A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER)

计划状态

招聘

阶段

第 1 阶段

允许先接受免疫治疗

没有

CRC 指导的试验

药物

Carboplatin, cisplatin, Docetaxel, Nivolumab, Pemetrexed, TSR-022, TSR-033, TSR-042

标签

MSI-H/ MMRd、MSS/ MMRp
地点 位置状态
美国
GSK Investigational Site
亚利桑那州古德伊尔 85338
已完成
GSK Investigational Site
亚利桑那州斯科茨代尔 85258
已完成
GSK Investigational Site
亚利桑那州图森 85704
已完成
GSK Investigational Site
Tucson, Arizona 85711
已完成
GSK Investigational Site
Encinitas, California 92024
招聘
GSK Investigational Site
Fountain Valley, California 92708
招聘
GSK Investigational Site
加利福尼亚州洛杉矶 90024
招聘
GSK Investigational Site
加利福尼亚州洛杉矶 90025
招聘
GSK Investigational Site
San Marcos, California 92069
招聘
GSK Investigational Site
Whittier, California 90606
招聘
GSK Investigational Site
科罗拉多州奥罗拉 80012
招聘
GSK Investigational Site
科罗拉多州奥罗拉 80045
招聘
GSK Investigational Site
科罗拉多州丹佛 80218
已完成
GSK Investigational Site
科罗拉多州丹佛 80218
招聘
GSK Investigational Site
New Haven, Connecticut 06511
招聘
GSK Investigational Site
哥伦比亚特区华盛顿 20007
招聘
GSK Investigational Site
佛罗里达州杰克逊维尔 32224
已完成
GSK Investigational Site
佛罗里达州迈阿密海滩 33140
已完成
GSK Investigational Site
佛罗里达州萨拉索塔 34232
招聘
GSK Investigational Site
佛罗里达州坦帕市 33612
招聘
GSK Investigational Site
佐治亚州亚特兰大 30322
已完成
GSK Investigational Site
Augusta, Georgia 30912
已完成
GSK Investigational Site
Arlington Heights, Illinois 60005
招聘
GSK Investigational Site
伊利诺伊州芝加哥 60637
招聘
GSK Investigational Site
伊利诺伊州奈尔斯 60714
招聘
GSK Investigational Site
Iowa City, Iowa 52242-1009
招聘
GSK Investigational Site
Wichita, Kansas 67214
已完成
GSK Investigational Site
肯塔基州路易斯维尔 40202
已完成
GSK Investigational Site
Pikeville, Kentucky 41501
招聘
GSK Investigational Site
Rockville, Maryland 20850
招聘
GSK Investigational Site
马萨诸塞州波士顿 02114
招聘
GSK Investigational Site
密歇根州底特律 48202
已完成
GSK Investigational Site
明尼苏达州罗切斯特 55905
已完成
GSK Investigational Site
新泽西州哈肯萨克 07601
已完成
GSK Investigational Site
纽约州布朗克斯 10461
招聘
GSK Investigational Site
纽约州纽约市 10016
招聘
GSK Investigational Site
俄亥俄州辛辛那提 45242
已完成
GSK Investigational Site
Cleveland, Ohio 44106
招聘
GSK Investigational Site
Toledo, Ohio 43623
招聘
GSK Investigational Site
俄勒冈州尤金 97401
招聘
GSK Investigational Site
Portland, Oregon 97213-2982
已完成
GSK Investigational Site
Bethlehem, Pennsylvania 18015
已完成
GSK Investigational Site
Pittsburgh, Pennsylvania 15213-2584
招聘
GSK Investigational Site
南卡罗来纳州查尔斯顿 29425
招聘
GSK Investigational Site
南卡罗来纳州格林维尔 29605
已完成
GSK Investigational Site
田纳西州纳什维尔 37203
招聘
GSK Investigational Site
德克萨斯州奥斯汀 78705
已完成
GSK Investigational Site
德克萨斯州达拉斯 75246
招聘
GSK Investigational Site
德克萨斯州沃斯堡 76104
已完成
GSK Investigational Site
德克萨斯州休斯顿 77030
招聘
GSK Investigational Site
德克萨斯州休斯顿 77030
招聘
GSK Investigational Site
Longview, Texas 75601
招聘
GSK Investigational Site
McAllen, Texas 78503-1298
招聘
GSK Investigational Site
德克萨斯州圣安东尼奥 78229
已完成
GSK Investigational Site
Temple, Texas 76508
已完成
GSK Investigational Site
得克萨斯州泰勒 75702
招聘
GSK Investigational Site
Weslaco, Texas 78596
招聘
GSK Investigational Site
Fairfax, Virginia 8613
招聘
GSK Investigational Site
Kennewick, Washington 99336
招聘
GSK Investigational Site
Puyallup, Washington 98373
招聘
GSK Investigational Site
华盛顿州塔科马 98405
招聘
GSK Investigational Site
威斯康星州麦迪逊 53792
已完成
大韩民国
GSK Investigational Site
Daegu 41931
招聘
GSK Investigational Site
Seongnam-si, Gyeonggi-do 13620
招聘
GSK Investigational Site
Seoul 02841
招聘
GSK Investigational Site
首尔 03722
招聘
GSK Investigational Site
首尔 06351
招聘
GSK Investigational Site
Seoul 7061
招聘
西班牙
GSK Investigational Site
Palma de Mallorca, Islas Baleares 07120
招聘
GSK Investigational Site
Madrid, Navarra 28027
招聘
GSK Investigational Site
Barcelona 08017
招聘
GSK Investigational Site
巴塞罗那 08035
招聘
GSK Investigational Site
Barcelona 8028
招聘
GSK Investigational Site
Girona 17007
招聘
GSK Investigational Site
Jerez de la Frontera 11407
招聘
GSK Investigational Site
L'Hospitalet De Llobregat 08908
招聘
GSK Investigational Site
Las Palmas De Gran Canaria 35016
招聘
GSK Investigational Site
马德里 28040
招聘
GSK Investigational Site
马德里 28041
招聘
GSK Investigational Site
马德里 28046
招聘
GSK Investigational Site
Majadahonda (Madrid) 28222
招聘
GSK Investigational Site
Málaga 29010
招聘
GSK Investigational Site
潘普洛纳 31008
已完成
GSK Investigational Site
Santander 39008
招聘
GSK Investigational Site
塞维利亚 41013
招聘
GSK Investigational Site
巴伦西亚 46010
招聘
GSK Investigational Site
巴伦西亚 46026
招聘

