临床试验/NCT04901741

NCT04901741尚未招募2 期

An Open-label Phase 2 Study of Olaptesed Pegol (NOX-A12) Combined With Pembrolizumab and Nanoliposomal Irinotecan/5-FU/Leucovorin or Gemcitabine/Nab-paclitaxel in Microsatellite-stable Metastatic Pancreatic Cancer Patients

TME Pharma AG0 个研究点目标入组 60 人开始时间: 2026年1月1日最近更新: 2025年6月27日

适应症

干预措施

试验速览

阶段: 2 期
状态: 尚未招募
发起方
入组人数: 60
主要终点: Go/no-go decision for a randomized expansion study

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验相关资讯

研究概览

简要总结

The purpose of this study is to provide a go/no-go decision for a randomized expansion study by assessing the disease control rate (DCR) at 6 weeks for the combination of olaptesed pegol on top of pembrolizumab and (Arm 1) nanoliposomal irinotecan, 5-FU and leucovorin or (Arm 2) gemcitabine and nab-paclitaxel, to assess safety and tolerability and time-to-event endpoints.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Single (Participant)

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patient with confirmed microsatellite-stable tumor pathology, if data available
•Patient with histologically or cytologically confirmed primary metastatic adenocarcinoma of the pancreas, who
•Arm 1: stopped first-line treatment with gemcitabine/nab-paclitaxel after documented objective radiographic progression OR
•Arm 2: stopped first-line treatment with FOLFIRINOX or modified FOLFIRINOX after documented objective radiographic progression
•Measurable disease based on RECIST 1.1 as determined by the investigational site
•Estimated minimum life expectancy 3 months
•Eastern Cooperative Oncology Group (ECOG) performance score 0 to 1
•Adequate organ function laboratory values within the ranges specified: Serum albumin ≥ 3.0 g/dL; Hematological system: Hemoglobin (Hb) ≥ 9.0 g/dL or ≥5.6 mmol/L, Absolute neutrophil count (ANC) ≥ 1,500/mm³, Platelets ≥ 100,000/mm³; Renal system: Creatinine ≤ 1.5 x ULN OR eGFR ≥30 mL/min for patient with creatinine levels >1.5 × institutional ULN; Hepatic system: Total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ULN for patients with total bilirubin levels >1.5 × ULN, ALT and AST ≤ 2.5 x ULN (≤5 × ULN for patients with liver metastases); Coagulation: INR OR PT ≤ 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants, aPTT ≤ 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants

排除标准

•Prior systemic anti-cancer therapy including investigational agents within 4 weeks or 5 half-lives, whichever is shorter, prior to treatment.
•Patients must have recovered from all AEs due to previous therapies to ≤ Grade 1 or baseline. Patients with ≤ Grade 2 neuropathy may be eligible. Patients with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible.
•If the patient had major surgery, the patient must have recovered adequately from the procedure and/or any complications from the surgery prior to starting study intervention
•Prior radiotherapy within 2 weeks of start of study treatment. Patients must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
•Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137) and discontinued from that treatment due to a Grade 3 or higher irAE
•Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug
•Received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention. Administration of killed vaccines are allowed
•Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
•History of (non-infectious) pneumonitis / interstitial lung disease that required steroids or current pneumonitis / interstitial lung disease
•Active infection requiring systemic therapy
•Known additional malignancy that is progressing or has required active treatment within the past 2 years.
•Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
•Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment
•Previous allogeneic tissue/solid organ transplant

研究组 & 干预措施

Arm 1: olaptesed pegol + pembrolizumab + nanoliposomal irinotecan + 5-FU + LV

Experimental

干预措施: Olaptesed pegol (Drug)

Arm 1: olaptesed pegol + pembrolizumab + nanoliposomal irinotecan + 5-FU + LV

Experimental

干预措施: Pembrolizumab (Drug)

Arm 2: olaptesed pegol + pembrolizumab + gemcitabine + nab-paclitaxel

Experimental

干预措施: Olaptesed pegol (Drug)

Arm 2: olaptesed pegol + pembrolizumab + gemcitabine + nab-paclitaxel

Experimental

干预措施: Pembrolizumab (Drug)

结局指标

主要结局

Go/no-go decision for a randomized expansion study

时间窗: until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab

Assessment of the disease control rate (DCR) at 6 weeks for the combination of olaptesed pegol on top of pembrolizumab and (Arm 1) nanoliposomal irinotecan, 5-FU and leucovorin or (Arm 2) gemcitabine and nab-paclitaxel

次要结局

Safety and tolerability(until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab)
Progression free survival (PFS)(until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab)
DCR at 12 weeks(until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab)
Overall response rate (ORR)(until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab)
median Overall survival (mOS)(until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab)
Duration of response (DOR)(until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab)
Time-to-best overall response (TBOR)(until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab)
Time-to-next-anticancer-treatment (TTNT)(until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab)

研究者

发起方

TME Pharma AG

申办方类型

Industry

责任方

Sponsor

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