对晚期实体瘤患者进行的 GSK4381562 首次人体研究

计划状态

招聘

阶段

第 1 阶段

允许先接受免疫治疗

CRC 指导的试验

药物

Dostarlimab, GSK4381562

标签

MSI-H/ MMRd、MSS/ MMRp

评论

GSK4381562 plus dostarlimab plus GSK4428859A

GSK4381562: A human immunoglobulin G1 (IgG1) monoclonal antibody directed against poliovirus receptor-related immunoglobulin (PVRIG; PVR Related Immunoglobulin Domain Containing Protein; CD112R), with potential immune checkpoint inhibitory and antineoplastic activities

Dostarlimab (Jemperli®): anti PD-1 (similar to pembrolizumab and nivolumab)
GSK4428859A: anti-TIGIT IgG1 monoclonal antibody (mAb)

有用链接

地点 位置状态
美国
GSK Investigational Site
加利福尼亚州旧金山 94158
招聘
GSK Investigational Site
Charlotte, North Carolina 28204
招聘
GSK Investigational Site
俄克拉荷马州俄克拉荷马城 73104
招聘
GSK Investigational Site
Philadelphia, Pennsylvania 19111
招聘
GSK Investigational Site
德克萨斯州达拉斯 75230
招聘
GSK Investigational Site
德克萨斯州圣安东尼奥 78229
招聘
GSK Investigational Site
犹他州盐湖城 84112
招聘
澳大利亚
GSK Investigational Site
西澳大利亚奈德兰兹 6009
招聘
加拿大
GSK Investigational Site
安大略省渥太华 K1H 8L6
招聘
GSK Investigational Site
安大略省多伦多 M5G 2M9
招聘
中国
GSK Investigational Site
Jinan 250117
招聘
GSK Investigational Site
Shanghai 200126
招聘
法国
GSK Investigational Site
Dijon Cedex 21000
招聘
GSK Investigational Site
Lille 59000
招聘
日本
GSK Investigational Site
千叶 277-8577
招聘
GSK Investigational Site
东京 104-0045
招聘
大韩民国
GSK Investigational Site
首尔 03080
招聘
GSK Investigational Site
首尔 03722
招聘
西班牙
GSK Investigational Site
巴塞罗那 08035
招聘
GSK Investigational Site
马德里 28040
招聘
GSK Investigational Site
马德里 28050
招聘
GSK Investigational Site
MAlaga 29010
招聘
英国
GSK Investigational Site
曼彻斯特 M20 4BX
招聘
GSK Investigational Site
萨顿 SM2 5PT
招聘

联系方式

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

纳入标准

Inclusion criteria:

* A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:

* Is not a woman of childbearing potential (WOCBP) or
* Is a WOCBP and using a contraceptive method that is highly effective with a failure rate of less than (<)1 percent ([%] per year), during the intervention period and for specified time after end of study treatment.
* A WOCBP must have a negative highly sensitive pregnancy test within 24-48 hours before the first dose of study intervention.
* Requirement for Arm I only: Male participants agree to use contraception and for their female partner to use contraception, if applicable.
* Histological or cytological documentation of loco-regionally recurrent solid tumors where curative treatment options have been exhausted, or metastatic solid tumors; types as follows:

* head and neck squamous cell carcinoma (HNSCC)
* non-small-cell lung cancer (NSCLC)
* breast cancer (BC)
* clear cell renal cell cancer (ccRCC)
* gastric cancer (GC)
* colorectal cancer (CRC)
* endometrial cancer (EC)
* epithelial ovarian, fallopian tube, and primary peritoneal cancers- Disease that has progressed after standard therapy for the specific tumor type, or for which standard therapy has proven to be ineffective, intolerable, or is considered inappropriate, or if no further standard therapy exists.
* 根据 RECIST 1.1,可测量的疾病。
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
* Life expectancy of at least 12 weeks.
* Adequate organ function, as defined in the protocol.
* For participants enrolled in a PK/PD cohort, participant agrees to a fresh tumor biopsy during Screening and at approximately 6-weeks after treatment initiation.

排除标准

排除标准:

* Prior treatment with the following therapies (specified time periods are from last dose of prior treatment to first dose of study intervention):

* Any therapy directed against Polio virus receptor (PVR)-related immunoglobulin domain-containing (PVRIG) (COM701 or other anti-PVRIG monoclonal antibody [mAb]) or other cluster of differentiation (CD)226 axis receptor (T-cell immunoglobulin and immunoreceptor tyrosine-based inhibition motif domain [TIGIT] or CD96) at any time.
* For Arm I only, prior treatment with orlotamab, enoblituzumab, I-Dxd, or other B7-H3 targeted agents.
* Other prior immunotherapy, chemotherapy, targeted therapy, biological therapy or radiation therapy within specified periods as defined in the protocol.
* Investigational therapy: if the participant has participated in a clinical study and has received an investigational product within 4 weeks or 5 half-lives of the investigational product (whichever is shorter).
* Prior allogenic or autologous bone marrow transplantation or other solid organ transplantation.
* Toxicity from previous anticancer treatment, including:

* Greater than or equal to Grade 3 immune-mediated toxicity considered related to prior immunotherapy and that led to treatment discontinuation; or
* History of myocarditis of any grade during a previous treatment with immunotherapy
* Toxicity related to prior treatment that has not resolved to less than or equal to (<=) Grade 1. Non clinically relevant Grade 2 toxicities, not constituting a safety risk by investigator judgment are allowed.
* Participant has a known additional malignancy that progressed or required active treatment within the last 2 years.

NCT ID

NCT05277051

添加审判日期

2022-03-14

更新日期

2024-11-12