联系方式

US GSK Clinical Trials Call Cente
联系方式
877-379-3718 GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center
联系方式
+44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

纳入标准

纳入标准

Participant is at least 18 years of age.
Female participants of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the date of the first dose of study medication or be of non-childbearing potential.
Participant has an ECOG performance status of less than or equal to (=)18 years old, is able to understand the study procedures, and agrees to participate in the study by providing written informed consent which includes compliance with the requirements and restrictions listed in the Informed consent form (ICF) and protocol.
Participant has histologically or cytologically proven advanced or metastatic NSCLC, and only squamous or non-squamous cell carcinoma.
Participant has received no more than 2 prior lines of therapy for advanced or metastatic disease, which must only include a platinum-based (eg, cisplatin, carboplatin) doublet chemotherapy regimen and an anti-PD-1 or anti-PD-L1 antibody (no other biologic agents alone or in combination; novel combinations are not allowed). Participants previously treated with targeted therapies, including angiogenesis inhibitors (eg, bevacizumab, ramucirumab, lenvatinib), are not eligible.
Participant has measurable disease, that is, presenting with at least 1 measurable lesion per RECIST v1.1 as determined by the local site Investigator/radiology assessment. Target lesions situated in a previously irradiated area are considered measurable if disease progression has been demonstrated in such lesions and if there are other target lesions. If there is only 1 target lesion that was previously irradiated, the participant is not eligible.
Participant has documented radiological disease progression on prior platinum-based chemotherapy and on prior anti-PD-1 or anti-PD-L1 therapy according to RECIST v1.1.
Participant agrees to submit an archival formalin fixed paraffin embedded (FFPE) tumor tissue specimen that was collected on or after diagnosis of metastatic disease from location(s) not irradiated prior to biopsy. Both tissue block and freshly cut slides are acceptable. If archival tissue is not available, the participant must undergo biopsy prior to study entry.
Participant has an ECOG performance status score of 0 or 1.
Participant has a life expectancy of at least 3 months and is anticipated to be able to complete 4 cycles of docetaxel treatment.
Participant has adequate organ function as defined in the protocol
Contraceptive use by male and female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Inclusion Criteria for Participants in Part 2 Cohort F

