EUCTR2021-006804-34-IT进行中（未招募）1 期
A Phase 1b/2a, Open-Label, Multi-Center Study of CyPep-1 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety of CyPep-1 in Patients With Advanced or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC), Melanoma, or Triple-Negative Breast Cancer (TNBC) (CATALYST) - CATALYST
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
- 90
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
- 性别
- All
入选标准
- •General Inclusion Criteria_1_Is 18 years of age or older on the day of signing informed consent; 2_Provides written informed consent and is able to comply with study procedures and assessments; 3. Has measurable disease as determined by the RECIST version (v)1.1; 4. Has at least 1 non-ulcerated, measurable, and accessible lesion for intra-tumoral (IT) injection with a maximum diameter of 5 cm; 5. Is able to provide tissue from a core or excisional biopsy at screening or has an acceptable stored tumor sample available that was collected within 90 days prior to screening; 6. Has an ECOG performance status of 0 or 1; 7. Has a life expectancy =3 months, as determined by the Investigator;8. Female patients of non-childbearing potential must be either surgically sterile ,post-menopausal, defined as spontaneous amenorrhea for at least 2 years, or with follicle-stimulating hormone in the post-menopausal range at screening; 9. Female patients of childbearing potential (defined as <2 years after last menstruation or not surgically sterile) must have a negative serum pregnancy test at screening and agree to use a highly effective method for contraception from the time of signing the informed consent form (ICF) until at least 120 days after the last administration of study treatment. Highly effective methods of contraception are birth control methods with a failure rate of <1% per year when used consistently and correctly. 10. If a male patient is able to father children, he must agree to use 2 acceptable methods of contraception throughout the study . Sperm donation is not recommended from the time of signing the ICF until at least 120 days after the last administration of study treatment; and 11. Has adequate organ function. Specimens must be collected within 72 hours prior to the start of study treatment at Cycle 1 Visit 1.Inclusion Criteria for Arm A_A patient who meets all of the general Inclusion Criteria and the following additional criteria :1. Has histologically confirmed diagnosis of HNSCC; 2. Has advanced or metastatic HNSCC incurable by standard of care therapies; and 3. Has recurred or metastatic HNSCC that has progressed on or failed both platinum-based chemotherapy AND an immune checkpoint inhibitor (ICI) given either sequentially or concurrently. Inclusion Criteria for Arm B_A patient who meets all of the general Inclusion Criteria and the following additional criteria : 1. Has histologically confirmed diagnosis of malignant melanoma; 2. Has advanced or metastatic melanoma incurable by standard of care therapies; and 3. Has failed or progressed on or after treatment with a checkpoint inhibitor administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies. Inclusion Criteria for Arm C_A patient who meets all of the general Inclusion Criteria and the following additional criteria :1. Has histologically confirmed diagnosis of TNBC;2. Has advanced or metastatic TNBC incurable by standard of care therapies; and 3. Has failed or progressed on or after treatment with a checkpoint inhibitor administered either as monotherapy or in combination with other therapies OR has received prior systemic therapy with either an anthracycline- or taxane containing regimen .
- •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 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 45
排除标准
- •1. Has only non-palpable cutaneous infiltrations ; 2. Had anti-cancer therapy within 4 weeks prior to the first dose of study treatment; 3. Has participated in a clinical trial and received an investigational therapy within 30 days prior to the first dose of study treatment; 4. Has received or will receive a live or live attenuated vaccine within 30 days prior to the first dose of study treatment; 5. Has tested positive for severe acute respiratory syndrome coronavirus 2 infection within 14 days prior to the Screening Visit; 6. Has had a major surgical procedure within 14 days prior to the first dose of CyPep-1; 7. Is expected to require a systemic or localized anti-neoplastic therapy during participation in this study, ; 8. Is pregnant or breastfeeding; 9. Has clinical evidence of a secondary malignancy actively progressing or requiring active treatment other than curative therapies for early stage carcinomas or non-melanoma skin cancer; 10. Has had any autoimmune disease requiring immunosuppressive therapy within 2 years prior to the first dose of study treatment;11.Has a condition requiring continuous systemic treatment with either corticosteroids or other immunosuppressive agents within 2 weeks prior to the first dose of study treatment; 12. Has abnormal or clinically significant coagulation parameters as determined by the Investigator ; 13. Has a significant history or clinical manifestation of any allergic disorders and/or Quincke's edema (as determined by the Investigator) capable of significantly altering the absorption of drugs, of constituting a risk when taking CyPep-1 or pembrolizumab, or of interfering with the interpretation of the data; 14. Has a known hypersensitivity to any component of CyPep-1 or pembrolizumab; 15. Has a history of adverse reactions from treatment with ICIs, including pembrolizumab, which resulted in discontinuation of ICI or pembrolizumab or has ongoing pembrolizumab-related toxicity event(s) as per treatment-limiting toxicity definitions ; 16. Has an active infection requiring systemic therapy; 17. Has a known history of Hepatitis B or know active Hepatitis C virus infection; 18. Has had radiotherapy within 2 weeks prior to the first dose of study treatment, is in recovery from radiation toxicity, or has had radiation pneumonitis;19.Has a history of non-infectious pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease; 20. Has had a prior allogeneic tissue/solid organ transplant, stem cell, or bone marrow transplant; 21. Has active human immunodeficiency virus (HIV). Patient is eligible when on stable anti-retroviral therapy for at least 4 weeks prior to screening,. HIV-infected patients with a history of Kaposi sarcoma and/or Multicentric Castleman Disease will be excluded; 22. Has a central nervous system (CNS) metastasis that is symptomatic, progressing, or that requires current therapy ; 23. Has a QTcF >480 ms at screening, history of long or short QT syndrome, Brugada syndrome, QTc prolongation, or Torsade de Pointes or 24. Has a history of or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or make participation in the study not in the best interest of the patient, in the opinion of the Investigator.
研究者
相似试验
撤回
2 期
A Phase 1b/2a, Open-Label, Multi-Center Study of CyPep-1 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety of CyPep-1 in Patients With Advanced or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC), Melanoma, or Triple-Negative Breast Cancer (TNBC) (CATALYST)head and neck cancer1002765510040900breast cancerSkin cancerNL-OMON51302Cytovation ASA12
进行中（未招募）
1 期
Combination Study of RMC-4630 and Sotorasib for NSCLC Subjects with KRASG12C Mutation After Failure of Prior Standard Therapieson-Small Cell Lung Cancer Subjects with KRASG12C Mutation After Failure of Prior Standard TherapiesMedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2021-003254-23-DERevolution Medicines, Inc.46
进行中（未招募）
1 期
Combination Study of RMC-4630 and Sotorasib for NSCLC Subjects with KRASG12C Mutation After Failure of Prior Standard TherapiesEUCTR2021-003254-23-FRRevolution Medicines, Inc.46
进行中（未招募）
1 期
Combination Study of RMC-4630 and Sotorasib for NSCLC Subjects with KRASG12C Mutation After Failure of Prior Standard Therapieson-Small Cell Lung Cancer Subjects with KRASG12C Mutation After Failure of Prior Standard TherapiesMedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2021-003254-23-ESRevolution Medicines, Inc.46
进行中（未招募）
不适用
A Phase 1b/2a, Open-Label, Multi-Center Study of AV-951 in Combination with Paclitaxel in Subjects with Advanced or Metastatic Breast CancerAdvanced or metastatic breast cancerMedDRA version: 9.1Level: LLTClassification code 10027475Term: Metastatic breast cancerEUCTR2008-002109-38-DEAVEO Pharmaceuticals, Inc.84