NeoplasmsPhase 1PanTumor-101NCT06551142
A Study of GSK5764227 in Participants With Advanced Solid Tumors (EMBOLD)
A Phase 1 study testing Ris-Rez, Cisplatin and Carboplatin in people with Neoplasms, run by GlaxoSmithKline at 67 sites in 13 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Ris-Rez, Cisplatin and Carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 845 participants
- Where
- 67 sitesin 13 countries
- Study dates
- 30 Sep 2024to 8 Jun 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants at least 18 years of age (≥18 years)
- Participants with histologically confirmed advanced/metastatic solid tumors, as defined per study phase and cohort, as follows:
- Phase 1a:
- Participants with advanced/metastatic solid tumors.
- For monotherapy dose escalation: participants must have progressed on or become intolerant to all available SOC therapies.
- For combination dose escalation: participants must have received 3 or fewer prior lines of systemic anticancer therapy in the advanced/metastatic setting
Show all 10Show fewer
- Has at least 1 target lesion per RECIST 1.1, as determined by the investigator.
- Has an ECOG performance status of 0 or 1, with no deterioration in the 2 weeks before first dose.
- Has adequate organ function.
- Where available, participants should provide a formalin fixed and paraffin embedded (FFPE) tumor sample from the most recent biopsy of primary cancer or from a metastatic site for central testing.
Who cannot join
- Has ongoing adverse reaction(s) from prior therapy that has(have) not recovered to ≤Grade 1 or to the baseline status preceding prior therapy.
- Prior treatment with orlotamab, enoblituzumab, I-Dxd, or other B7-H3 targeted agents.
- Primary brain tumor or evidence of brain metastasis (unless meeting the following criteria at the same time: asymptomatic; medically stable for at least 4 weeks prior to initial dosing; no steroid treatment required for at least 4 weeks prior to initial dosing; and no midline shift due to herniation); or untreated progression due to brain metastasis or primary brain tumor during or after the last treatment prior to screening; or evidence of meningeal/brainstem involvement; or evidence of spinal cord compression (detected by radiographic examination, symptomatic or not).
- Any of the following cardiac examination abnormality:
- Has QT interval, corrected for heart rate (QTc) >450 msec or QTc >480 msec for participants with bundle branch block.
- Evidence of current clinically significant arrhythmias or ECG abnormalities (e.g., complete left bundle branch block, third-degree atrioventricular [AV] block, second-degree AV block, PR interval >250 msec).
Show all 13Show fewer
- Risk factors of prolonged QTc or arrhythmia events, such as heart failure, refractory hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death of any direct relative under 40 years old or any concomitant medications that prolong the QT interval.
- Left ventricular ejection fraction (LVEF) <50%.
- Has severe, uncontrolled or active CV disorders, serious or poorly controlled hypertension, clinically significant bleeding symptoms or serious arteriovenous thromboembolic events
- Participants with evidence of current ILD/non-infectious pneumonitis OR a prior history of ILD/non-infectious pneumonitis requiring high-dose glucocorticoids OR suspected ILD/non-infectious pneumonitis that cannot be ruled out by imaging.
- Has a history of autoimmune disease that has required systemic treatments in the 2 years prior to screening. Participants with prior history of autoimmune disease must be discussed with the medical monitor. Replacement therapy is not considered a form of systemic therapy (e.g., thyroid hormone for autoimmune thyroiditis or insulin is not exclusionary).
- Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant.
- Has received prior anticancer therapy within 28 days of the first dose of study intervention or having to continue these medications during the study.
Trial locations and contacts
67 sites in 13 countries. Contact the study team or a site near you to ask about taking part.
