CTIS2024-510799-19-00进行中（未招募）1 期
A Phase 1b/2a Multicenter, Open-label, Dose Escalation Study to Determine the Maximum Tolerated Dose, Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of CC-220 as Monotherapy and in Combination with Other Treatments in Subjects with Multiple Myeloma - CC-220-MM-001
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 498
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
- •Subject is =18 years of age at the time of signing the ICF., Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2, Please refer to the protocol page 68 for a discussion on the criteria for a female of childbearing potential., Please refer to the protocol page 68 for a discussion on the conditions of practicing true abstinence for male subjects., Males must agree to refrain from donating sperm while on study treatment, during dose interruptions and for at least 90 days following last dose of study treatment., All subjects must agree to refrain from donating blood while on study treatment, during dose interruptions and for at least 28 days following the last dose of study treatment., All male and female subjects must follow all requirements defined in the Pregnancy Prevention Program. See Appendix D of the protocol for CC-220 Pregnancy Prevention Plan for Subjects in Clinical Trials, Subjects in Cohort D must have received prior treatment with at least 2 consecutive cycles of a glucocorticoid-containing regimen., Subjects in Cohort D must be refractory to an ID agent, a proteasome inhibitor, a glucocorticoid and a CD38 antibody., Subjects in Cohort I must have received prior treatment with a BCMA targeted therapy., Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted, Subject is willing and able to adhere to the study visit schedule and other protocol requirements, All subjects in RRMM cohorts must have a documented diagnosis of MM and have measurable disease defined as: a. M-protein (serum and/or urine protein electrophoresis (sPEP or uPEP)): sPEP =0.5 g/dL or uPEP = 200 mg/24 hours and/or b. Light chain MM without measurable disease in the serum or urine: serum immunoglobulin free light chain = 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa lambda free light chain ratio, Subjects in Cohorts A,B,C, E, G1 and G2 must have received at least 2 prior myeloma regimens (note: induction with or without bone marrow transplant and with or without maintenance therapy is considered one regimen). Subjects in Cohort F must have received at least 1 prior myeloma regimen. Subjects in Cohorts D and I must have received at least 3 prior myeloma regimens., All subjects in RRMM cohorts must have received prior treatment with at least 2 consecutive cycles of a lenalidomide or pomalidomidecontaining regimen. Subjects in Cohort D must have received prior treatment with at least 2 consecutive cycles of a lenalidomide-containing regimen and at least 2 consecutive cycles of a pomalidomide-containing regimen., All subjects in RRMM cohorts must have received prior treatment with at least 2 consecutive cycles of a proteasome inhibitor or a proteasome inhibitor-containing regimen, For Part 2 RRMM cohorts (Cohorts C,D,and I) all subjects must have received prior treatment with at least 2 consecutive cycles of a CD38 antibody or a CD38 antibody-containing regimen, All subjects in RRMM cohorts must have documented disease progression on or within 60 days from the last dose of their last myeloma therapy. Subjects who had CAR T therapy as their last myeloma therapy must have documented disease progression.
