A Phase 1 interventional study of Ris-Rez and Cisplatin in Neoplasms, sponsored by GlaxoSmithKline. Recruiting at 67 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment
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
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 845 is above the median of 60 across 7,703 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Phase 1a:
For combination dose escalation: participants must have received 3 or fewer prior lines of systemic anticancer therapy in the advanced/metastatic setting
Exclusion criteria
Any of the following cardiac examination abnormality:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: Ris-Rez
Biological: Ris-Rez · Drug: Cisplatin · Drug: Carboplatin · Biological: Atezolizumab · Biological: Pembrolizumab · Biological: Durvalumab · Biological: Cetuximab · Biological: Bevacizumab · Biological: Tarlatamab · Biological: Dostarlimab
Biological: Ris-Rez
Biological: Ris-Rez · Biological: Atezolizumab · Biological: Dostarlimab
Biological: Ris-Rez
Biological: Ris-Rez · Biological: Tarlatamab
Ris-Rez will be administered
Cisplatin will be administered
Carboplatin will be administered
Atezolizumab will be administered
Pembrolizumab will be administered
Durvalumab will be administered
Cetuximab will be administered
Bevacizumab will be administered
Tarlatamab will be administered
Dostarlimab will be administered
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)
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.
Time frame: Up to approximately 27 months
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)
cORR is defined as the proportion of participants who have confirmed CR or PR, per RECIST V1.1 by investigator
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
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)
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.
Time frame: Up to approximately 33 months
Not enrolling at this site — choose another above.
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2024 (actual). Primary completion is estimated for Oct 2028, 48 months after the start.
Of 677 industry-sponsored phase 1 interventional studies under Neoplasms, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 61. This study's planned 48 months is above that.
Counting every sponsor, half of 903 studies reached it within 40 months; a quarter within 23 and three quarters within 64.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Risvutatug rezetecan