Study of the Safety and Effectiveness of GSK6097608 in Participants With Advanced Solid Tumors (NCT04446351)
A Phase 1 First-Time-in-Human, Open-Label Study of GSK6097608 Administered as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors
🩺 Plain-English Summary (8th-Grade Level)
This first-time-in-human (FTIH) study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of escalating doses of GSK6097608 given as monotherapy and in combination with dostarlimab in participants with advanced solid tumors. In addition, dostarlimab will be given as monotherapy (Arm D); and in combination with belrestotug (Arm E); and with GSK6097608 + belrestotug (Arm F) in Japanese and Chinese participants. The study may assess the PK/PD cohorts for Arm E and/or Arm F in participants outside of China and Japan. Additionally, dostarlimab will be given in combination with cobolimab in Japanese participants. Drug name mentioned as belrestotug, GSK4428859A and EOS884448 are interchangeable for the same compound. In the rest of the document, the drug will be referred to as belrestotug.
Who can join: Review the eligibility criteria below.
Location: GSK Investigational Site — Los Angeles, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (11 Sites)
- GSK Investigational Site — Los Angeles, California
- GSK Investigational Site — Boston, Massachusetts
- GSK Investigational Site — Dallas, Texas
- GSK Investigational Site — Houston, Texas
- GSK Investigational Site — San Antonio, Texas
- GSK Investigational Site — Ottawa, Ontario
- GSK Investigational Site — Toronto, Ontario
- GSK Investigational Site — Chiba,
- GSK Investigational Site — Tokyo,
- GSK Investigational Site — Seoul,
- GSK Investigational Site — Seoul,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Neoplasms
- A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Participants With Advanced Cancers — St Louis, Missouri
- A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER) — Goodyear, Arizona
- Study of TSR-042, an Anti-programmed Cell Death-1 Receptor (PD-1) Monoclonal Antibody, in Participants With Advanced Solid Tumors — Birmingham, Alabama
- Hispanic Adapted and Culturally Relevant Exercising Together — Tucson, Arizona
- M7824 Related Adverse Effects in Adults With Cancer — Bethesda, Maryland
- Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered T Cells in NY-ESO-1 and/or LAGE-1a Positive Solid Tumors — Duarte, California
Explore by condition: All Neoplasms clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.