计划状态
招聘阶段
第 1 阶段允许先接受免疫治疗
是CRC 指导的试验
是药物
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)
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
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.