67 sites in 13 countries
United States15 sites, 15 recruiting
- Recruiting
GSK Investigational Site
Austin, Texas, 78705
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Boston, Massachusetts, 02114
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Dallas, Texas, 75230
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Denver, Colorado, 80218
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Detroit, Michigan, 48201
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Fort Wayne, Indiana, 46804
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Myrtle Beach, South Carolina, 29572
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Nashville, Tennessee, 37203
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
New Brunswick, New Jersey, 08903
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
New Haven, Connecticut, 06511
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Norfolk, Virginia, 23502
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
San Antonio, Texas, 78229
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Stanford, California, 94063
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Tyler, Texas, 75702
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
West Valley City, Utah, 84119
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Spain9 sites, 9 recruiting
- Recruiting
GSK Investigational Site
Badajoz, 06080
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Barcelona, 08035
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Barcelona, 08036
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Madrid, 28034
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Madrid, 28040
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Madrid, 28041
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Málaga, 29010
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Valencia, 46026
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Zaragoza, 50009
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Taiwan6 sites, 6 recruiting
- Recruiting
GSK Investigational Site
Changhua, 500
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Kaohsiung City, 83301
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Taichung, 40447
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Tainan, 704
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Taipei, 10002
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Taipei, 11217
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
United Kingdom6 sites, 6 recruiting
- Recruiting
GSK Investigational Site
Edinburgh, EH4 2XU
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Glasgow, G12 0YN
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
London, W1G 6AD
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
London, WC1E 6AG
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Manchester, M20 4BX
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Newcastle upon Tyne, NE7 7DN
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Canada5 sites, 5 recruiting
- Recruiting
GSK Investigational Site
Hamilton, Ontario, L8V 5C2
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Montreal, Quebec, H4A 3J1
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Ottawa, Ontario, K1H 8L6
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Sherbrooke, Quebec, J1H 5N4
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Toronto, Ontario, M5G 1X6
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Japan5 sites, 5 recruiting
- Recruiting
GSK Investigational Site
Aichi, 464-8681
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Chiba, 277-8577
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Shizuoka, 411-8777
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Tokyo, 104-0045
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Tokyo, 135-8550
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Israel4 sites, 4 recruiting
- Recruiting
GSK Investigational Site
Jerusalem, 91031
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Jerusalem, 9112001
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Ramat Gan, 5266202
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Tel Aviv, 64239
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Italy4 sites, 4 recruiting
- Recruiting
GSK Investigational Site
Milan, 20141
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Naples, 80131
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Roma, 00168
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Verona, 37134
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
South Korea4 sites, 4 recruiting
- Recruiting
GSK Investigational Site
Gyeonggi-do, 10408
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Seoul, 03080
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Seoul, 03722
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Seoul, 135-710
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
France3 sites, 3 recruiting
- Recruiting
GSK Investigational Site
Bordeaux, 33076
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Lyon, 69373
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Villejuif, 94805
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Argentina2 sites, 1 recruiting
- Completed
GSK Investigational Site
Rosario, S2002
- Recruiting
GSK Investigational Site
Viedma, R8500ACE
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Hong Kong2 sites, 2 recruiting
- Recruiting
GSK Investigational Site
Pokfulam
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Shatin
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Panama2 sites, 2 recruiting
- Recruiting
GSK Investigational Site
Panama City
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Panama City
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
About this study
Official title: A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of GSK5764227 as Monotherapy and in Combination in Participants With Advanced Solid Tumors
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
- Conditions
- Neoplasms
- Being tested
- Ris-Rez, Cisplatin, Carboplatin, Atezolizumab, Pembrolizumab
- Keywords
- Solid Tumors, GSK5764227, Neoplasms, EMBOLD PanTumor-101, Risvutatug rezetecan, Ris-Rez
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ris-RezBiological
Ris-Rez will be administered
CisplatinDrug
Cisplatin will be administered
CarboplatinDrug
Carboplatin will be administered
AtezolizumabBiological
Atezolizumab will be administered
PembrolizumabBiological
Pembrolizumab will be administered
DurvalumabBiological
Durvalumab will be administered
CetuximabBiological
Cetuximab will be administered
BevacizumabBiological
Bevacizumab will be administered
TarlatamabBiological
Tarlatamab will be administered
DostarlimabBiological
Dostarlimab will be administered
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a- Dose escalation- Monotherapy | Experimental | Not described Receives: Biological: Ris-Rez |
| Phase 1a- Dose escalation- Combination therapy | Experimental | Not described Receives: Biological: Ris-Rez; Drug: Cisplatin; Drug: Carboplatin; Biological: Atezolizumab; Biological: Pembrolizumab; Biological: Durvalumab; Biological: Cetuximab; Biological: Bevacizumab; Biological: Tarlatamab; Biological: Dostarlimab |
| Phase 1b- Dose optimisation- Monotherapy | Experimental | Not described Receives: Biological: Ris-Rez |
| Phase 1b- Dose optimisation- Combination therapy | Experimental | Not described Receives: Biological: Ris-Rez; Biological: Atezolizumab; Biological: Dostarlimab |
| Phase 1b- Dose expansion- Monotherapy | Experimental | Not described Receives: Biological: Ris-Rez |
| Phase 1b- Dose expansion- Combination therapy | Experimental | Not described Receives: Biological: Ris-Rez; Biological: Tarlatamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1a: Number of participants with Adverse Events (AEs)
Measured: Up to approximately 28 months
Phase 1a: Number of participants with Dose Limiting Toxicities (DLTs)
Measured: Up to 21 days
Phase 1a: Number of participants with AEs, serious adverse events (SAEs) and adverse events of special interest (AESIs) by severity
Measured: Up to approximately 30 months
Phase 1a: Number of participants with AEs leading to dose modifications
Measured: 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
Measured: Up to approximately 28 months
Phase 1b: Confirmed Objective Response Rate (cORR)
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.
