CTRI/2023/12/060746尚未招募2 期
A Phase 2 Multicenter, Open-Label, Single-Arm Study to Evaluate theSafety and Efficacy of Oral NRC-2694-A in Combination with Paclitaxel inPatients with Recurrent and/or Metastatic Head and Neck Squamous CellCarcinoma, Who Progressed on or After Immune Checkpoint InhibitorTherapy - NI
ATCO Pharma Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
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
入选标准
- •1. Is willing and capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements.
- •2. Is male or female aged 18 years or older at the time of consent.
- •3. Has histologically confirmed unresectable R/M HNSCC (oral cavity, oropharynx, hypopharynx, and larynx).
- •4. Has documented radiographical progressive disease assessed by the investigator per RECIST v1.1.
- •5. Has a measurable lesion per RECIST v1.1.
- •6. Has ECOG performance status score of =2.
- •7. Must have progressed during or after receiving ICI therapy, such as pembrolizumab or nivolumab. Patients with prior immune-mediated reactions due to ICI therapies (eg, pembrolizumab or nivolumab) and who had recovered prior to study entry will also be eligible.
- •8. Female patients of childbearing potential should have a negative urine test before enrollment. If the urine pregnancy test is positive or gives equivocal results, a serum pregnancy will be required for confirmation.
- •9. Patients of reproductive age must use acceptable methods of contraception throughout the study period and for 30 days following the last dose of investigational product (see Section 6.5.1 for further guidance).
- •10. During screening and at subsequent visits, the investigator should ensure adequate bone marrow reserve (neutrophil count =1500/mm3, platelet count =100,000/mm3, and hemoglobin level 8.0 g/dL), renal function (creatinine clearance =50 mL/min calculated by Cockcroft-Gault formula), liver function (total bilirubin level =1.5 × ULN [except patients with documented Gilbert’s syndrome] and serum transaminase levels =2.5 × ULN or =5 × ULN for liver metastasis and/or obstructive jaundice).
- •11. Must have completed a duration of at least 4 weeks after stopping ICI therapy and must have recovered to grade =1 from all toxicities due to this therapy.
排除标准
- •1. Has cardiac, hepatic, endocrine, pulmonary, or autoimmune disease, interstitial lung disease, renal or psychiatric disorders, not controlled with therapy corresponding to
- •the illness or a condition that contraindicates the use of a taxane or an EGFR inhibitor.
- •2. Has uncontrolled brain metastases. Patients are allowed if brain metastasis has been previously treated with surgery, whole brain irradiation, and/or stereotactic radiosurgery and are considered controlled (controlled by the dose =10 mg/day of
- •prednisone or equivalent) at the time of the first dose of investigational product. Radiological evaluation of brain metastasis will be performed only if the patient has symptoms. For asymptomatic patients, brain imaging during screening is not required.
- •3. Has baseline prolongation of QT/QTc interval (eg, repeated demonstration of a QTc interval >480 milliseconds [CTCAE grade 1] using Fridericia’s QT correction formula).
- •4. Has a history of additional risk factors for Torsade de pointes (eg, heart failure, hypokalemia, family history of long QT syndrome).
- •5. Has had prior cetuximab therapy for recurrent or metastatic disease. Note that cetuximab used concomitantly with radiotherapy or as an induction therapy is acceptable.
- •6. Has received any other EGFR-targeted therapies for recurrent or metastatic disease.
- •7. Currently participating in any clinical trial or receiving investigational therapy on expanded access or compassionate basis.
- •8. Has nasopharyngeal carcinomas or salivary gland cancers.
- •9. Has received investigational products or any other salvage therapy after failure of pembrolizumab/nivolumab therapy.
- •10. Female patient who tested positive for pregnancy.
- •11. Female patient who is breastfeeding or planning to become pregnant, or male patient planning to father a child within the duration of the study.
- •12. Has tested positive for HIV, HBsAg, HCV antibody, or HCV RNA at screening. However, patients who test positive for HCV antibody, but negative for HCV RNA, will be allowed. In addition, patients with controlled HIV, chronic HBV on suppressive antiviral therapy, or a history of HCV infection status post-curative
- •antiviral treatment with an HCV viral load below limit of quantification are permitted to participate (DHHS 2020).
- •13. Has active infection requiring intravenous anti-infective therapy within 7 days prior to Day 1 Cycle 1 or is febrile due to infection.
- •14. Has had major surgery within 4 weeks prior to screening.
- •15. Administered a live attenuated vaccine within 4 weeks prior to Day 1 Cycle 1 or anticipation that such a live attenuated vaccine will be required during the study.
- •16. Has known or suspected hypersensitivity to any components of the formulation used for this investigational product.
- •17. Has concurrent disease or any clinically significant abnormality following the investigator’s review of the screening physical examination findings, 12-lead ECG results, and clinical laboratory tests, which in the judgment of the investigator would
- •interfere with the patient’s participation in this study or evaluation of study results.
- •18. Unable to come for study visits per schedule.
- •19. Has current drug or alcohol abuse.
- •20. Has received prior treatment with paclitaxel or docetaxel for metastatic or recurrent HNSCC. However, prior paclitaxel or docetaxel as a com
研究者
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