First-Time-in-Human Study of GSK4381562 in Participants With Advanced Solid Tumors

Program Status

Recruiting

Phase

Phase 1

Prior Immunotherapy Allowed

Yes

CRC-directed Trial

Yes

Drugs

Dostarlimab, GSK4381562

Tags

MSI-H/ MMRd, MSS/ MMRp

Comments

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)

Helpful Links

Location Location Status
United States
GSK Investigational Site
San Francisco, California 94158
Recruiting
GSK Investigational Site
Charlotte, North Carolina 28204
Recruiting
GSK Investigational Site
Oklahoma City, Oklahoma 73104
Recruiting
GSK Investigational Site
Philadelphia, Pennsylvania 19111
Recruiting
GSK Investigational Site
Dallas, Texas 75230
Recruiting
GSK Investigational Site
San Antonio, Texas 78229
Recruiting
GSK Investigational Site
Salt Lake City, Utah 84112
Recruiting
Australia
GSK Investigational Site
Nedlands, Western Australia 6009
Recruiting
Canada
GSK Investigational Site
Ottawa, Ontario K1H 8L6
Recruiting
GSK Investigational Site
Toronto, Ontario M5G 2M9
Recruiting
China
GSK Investigational Site
Jinan 250117
Recruiting
GSK Investigational Site
Shanghai 200126
Recruiting
France
GSK Investigational Site
Dijon Cedex 21000
Recruiting
GSK Investigational Site
Lille 59000
Recruiting
Japan
GSK Investigational Site
Chiba 277-8577
Recruiting
GSK Investigational Site
Tokyo 104-0045
Recruiting
Korea, Republic of
GSK Investigational Site
Seoul 03080
Recruiting
GSK Investigational Site
Seoul 03722
Recruiting
Spain
GSK Investigational Site
Barcelona 08035
Recruiting
GSK Investigational Site
Madrid 28040
Recruiting
GSK Investigational Site
Madrid 28050
Recruiting
GSK Investigational Site
MAlaga 29010
Recruiting
United Kingdom
GSK Investigational Site
Manchester M20 4BX
Recruiting
GSK Investigational Site
Sutton SM2 5PT
Recruiting

Contacts

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

Inclusion Criteria

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.
* Measurable disease per RECIST 1.1.
* 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.

Exclusion Criteria

Exclusion Criteria:

* 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

Date Trial Added

2022-03-14

Updated Date

2024-11-12