Measured: Up to approximately 27 months
Secondary outcomes (18)
Phase 1a and Phase 1b: Maximum concentration (Cmax) of Ris-Rez
Measured: Up to approximately 28 months
Phase 1a and Phase 1b: Time to reach maximum concentration (Tmax) of Ris-Rez
Measured: Up to approximately 28 months
Phase 1a and Phase 1b: Area under the curve (AUC) of Ris-Rez
Measured: Up to approximately 28 months
Phase 1a and Phase 1b: Trough concentration (Ctrough) of Ris-Rez (conjugated antibody)
Measured: Up to approximately 28 months
Phase 1a and Phase 1b: Trough concentration (Ctrough) of Ris-Rez (total antibody)
Measured: Up to approximately 28 months
Phase 1a and Phase 1b: Trough concentration (Ctrough) of GSK5757810 (small-molecule toxin)
Measured: Up to approximately 28 months
Phase 1a: Confirmed Objective Response Rate (cORR)
cORR is defined as the proportion of participants who have confirmed CR or PR, per RECIST V1.1 by investigator
Measured: Up to approximately 33 months
Phase 1a: Disease control rate at 12 weeks (DCR12)
DCR is defined as the proportion of participants who have achieved CR, PR or Stable disease (SD) ≥11 weeks per RECIST v1.1 by investigator assessment
Measured: At 12 weeks
Phase 1b: Disease control rate at 12 weeks (DCR12)
DCR defined as the proportion of participants who have achieved CR, PR or SD ≥11 weeks per RECIST 1.1 or other imaging criteria for defined tumor types by investigator.
Measured: At 12 weeks
Phase 1a: Duration of Response (DoR)
DoR is defined as the date of first documented objective response (CR/PR) until per RECIST 1.1 by investigator assessment to the date of first documented PD or death due to any cause, whichever comes first.
Measured: Up to approximately 33 months
Phase 1b: Duration of Response (DoR)
DoR defined as the time from the date of first documented objective response (CR/PR) per RECIST 1.1 or other imaging criteria for defined tumor types by investigator assessment to the date of first documented PD or death due to any cause, whichever comes first.
Measured: Up to approximately 33 months
Phase 1b: Proportion of Participants with Tumour antigen Decrease From Baseline >=50% response rate
Tumour antigen response rate is defined as a proportion of participants with ≥50% decrease from baseline in the tumour antigen during the study. Any observed ≥50% decrease will be confirmed by repeat assessment after approximately 3 weeks
Measured: Up to approximately 33 months
Phase 1a and Phase 1b: Number of participants with Antidrug antibody (ADA) or Neutralizing Antibody (NAb)
Measured: Up to approximately 30 months
Phase 1a and Phase 1b: Titers of ADA against Ris-Rez
Measured: Up to approximately 30 months
Phase 1b: Number of participants with AEs, SAEs and AESI by severity
Measured: Up to approximately 30 months
Phase 1b: Number of participants with AEs leading to dose modifications
Measured: Up to approximately 27 months
Phase 1b: Number of participants with changes in vital signs, body weight, laboratory tests, ECG, ECHO and ECOG performance status
Measured: Up to approximately 28 months
Phase 1b: Progression-Free Survival (PFS)
PFS is defined as the time from randomization (dose optimization), or time from first dose where there is no randomization (dose expansion) until the earliest date of documented disease progression (investigator-assessed according to RECIST 1.1 or other imaging criteria for defined tumor types) or death due to any cause.
