EUCTR2020-004662-19-NL进行中（未招募）1 期
A PHASE 2 STUDY OF ALX148 IN COMBINATION WITH PEMBROLIZUMAB AND CHEMOTHERAPY IN PATIENTS WITH ADVANCED HEAD AND NECK SQUAMOUS CELL CARCINOMA (ASPEN-04) - ASPEN-04
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 162
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients with metastatic or unresectable, recurrent head and neck squamous cell carcinoma (HNSCC) who have not received prior systemic therapy for their advanced disease. PD-L1 status as defined by combined positive score (CPS) and as assessed by an FDA-approved test using the 22C3 antibody must be available.
- •Patients cannot have received prior systemic therapy for the treatment of metastatic or recurrent disease.
- •Patients can have received prior systemic therapy for the treatment of locoregionally advanced disease if it was completed more than 6 months prior to signing informed consent.
- •2. Patients must have at least one measurable lesion as defined by RECIST version 1.1.
- •3. Adequate bone marrow function.
- •4. Adequate renal function (estimated creatinine clearance by Cockroft-Gault equation of = 60 mL/min.).
- •5. Adequate liver function.
- •6. Age =18 years, except in regions in which the minimum age for subject participation is >18 years.
- •7. INR or PT and PTT <1.5X ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants.
- •8. ECOG performance status 0 or 1.
- •9. Participants with oropharyngeal carcinoma must have available results from testing of human papillomavirus (HPV) (p16) status.
- •10. Participants must have recovered from all AEs due to previous therapies, procedures, and surgeries to baseline or =Grade 1 per NCI CTCAE v. 5.0 except for AEs not constituting a safety risk by Investigator judgment. Participants with =Grade 2 neuropathy may be eligible.
- •11. Available core or incisional biopsy sample prior to study entry preferably taken after the most recent therapy for HNSCC taken from either an unresectable recurrent lesion or a metastatic lesion for central confirmation of PD-L1 CPS and evaluation of other biomarkers. Fine needle aspirates are not acceptable.
- •12. Serum pregnancy test (for females of childbearing potential) negative at screening.
- •13. Male and female patients of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 120 days after the last dose of assigned treatment and at least 6 months (or longer if required by local regulation) after the last dose of chemotherapy, whichever is later.
- •14. Evidence of a personally signed and dated informed consent document, from a patient with the capacity to consent for themselves or from a legal representative, indicating that the patient or legal representative has been informed of all pertinent aspects of the study before any study-specific activity is performed.
- •15. Patients who are willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other procedures.
- •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 81
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 81
排除标准
- •1. Patients with disease suitable for local therapy with curative intent.
- •2. Patients with progressive disease within 6 months of completion of curatively intended systemic therapy for the treatment of locoregionally advanced HNSCC.
- •3. Patients with nasopharyngeal carcinoma (NPC).
- •4. Patients with known symptomatic CNS metastases requiring steroids or with leptomeningeal disease.
- •5. Has a history of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease.
- •6. Prior radiotherapy within 2 weeks of start of study treatment.
- •7. Prior treatment with any anti-CD47 or anti-SIRPa agent.
- •8. Prior treatment with a PD-1 or 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).
- •9. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug.
- •10. Has a diagnosis of complete dihydropyrimidine dehydrogenase (DPD) deficiency. Testing for DPD status is required for sites/regions in which such testing is standard of care (such as in the United Kingdom).
- •11. Has an active autoimmune disease that has required systemic treatment in past 2 years.
- •12. History of autoimmune hemolytic anemia, autoimmune thrombocytopenia, or hemolytic transfusion reaction.
- •13. Patients with intolerance to or who have had a severe allergic or anaphylactic reaction to antibodies or infused therapeutic proteins or patients who have had a severe allergic or anaphylactic reaction to any of the substances included in the study drugs.
- •14. Patients with significant hearing impairment.
- •15. Any experimental antibodies or live vaccines in the last 30 days prior to the first dose of study drug.
- •16. Patients with active, uncontrolled, clinically significant bacterial, fungal, or viral infection.
- •17. Has an active infection requiring systemic therapy.
- •18. Has had an allogeneic tissue/solid organ transplant.
- •19. Any of the following in the previous 6 months: myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, NYHA Class II or greater congestive heart failure, cerebrovascular accident, or transient ischemic attack, deep venous thrombosis, arterial thrombosis, symptomatic pulmonary embolism, or any other significant thromboembolism. Any major surgery within 28 days prior to enrollment.
- •20. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
- •21. Diagnosis of any other malignancy within the last 3 years prior to enrollment except for adequately treated non-melanomatous skin cancer, or carcinoma in situ that have undergone potentially curative therapy.
- •22. Other severe acute or chronic medical or psychiatric condition.
- •23. Patients who are pregnant or breastfeeding.
研究者
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