A Study of GSK5764227 in Participants With Advanced Solid Tumors (EMBOLD)
Condition(s) studied
Investigational drug(s) / intervention(s)
Ris-Rez: Ris-Rez will be administered
Cisplatin: Cisplatin will be administered
Carboplatin: Carboplatin will be administered
Atezolizumab: Atezolizumab will be administered
Pembrolizumab: Pembrolizumab will be administered
Durvalumab: Durvalumab will be administered
Cetuximab: Cetuximab will be administered
Bevacizumab: Bevacizumab will be administered
Tarlatamab: Tarlatamab will be administered
Dostarlimab: Dostarlimab will be administered
Study summary
The goal of this study is to assess the safety, tolerability, clinical activity and pharmacokinetics of Risvutatug rezetecan (Ris-Rez), also known as GSK5764227. The study will also see how the levels of Ris-Rez will change over time at different dose amounts when administered alone and in combination with other medicines like carboplatin, cisplatin, atezolizumab, pembrolizumab, durvalumab, bevacizumab, cetuximab, tarlatamab, dostarlimab
Eligibility
Primary outcome measure(s)
- Phase 1a: Number of participants with Adverse Events (AEs) — Up to approximately 28 months
- Phase 1a: Number of participants with Dose Limiting Toxicities (DLTs) — Up to 21 days
- Phase 1a: Number of participants with AEs, serious adverse events (SAEs) and adverse events of special interest (AESIs) by severity — Up to approximately 30 months
- Phase 1a: Number of participants with AEs leading to dose modifications — Up to approximately 28 months
- Phase 1a: Number of participants with changes in vital signs, body weight, laboratory tests, electrocardiogram (ECG) and Eastern Cooperative Oncology Group (ECOG) performance status — Up to approximately 28 months
- Phase 1b: Confirmed Objective Response Rate (cORR) — Up to approximately 27 months
cORR is defined as the proportion of participants who have confirmed Complete response (CR) or Partial response (PR), assessed by the investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST V1.1) criteria or other imaging criteria for defined tumor types.
Trial sites (67)
| Facility | City | Region | Status |
|---|---|---|---|
| GSK Investigational Site | Stanford | California | Recruiting |
| GSK Investigational Site | Denver | Colorado | Recruiting |
| GSK Investigational Site | New Haven | Connecticut | Recruiting |
| GSK Investigational Site | Fort Wayne | Indiana | Recruiting |
| GSK Investigational Site | Boston | Massachusetts | Recruiting |
| GSK Investigational Site | Detroit | Michigan | Recruiting |
| GSK Investigational Site | New Brunswick | New Jersey | Recruiting |
| GSK Investigational Site | Myrtle Beach | South Carolina | Recruiting |
| GSK Investigational Site | Nashville | Tennessee | Recruiting |
| GSK Investigational Site | Austin | Texas | Recruiting |
| GSK Investigational Site | Dallas | Texas | Recruiting |
| GSK Investigational Site | San Antonio | Texas | Recruiting |
| GSK Investigational Site | Tyler | Texas | Recruiting |
| GSK Investigational Site | West Valley City | Utah | Recruiting |
| GSK Investigational Site | Norfolk | Virginia | Recruiting |
| GSK Investigational Site | Rosario | Argentina | Completed |
| GSK Investigational Site | Viedma | Argentina | Recruiting |
| GSK Investigational Site | Hamilton | Ontario | Recruiting |
| GSK Investigational Site | Ottawa | Ontario | Recruiting |
| GSK Investigational Site | Toronto | Ontario | Recruiting |
| GSK Investigational Site | Montreal | Quebec | Recruiting |
| GSK Investigational Site | Sherbrooke | Quebec | Recruiting |
| GSK Investigational Site | Bordeaux | France | Recruiting |
| GSK Investigational Site | Lyon | France | Recruiting |
| GSK Investigational Site | Villejuif | France | Recruiting |
| GSK Investigational Site | Pokfulam | Hong Kong | Recruiting |
| GSK Investigational Site | Shatin | Hong Kong | Recruiting |
| GSK Investigational Site | Jerusalem | Israel | Recruiting |
| GSK Investigational Site | Jerusalem | Israel | Recruiting |
| GSK Investigational Site | Ramat Gan | Israel | Recruiting |
| GSK Investigational Site | Tel Aviv | Israel | Recruiting |
| GSK Investigational Site | Milan | Italy | Recruiting |
| GSK Investigational Site | Naples | Italy | Recruiting |
| GSK Investigational Site | Roma | Italy | Recruiting |
| GSK Investigational Site | Verona | Italy | Recruiting |
| GSK Investigational Site | Aichi | Japan | Recruiting |
| GSK Investigational Site | Chiba | Japan | Recruiting |
| GSK Investigational Site | Shizuoka | Japan | Recruiting |
| GSK Investigational Site | Tokyo | Japan | Recruiting |
| GSK Investigational Site | Tokyo | Japan | Recruiting |
+ 27 more sites — see the full list on the official registry below.
On this site
📄 Tecentriq (atezolizumab) drug profile → 📄 Keytruda (pembrolizumab) drug profile → 📄 Imfinzi (durvalumab) drug profile → 📄 Avastin (bevacizumab) drug profile →More GlaxoSmithKline trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06551142 on ClinicalTrials.gov ↗ ← All trials in Italy