Measured: Up to approximately 33 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start30 Sep 2024
- Primary completion16 Oct 2028 (estimated)
- Study completion8 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 845 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06551142
- Sponsor's protocol ID
- 223054
- Other IDs
- 2024-513663-10
- Acronym
- PanTumor-101
- Status last verified
- May 2026
- First submitted
- 9 Aug 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of GSK5764227 as Monotherapy and in Combination in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06551142
- Acronym / sponsor ID
- PanTumor-101 / 223054
- Conditions
- Neoplasms
- Keywords
- Solid Tumors, GSK5764227, Neoplasms, EMBOLD PanTumor-101, Risvutatug rezetecan, Ris-Rez
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 845 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 16 Oct 2028 (estimated)
- Study completion
- 8 Jun 2029 (estimated)
- First posted
- 13 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Phase 1a- Dose escalation- Monotherapy | Experimental | Biological: Ris-Rez |
| Phase 1a- Dose escalation- Combination therapy | Experimental | Biological: Ris-Rez, Drug: Cisplatin, Drug: Carboplatin, Biological: Atezolizumab, Biological: Pembrolizumab, Biological: Durvalumab, Biological: Cetuximab, Biological: Bevacizumab, Biological: Tarlatamab, Biological: Dostarlimab |
| Phase 1b- Dose optimisation- Monotherapy | Experimental | Biological: Ris-Rez |
| Phase 1b- Dose optimisation- Combination therapy | Experimental | Biological: Ris-Rez, Biological: Atezolizumab, Biological: Dostarlimab |
| Phase 1b- Dose expansion- Monotherapy | Experimental | Biological: Ris-Rez |
| Phase 1b- Dose expansion- Combination therapy | Experimental | Biological: Ris-Rez, Biological: Tarlatamab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female participants at least 18 years of age (≥18 years)
- Participants with histologically confirmed advanced/metastatic solid tumors, as defined per study phase and cohort, as follows:
- Participants with advanced/metastatic solid tumors.
- For monotherapy dose escalation: participants must have progressed on or become intolerant to all available SOC therapies.
- For combination dose escalation: participants must have received 3 or fewer prior lines of systemic anticancer therapy in the advanced/metastatic setting
Key exclusion criteria (13 listed)
- Has ongoing adverse reaction(s) from prior therapy that has(have) not recovered to ≤Grade 1 or to the baseline status preceding prior therapy.
- Prior treatment with orlotamab, enoblituzumab, I-Dxd, or other B7-H3 targeted agents.
- Primary brain tumor or evidence of brain metastasis (unless meeting the following criteria at the same time: asymptomatic; medically stable for at least 4 weeks prior to initial dosing; no steroid treatment required for at least 4 weeks prior to initial dosing; and no midline shift due to herniation); or untreated progression due to brain metastasis or primary brain tumor during or after the last treatment prior to screening; or evidence of meningeal/brainstem involvement; or evidence of spinal cord compression (detected by radiographic examination, symptomatic or not).
