A Phase I First-Time-in-Human, Open-Label Study of GSK4381562 Administered as Monotherapy and in Combination With Anticancer Agents in Participants With Selected Advanced Solid Tumors

Study Identifier:
GSK 217228
CT.gov Identifier:
NCT05277051
EudraCT Identifier:
202100496895
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruitment Complete

Considering participating in a START clinical trial?

Get Started

Study Summary

To evaluate SRF813 in Patients with Cancer

To investigate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of GSK4381562 in participants with select loco-regionally recurrent solid tumors or metastatic solid tumors where curative or standard treatment options have been exhausted

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Unspecified Cancer
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Female & Male
Age
18+ years
Study Drug
Drug: Experimental: Participants receiving GSK4381562 monotherapy (Arm A)
Read More
Drug: Experimental: Participants receiving GSK4381562 plus dostarlimab (Arm B)
Drug: Drug: Dostarlimab
Drug: Experimental: Participants receiving GSK4381562 plus dostarlimab plus belrestotug (Arm C)
Drug: Drug: Belrestotug
Drug: Experimental: Participants receiving dostarlimab plus belrestotug (Arm D)
Drug: Experimental: Participants receiving dostarlimab plus belrestotug plus GSK4381562 (Arm E)
Drug: Experimental: Participants receiving dostarlimab plus belrestotug plus nelistotug (Arm F)
Drug: Drug: Nelistotug
Drug: Experimental: China Cohort: Participants receiving dostarlimab (Arm G)
Drug: Experimental: China Cohort: Participants receiving dostarlimab plus belrestotug (Arm H)
Drug: Experimental: Participants receiving GSK5764227 plus dostarlimab (Arm I)
Drug: Drug: GSK5764227
Study Status
Indicates the current recruitment status or the expanded access status
Recruitment Complete

Requirements information
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
  • 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.

Clinical Study Information for Healthcare Providers

By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.

View Study Information

Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Madrid, Spain (CIOCC)
Madrid, Spain, 28050
Investigator
Maria de Miguel
Status
Terminated/Withdrawn
Condition(s) Treated at Site
Unspecified Cancer