RECRUITING

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

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Conditions

NeoplasmsAdvanced solid tumorsMetastatic solid tumorAnticancer agentsDostarlimabRemzistotugGSK4428859ABelrestotugNelistotugGSK5764227Head 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 ovarianfallopian tubeand primary peritoneal cancers

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a first time in-human (FTIH) study designed to investigate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of remzistotug in participants with select loco-regionally recurrent solid tumors or metastatic solid tumors where curative or standard treatment options have been exhausted.

Official Title

A Phase 1 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

Quick Facts

Study Start:2022-03-22
Study Completion:2027-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05277051

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:
  2. * Is not a woman of childbearing potential (WOCBP) or
  3. * 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.
  4. * A WOCBP must have a negative highly sensitive pregnancy test within 24-48 hours before the first dose of study intervention.
  5. * Requirement for Arm I only: Male participants agree to use contraception and for their female partner to use contraception, if applicable.
  6. * Histological or cytological documentation of loco-regionally recurrent solid tumors where curative treatment options have been exhausted, or metastatic solid tumors; types as follows:
  7. * head and neck squamous cell carcinoma (HNSCC)
  8. * non-small-cell lung cancer (NSCLC)
  9. * breast cancer (BC)
  10. * clear cell renal cell cancer (ccRCC)
  11. * gastric cancer (GC)
  12. * colorectal cancer (CRC)
  13. * endometrial cancer (EC)
  14. * 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.
  15. * Measurable disease per RECIST 1.1.
  16. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
  17. * Life expectancy of at least 12 weeks.
  18. * Adequate organ function, as defined in the protocol.
  19. * 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.
  1. * Prior treatment with the following therapies (specified time periods are from last dose of prior treatment to first dose of study intervention):
  2. * 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.
  3. * For Arm I only, prior treatment with orlotamab, enoblituzumab, I-Dxd, or other B7-H3 targeted agents.
  4. * Other prior immunotherapy, chemotherapy, targeted therapy, biological therapy or radiation therapy within specified periods as defined in the protocol.
  5. * 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).
  6. * Prior allogenic or autologous bone marrow transplantation or other solid organ transplantation.
  7. * Toxicity from previous anticancer treatment, including:
  8. * Greater than or equal to Grade 3 immune-mediated toxicity considered related to prior immunotherapy and that led to treatment discontinuation; or
  9. * History of myocarditis of any grade during a previous treatment with immunotherapy
  10. * 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.
  11. * Participant has a known additional malignancy that progressed or required active treatment within the last 2 years.

Contacts and Locations

Study Contact

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

Principal Investigator

GSK Clinical Trials
STUDY_DIRECTOR
GlaxoSmithKline

Study Locations (Sites)

GSK Investigational Site
San Francisco, California, 94158
United States
GSK Investigational Site
Charlotte, North Carolina, 28204
United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73104
United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19111
United States
GSK Investigational Site
Dallas, Texas, 75230
United States
GSK Investigational Site
San Antonio, Texas, 78229
United States
GSK Investigational Site
Salt Lake City, Utah, 84112
United States

Collaborators and Investigators

Sponsor: GlaxoSmithKline

  • GSK Clinical Trials, STUDY_DIRECTOR, GlaxoSmithKline

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-22
Study Completion Date2027-08-31

Study Record Updates

Study Start Date2022-03-22
Study Completion Date2027-08-31

Terms related to this study

Keywords Provided by Researchers

  • Advanced solid tumors
  • Metastatic solid tumor
  • Anticancer agents
  • Dostarlimab
  • Remzistotug
  • GSK4428859A
  • Belrestotug
  • Nelistotug
  • GSK5764227
  • 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

Additional Relevant MeSH Terms

  • Neoplasms