Histologically confirmed locally advanced or metastatic and/or unresectable Hepatocellcular Carcinoma (HCC) a Barcelona Clinic Liver Cancer Stage B or C b Cirrhosis grade of Child-Pugh Class A
No prior systemic therapy for HCC
Documented HBV testing at screening, including hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAB) and hepatitis B core antibody (HBcAb). Participants with a positive HBsAg will require negative hepatitis B virus (HBV) DNA testing at screening.

a Participants with chronic HBV infection (HBsAg +) are required to be receiving effective antiviral therapy (i.e., with Tenofovir or Entecavir) for at least 14 days with willingness to continue for the length of the study and have HBV deoxyribonucleic acid (DNA) less than 100 International Units Per Milliliter (IU/mL) within 28 days prior to initiation of study treatment.

b Participants with a negative (HBsAg) and positive HBcAb result are eligible only if HBV DNA is negative (Past HBV participants).

Documented hepatitis C virus (HCV) antibody testing conducted at screening. If HCV antibody is positive, then hepatitis C virus ribonucleic acid (HCV ribonucleic acid (RNA) must be negative. Participants with recently treated HCV prior to study start must be greater than (>)12 weeks from final HCV treatment.
Must have measurable disease, defined as at least one tumor lesion that can be accurately measured according to RECIST v1.1

Participant agrees to submit an archival FFPE tumor tissue specimen that was collected on or after diagnosis of metastatic disease from location(s) not irradiated prior to biopsy. Both tissue block and freshly cut slides are acceptable. If archival tissue is not available, the participant must undergo biopsy prior to study entry.

a. Participants are also encouraged, but not required, to have a fresh tumor tissue biopsy of a primary or metastatic tumor prior to dosing (samples will be used to enable biomarker analysis).

International normalized ratio (INR) or prothrombin time (PT) <= 2× upper limit of normal (ULN) unless participant is receiving anticoagulant therapy as long as PT or partial thromboplastin (PTT) is within therapeutic range of intended use of anticoagulants. Activated partial thromboplastin time (aPTT) =)3 immune-related AE with prior immunotherapy, with the exception of non-clinically significant lab abnormalities.
Participant has known uncontrolled central nervous system (CNS) metastases and/or carcinomatous meningitis.
Participant has a known additional malignancy that progressed or required active treatment within the last 2 years. Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen may be included only after discussion with the Medical Monitor.
Participant is considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active infection requiring systemic therapy.
Participant is pregnant or breastfeeding or expecting to conceive children within the projected duration of the study, starting with the Screening Visit through 150 days after the last dose of study treatment.
Participant has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.

排除标准

Exclusion Criteria for Participants in Part 2 Cohort D

A participant with negative (as determined by Central Testing Lab) or unevaluable TIM-3 expression from tissue obtained prior to study entry will not be eligible for the study.
Participant has received prior therapy as defined below:
Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agent that resulted in permanent discontinuation due to an AE.
Prior treatment with an anti-lymphocyte activation gene (LAG)-3 or anti-TIM-3.
Radiologic or clinical progression <= 8 weeks after initiation of prior anti-PD-1 or anti-PD-L1 antibody.
Participants with known epidermal growth factor receptor (EGFR) mutation, anaplastic lymphoma kinase (ALK) translocation, or receptor tyrosine kinase (ROS1) mutation.
Participant has received a vaccine other than a vaccine against severe acute respiratory syndrome (SARS)-coronavirus 2 (CoV-2) infection ("Coronavirus Disease 2019" [COVID-19]) within 7 days of planned start of study therapy. The use of all COVID-19 vaccines is allowed, with the exception of COVID-19 vaccines using the recombinant adenoviral vector platform within 30 days of planned start of study therapy. If a COVID-19 vaccine using this platform is to be administered within 30 days of planned start of study therapy, this must first be discussed with and approved by the Sponsor's Medical Monitor.

