally advanced or metastatic solid tumors of: - ccRCC; - PDAC; - CRC., 9_Parts B, C: Measurable disease per RECIST v1.1
排除标准
- •1_Part A: Known hypersensitivity to the active substance, to any of the excipients of the DPI 4452, or to radiographic contrast agents, 7_Parts B, C: Known hypersensitivity to the active substance, to any of the excipients of the DPI 4452, or to radiographic contrast agents, 8_Parts B, C: Bladder outflow obstruction or unmanageable urinary incontinence, 9_Parts B, C: Administration of a radiopharmaceutical with therapeutic intent within a period of 6 months prior to injection of [68Ga]Ga-DPI-4452, 13_Parts B and C: History of active stomach or duodenum ulcer in the last 2 years, history of gastroesophageal reflux disease (GERD) Grade =3 according to NCI-CTCAE and/or known active gastro-intestinal infection, any unresolved prior radiation-induced gastrointestinal injury. History of gastro-intestinal toxicities from prior systemic cancer therapy not responding to medical treatment., 10_Parts B, C: Any previous CA IX-targeting treatment for more than 1 cycle or 1 month, 11_Parts B, C: Ongoing treatment with sulfonamides and/or coumarin derivatives (e.g., acenocoumarol, warfarin, phenprocoumon) within 2 weeks (or 5 halflives, whichever is longer) prior to the [68Ga]Ga-DPI-4452 injection and/or [177Lu]Lu DPI 4452 infusion, 12_Parts B, C: Prior EBRT to more than 25% of the bone marrow as judged by the Investigator, 2_Part A: Bladder outflow obstruction or unmanageable urinary incontinence, 3_Part A: Administration of a radiopharmaceutical within a period corresponding to 10 half-lives of the radionuclide used prior to injection of [68Ga]Ga-DPI-4452, 4_Part A: Previous CA IX-targeting treatment, 5_Part A: Ongoing treatment with sulfonamides and/or coumarin derivatives (e.g., acenocoumarol, warfarin, phenprocoumon) within 2 weeks (or 5 half-lives, whichever is longer) prior to the [68Ga]Ga-DPI-4452 injection, 6_part A: Prior external beam radiation therapy (EBRT) to more than 25% of the bone marrow, as judged by the Investigator
研究者
相似试验
进行中（未招募）
1 期
Safety, pharmacokinetics, and efficacy of subcutaneous isatuximab in adults with warm autoimmune hemolytic anemiaWarm autoimmune hemolytic anemiaEUCTR2020-003880-24-BESanofi-Aventis Recherche & Developpement23
进行中（未招募）
1 期
Safety, pharmacokinetics, and efficacy of subcutaneous isatuximab in adults with warm autoimmune hemolytic anemiaWarm autoimmune hemolytic anemiaEUCTR2020-003880-24-HUSanofi-Aventis Recherche & Developpement23
进行中（未招募）
1 期
Safety, pharmacokinetics, and efficacy of subcutaneous isatuximab in adults with warm autoimmune hemolytic anemiaMedDRA version: 20.0Level: PTClassification code 10047822Term: Warm type haemolytic anaemiaSystem Organ Class: 10005329 - Blood and lymphatic system disordersWarm autoimmune hemolytic anemiaEUCTR2020-003880-24-ITSANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT23
进行中（未招募）
1 期
Safety, pharmacokinetics, and efficacy of subcutaneous isatuximab in adults with warm autoimmunehemolytic anemiaWarm autoimmune hemolytic anemiaEUCTR2020-003880-24-DESanofi-Aventis Recherche & Developpement23
进行中（未招募）
1 期
Safety, pharmacokinetics, and efficacy of subcutaneous isatuximab in adults with warm autoimmune hemolytic anemiaWarm autoimmune hemolytic anemiaMedDRA version: 25.0Level: LLTClassification code 10047822Term: Warm type haemolytic anaemiaSystem Organ Class: 100000004851EUCTR2020-003880-24-NLSanofi-Aventis Recherche & Developpement23