- Any of the following cardiac examination abnormality:
- Has severe, uncontrolled or active CV disorders, serious or poorly controlled hypertension, clinically significant bleeding symptoms or serious arteriovenous thromboembolic events
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ris-RezRis-Rez will be administered | Biological | Phase 1a- Dose escalation- Combination therapy, Phase 1a- Dose escalation- Monotherapy, Phase 1b- Dose expansion- Combination therapy, Phase 1b- Dose expansion- Monotherapy, Phase 1b- Dose optimisation- Combination therapy, Phase 1b- Dose optimisation- Monotherapy |
| CisplatinCisplatin will be administered | Drug | Phase 1a- Dose escalation- Combination therapy |
| CarboplatinCarboplatin will be administered | Drug | Phase 1a- Dose escalation- Combination therapy |
| AtezolizumabAtezolizumab will be administered | Biological | Phase 1a- Dose escalation- Combination therapy, Phase 1b- Dose optimisation- Combination therapy |
| PembrolizumabPembrolizumab will be administered | Biological | Phase 1a- Dose escalation- Combination therapy |
| DurvalumabDurvalumab will be administered | Biological | Phase 1a- Dose escalation- Combination therapy |
| CetuximabCetuximab will be administered | Biological | Phase 1a- Dose escalation- Combination therapy |
| BevacizumabBevacizumab will be administered | Biological | Phase 1a- Dose escalation- Combination therapy |
| TarlatamabTarlatamab will be administered | Biological | Phase 1a- Dose escalation- Combination therapy, Phase 1b- Dose expansion- Combination therapy |
| DostarlimabDostarlimab will be administered | Biological | Phase 1a- Dose escalation- Combination therapy, Phase 1b- Dose optimisation- Combination therapy |
Primary outcome
Phase 1a: Number of participants with Adverse Events (AEs)
Time frame: Up to approximately 28 months
Phase 1a: Number of participants with Dose Limiting Toxicities (DLTs)
Time frame: Up to 21 days
Phase 1a: Number of participants with AEs, serious adverse events (SAEs) and adverse events of special interest (AESIs) by severity
Time frame: Up to approximately 30 months
Phase 1a: Number of participants with AEs leading to dose modifications
Time frame: 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
Time frame: Up to approximately 28 months
Phase 1b: Confirmed Objective Response Rate (cORR)
Time frame: 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.
18 secondary outcomes
Phase 1a and Phase 1b: Maximum concentration (Cmax) of Ris-Rez
Time frame: Up to approximately 28 months
Phase 1a and Phase 1b: Time to reach maximum concentration (Tmax) of Ris-Rez
Time frame: Up to approximately 28 months
Phase 1a and Phase 1b: Area under the curve (AUC) of Ris-Rez
Time frame: Up to approximately 28 months
Phase 1a and Phase 1b: Trough concentration (Ctrough) of Ris-Rez (conjugated antibody)
Time frame: Up to approximately 28 months
Phase 1a and Phase 1b: Trough concentration (Ctrough) of Ris-Rez (total antibody)
Time frame: Up to approximately 28 months
Phase 1a and Phase 1b: Trough concentration (Ctrough) of GSK5757810 (small-molecule toxin)
Time frame: Up to approximately 28 months
Phase 1a: Confirmed Objective Response Rate (cORR)
Time frame: Up to approximately 33 months
Phase 1a: Disease control rate at 12 weeks (DCR12)
Time frame: At 12 weeks
Phase 1b: Disease control rate at 12 weeks (DCR12)
Time frame: At 12 weeks
Phase 1a: Duration of Response (DoR)
Time frame: Up to approximately 33 months
Phase 1b: Duration of Response (DoR)
Time frame: Up to approximately 33 months
Phase 1b: Proportion of Participants with Tumour antigen Decrease From Baseline >=50% response rate
Time frame: Up to approximately 33 months
Phase 1a and Phase 1b: Number of participants with Antidrug antibody (ADA) or Neutralizing Antibody (NAb)
Time frame: Up to approximately 30 months
Phase 1a and Phase 1b: Titers of ADA against Ris-Rez
Time frame: Up to approximately 30 months
Phase 1b: Number of participants with AEs, SAEs and AESI by severity
Time frame: Up to approximately 30 months
Phase 1b: Number of participants with AEs leading to dose modifications
Time frame: Up to approximately 27 months
Phase 1b: Number of participants with changes in vital signs, body weight, laboratory tests, ECG, ECHO and ECOG performance status
Time frame: Up to approximately 28 months
Phase 1b: Progression-Free Survival (PFS)
Time frame: Up to approximately 33 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
Related trials for Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
67 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ris-Rez, Cisplatin and Carboplatin in people with Neoplasms, run by GlaxoSmithKline at 67 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 sites in United States, Spain, Taiwan, United Kingdom, Canada and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1a: Number of participants with Adverse Events (AEs) (time frame: Up to approximately 28 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.