Exclusion Criteria for Participants in Part 2 Cohort E

Participant has been previously treated with an anti PD 1, anti PD L1, or anti PD L2 agent that resulted in permanent discontinuation due to an AE
Participant has been previously treated with an anti TIM-3 or anti cytotoxic T lymphocyte-associated protein 4 (CTLA 4) agent or docetaxel.
Participant has a documented sensitizing EGFR, ALK, or ROS-1 mutation. Participants whose tumors have not been tested for these driver mutations and therefore who have unknown driver mutation status are not eligible. Participants with squamous histology do not need to be tested for these driver mutations.
Participant had radiological or clinical disease progression (that is [ie,] worsening performance status, clinical symptoms, and laboratory data) 30 Gray (Gy) within 6 months prior to the first dose of study treatment.
Participant has completed palliative radiotherapy within 7 days prior to the first dose of study treatment.
Participant has an additional malignancy or a history of prior malignancy, with the exception of adequately treated basal or squamous skin cancer, cervical carcinoma in situ, or bladder carcinoma in situ without evidence of disease, or had a malignancy treated with curative intent and with no evidence of disease recurrence for 5 years since the initiation of that therapy.
Participant has known new or progressive brain metastases and/or leptomeningeal metastases. Participants who have received prior therapy for their brain metastases and have radiologically stable central nervous system disease may participate, provided they are neurologically stable for at least 4 weeks before study entry and are off corticosteroids within 3 days prior to the first dose of study treatment.
Participant has tested positive for the following at Screening or within 3 months before the first dose of study treatment:
Presence of hepatitis B surface antigen.
Presence of hepatitis C antibody in the absence of an Ribonucleic acid (RNA) test for hepatitis C virus.
Participant has known human immunodeficiency virus (HIV) (positive for HIV 1 or HIV 2 antibodies).
Participant has active autoimmune disease that required systemic treatment in the past 2 years, is immunocompromised in the opinion of the Investigator, or is receiving systemic immunosuppressive treatment. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy of prednisone, or equivalent, for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
Participant has received systemic steroid therapy within 3 days prior to the first dose of the study treatment or is receiving any other form of immunosuppressive medication. Replacement therapy is not considered a form of systemic therapy. Use of inhaled corticosteroids, local steroid injection, or steroid eye drops is allowed.
Participant has current interstitial lung disease, current pneumonitis, or a history of pneumonitis that required the use of glucocorticoids to assist with management. Lymphangitic spread of the NSCLC is not exclusionary.
Participant does not meet requirements per local prescribing guidelines for receiving treatment with docetaxel, including severe hypersensitivity reactions to drugs formulated with polysorbate 80.
Participant has received prior anticancer therapy (chemotherapy, targeted therapies, radiotherapy, or immunotherapy) within 21 days, or less than 5 times the half life of the most recent therapy prior to study Day 1, whichever is shorter.

Exclusion Criteria for Participants in Part 2 Cohort F

Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC
Participant must not have had major surgery <= 3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects
Participants must not have received investigational therapy <= 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior to initiating protocol therapy.
Active or untreated central nervous system (CNS) and leptomeningeal metastases
Prior therapy with any medication targeting PD-1, PD-L1, or TIM-3
Participant must not have a known hypersensitivity to TSR-042 and TSR-022 components or excipients.
Participants with active malignancy (other than HCC) or a prior malignancy within the past 2 years are excluded. Participants with completely resected cutaneous melanoma (early stage), basal cell carcinoma, cutaneous squamous cell carcinoma, cervical carcinoma in-situ, breast carcinoma in-situ, and localized prostate cancer are eligible.
Participant must not have serious, uncontrolled medical disorder, or nonmalignant systemic disease as determined by the treating physician. Examples include, but are not limited to uncontrolled ventricular arrhythmia, uncontrolled major seizure disorder, unstable spinal cord compression, or superior vena cava syndrome.

Has a history or evidence of cardiac abnormalities within the 6 months prior to enrollment, including:

Serious, uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities including second-degree (Type II) or third-degree atrioventricular (AV) block.
Cardiomyopathy, myocarditis, myocardial infarction, acute coronary syndromes (including angina pectoris), coronary angioplasty, stenting, or bypass grafting.
Congestive heart failure [New York Heart Association (NYHA) Class III or IV]
Symptomatic pericarditis
Known history of Human Immunodeficiency Virus (HIV) infection
Active tuberculosis infection or other microbial infection or any active systemic infection requiring parenteral antibiotic therapy. All prior infections must have resolved following optimal therapy.
Participant has an active autoimmune disease that has required systemic treatment in the past 2 years (. i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
History of idiopathic pulmonary fibrosis, interstitial lung disease, bronchial asthma, organizing pneumonia, bronchiolitis obliterans, drug-induced pneumonitis, or idiopathic pneumonitis
History of organ transplantation including allogeneic bone marrow transplantation
Participant has a diagnosis of immunodeficiency or has been receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to initiating protocol therapy.
Participant has received a live vaccine within 7 days of initiating protocol therapy.
Psychiatric illness/social situations that would limit compliance with study requirements
Pregnant, lactating, breastfeeding, or intending to become pregnant during the study and for 150 days after the study

NCT ID

NCT06322693

添加审判日期

2024-03-21

更新日期

2024-03-21