排除标准
- •Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study, Subject has a history of anaphylaxis or hypersensitivity to thalidomide, lenalidomide, pomalidomide, DEX, daratumumab (for Cohorts E and K), bortezomib (for Cohorts F, J1 and J2) or carfilzomib (for Cohorts G1 and G2). Subject has known or suspected hypersensitivity to the excipients contained in the formulation of CC- 220, DEX, daratumumab (for Cohorts E and K), bortezomib (for Cohorts F, J1 and J2) or carfilzomib (for Cohorts G1 and G2)., Contraindications to the other treatment regimens, as per local prescribing information, Subject has received any of the following within the last 14 days of initiating IP: ·Plasmapheresis ·Major surgery (as defined by the Investigator) ·Radiation therapy other than local therapy for MM associated bone lesions ·Use of any systemic myeloma drug therapy, Subject has been treated with an investigational agent (ie, an agent not commercially available) within 28 days or 5 half-lives (whichever is longer) of initiating IP. Not applicable for subjects who had CAR T as last prior regimen., Subject has any one of the following: ·Clinically significant abnormal electrocardiogram (ECG) finding at Screening ·Congestive heart failure (New York Heart Association Class III or IV) ·Myocardial infarction within 12 months prior to starting IP ·Unstable or poorly controlled angina pectoris, including the Prinzmetal variant of angina pectoris, Subject has current or prior use of immunosuppressive medication within 14 days prior to the first dose of IP. The following are exceptions to this criterion: ·Intranasal, inhaled, topical or local steroid injections (eg, intra-articular injection) ·Systemic corticosteroids at physiologic doses that do not exceed 10 mg/day of prednisone or equivalent ·Steroids as premedication for hypersensitivity reactions (eg, computed tomography [CT] scan premedication), Subject has taken a strong inhibitor or inducer of CYP3A4/5 including grapefruit, St. John's Wort or related products within two weeks prior to dosing and during the course of study., Subject known to test positive for human immunodeficiency virus (HIV), chronic or active hepatitis B, or active hepatitis A or C, Subject is unable or unwilling to undergo protocol required thromboembolism prophylaxis, Subject is a female who is pregnant, nursing or breastfeeding, or who intends to become pregnant during the participation in the study, Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study, Subject has any condition that confounds the ability to interpret data from the study, Subject has nonsecretory multiple myeloma, Subjects with Plasma Cell leukemia or amyloidosis, Any of the following laboratory abnormalities ·Absolute neutrophil count (ANC) <1,000/µL ·Platelet count <75,000/µL for Part 1. For Part 2; platelet count < 75,000/µL for subjects in whom < 50% of bone marrow nucleated cells are plasma cells; otherwise platelet count < 50,000/µL(transfusions are not permitted to achieve minimum platelet counts) ·Corrected serum calcium > 13.5 mg/dL (> 3.4 mmol/L) ·Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) or serum glutamic pyruvic transaminase (SGPT)/alanine aminotransferase (ALT) =2.0 x upper limit of normal (ULN) ·Serum total bil
研究者
相似试验
进行中（未招募）
1 期
A study on NKTR-255 in combination with Cetuximab as salvage treatment for Solid TumorsRelapsed or refractory (R/R) head and neck squamous cell carcinoma (HNSCC) or colorectal carcinoma (CRC)MedDRA version: 20.0Level: LLTClassification code 10009963Term: Colon carcinoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10007336Term: Carcinoma colon recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 22.0Level: LLTClassification code 10082179Term: Squamous cell carcinoma of head and neck metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: PTClassification code 10060121Term: Squamous cell carcinoma of head and neckSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2021-002177-25-ESektar Therapeutics78
进行中（未招募）
1 期
A study on NKTR-255 in combination with Cetuximab as salvage treatment for Solid TumorsRelapsed or refractory (R/R) head and neck squamous cell carcinoma (HNSCC) or colorectal carcinoma (CRC)MedDRA version: 22.0Level: LLTClassification code 10082179Term: Squamous cell carcinoma of head and neck metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10009963Term: Colon carcinoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10007336Term: Carcinoma colon recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: PTClassification code 10060121Term: Squamous cell carcinoma of head and neckSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2021-002177-25-ITEKTAR THERAPEUTICS78
已完成
1 期
A Phase 1b/2a Multicenter, Open-label, Dose-escalation Study to Determine the Maximum Tolerated Dose, Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of CC-220 as Monotherapy and in Combination with Other Treatments in Subjects with Multiple MyelomaMultiple myeloma (MM)JPRN-jRCT2080224873Bristol-Myers Squibb K.K.41
进行中（未招募）
1 期
A study of Trastuzumab Deruxtecan to assess its safety, tolerability, immune response, and inhibition of tumor activity when given alone or in combination with other agents in patients with HER2 Overexpressing Gastric CancerEUCTR2019-004483-22-DEAstraZeneca AB250
进行中（未招募）
1 期
A study of Trastuzumab Deruxtecan to assess its safety, tolerability, immune response, and inhibition of tumor activity when given alone or in combination with other agents in patients with HER2 OverexpressingGastric CancerPatients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing gastric cancerMedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-004483-22-ITASTRAZENECA AB220