Neoplasms, LungPhase 1/2NCT07602855
A Study of Risvutatug Rezetecan in Combination With Ivonescimab in Participants With Advanced Solid Tumors (EMBOLD PanTumour-103)
A Phase 1/2 study testing Risvutatug rezetecan and Ivonescimab in people with Neoplasms, Lung, run by GlaxoSmithKline at 4 sites in 2 countries.
Trial summary
This is an early-phase clinical study investigating a new combination treatment, Risvutatug rezetecan (Ris-Rez) given with ivonescimab for adults with advanced solid cancers. The study aims to determine: What dose(s) of Ris-Rez given with ivonescimab is safe and what are the side effects? How does the body handle the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Lung
- What is being tested?
- Risvutatug rezetecan and Ivonescimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 9 Sep 2026to 24 Dec 2029
- Phase
- Phase 1/2
- 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
- Participants are eligible to be included in the study only if all the following criteria apply:
- Male or female participants at least 18 years of age (≥18 years) at the time of signing the informed consent form (ICF).
- Participants with histologically confirmed advanced/metastatic solid tumors, irrespective of mutational status, as defined per cohort, as follows:
- ES-SCLC
- Histologically or cytologically confirmed SCLC (prior pathological diagnosis of complex SCLC [such as mixed SCLC and NSCLC] or transformed SCLC [NSCLC to SCLC] is not allowed)
- ES-SCLC [per Veterans Administration Lung Study Group (VALG) criteria] at study entry Squamous NSCLC or non-squamous NSCLC
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- Histologically or cytologically confirmed Squamous or Non-squamous NSCLC.
- Metastatic NSCLC (Stage IV), according to American Joint Committee on Cancer (AJCC) 8th edition,
- Has at least 1 target lesion per RECIST 1.1, as determined by the investigator. Measurable lesions that have been previously irradiated and have been shown to be progressing following irradiation may be considered as TLs.
- Has an ECOG performance status of 0 or 1, with no deterioration in the 2 weeks before first dose.
- Has a life expectancy of ≥ 3 months with ability to complete at least 4 cycles of study intervention.
- Has adequate organ function
- Is willing to use adequate contraception (contraceptive use by male and female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies).
- For dose expansion only: Tumor tissue (archival tumor tissue or a fresh biopsy) is required for all participants at screening. Tissue from a newly obtained fresh biopsy is preferred. If it is not feasible to obtain a fresh biopsy at screening, archival tumor tissue, (from the most recent biopsy (within 1 year), Formalin Fixation and Paraffin Embedding FFPE) block (preferred), or freshly cut slides is acceptable. If archival tissue is unavailable and it is not medically feasible to obtain fresh tissue, the medical monitor should be informed and exemption to the tissue requirement may be granted on a case-by-case basis. Tumor tissue is necessary for retrospective detection of B7 homolog 3 protein (B7-H3) expression and other biomarker analysis
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- Has ongoing adverse reaction(s) from prior therapy that has (have) not recovered to ≤Grade 1 or to baseline status preceding prior therapy (excluding alopecia, hearing loss, vitiligo, endocrinopathy managed with replacement therapy, and Grade 1 neuropathy).
- Has had major surgical procedures or serious trauma within 4 weeks prior to first dose, or plans for major surgical procedures within 4 weeks after the first dose (as determined by the investigator), or minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior to first dose.
- Has symptomatic Central Nervous System (CNS) metastases, CNS metastases with hemorrhagic features, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to first dose, potential need for CNS radiation within the first cycle, or leptomeningeal disease. Patients must have stopped corticosteroids or be on physiologic corticosteroid replacement therapy (prednisone ≤ 10 mg daily or equivalent).
- Has any of the following:
- QTc >450 msec or QTc >480 msec for participants with bundle branch block.
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- Evidence of current clinically significant arrhythmias or ECG abnormalities (e.g., complete left bundle branch block, third-degree atrioventricular block, second-degree atrioventricular block, PR interval >250 msec).
- 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; adjustment of antihypertensive medications due to poor blood pressure control within 2 weeks prior to the first dose; recurrent systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg during screening period.
- History of bleeding tendencies or coagulopathy and/or clinically significant bleeding symptoms or risk within 4 weeks prior to first dose, including but not limited to:
- Hemoptysis (defined as coughing up ≥ 1 teaspoon of fresh blood or small blood clots)
- Transient hemoptysis associated with diagnostic bronchoscopy is allowed.
- Nasal bleeding/epistaxis (bloody nasal discharge is allowed)
- Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable prior to first dose is not allowed.
- Participants with a history of esophageal or gastric varicose vein, severe ulcer, unhealed wound, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal hemorrhage within 6 months prior to first dose.
- History of any grade arterial thromboembolic event, Grade 3 and above venous thromboembolic event, as specified in National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) 6.0, hypertensive crisis, or hypertensive encephalopathy, within 12 months prior to the first dose.
- Serious infections within 4 weeks prior to the first dose, including but not limited to infectious complications, bacteremia, severe pneumonia treated with IV antibiotics for ≥ 2 weeks; active infections with therapeutic IV antibiotics within 2 weeks prior to the first dose or oral antibiotics within 1 week prior to the first dose. Participants who are receiving or have received prophylactic antibiotics (e.g., prophylaxis against urinary infections) are allowed.
- Any evidence of current Interstitial Lung Disease (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. Examples of suspected ILD/pneumonitis by imaging include the presence of lung parenchymal fibrosis, such as combined pulmonary fibrosis and emphysema (CPFE) and any radiographic features consistent with interstitial lung abnormalities, including but not limited to, extensive ground glass opacities, reticular opacities, traction bronchiectasis, and honeycombing.
- Participants with moderate to severe pulmonary disease or current clinically significant pulmonary compromise that, in the investigator's judgment, could jeopardize safety or study conduct. Examples include severe/poorly controlled asthma or Chronic Obstructive Pulmonary Disease (COPD) (including acute exacerbation of COPD within 4 weeks before first dose), restrictive lung disease, significant pleural effusion (clinically significant pleural effusion on Study Day 1. Baseline oxygen saturation < 90% on room air.) or structural lung abnormalities, pulmonary involvement from autoimmune/connective tissue disorders (e.g., rheumatoid arthritis, Sjögren's, sarcoidosis), or any condition requiring continuous supplemental oxygen or causing marked respiratory impairment (e.g., dyspnea at rest, greatly reduced exercise tolerance, or significantly decreased lung function). Treatment of pleural effusions to meet eligibility is permitted.
- History of allergy or hypersensitivity to Ris-Rez (antibody-drug conjugate (ADC), antibody, payload [GSK5757810]). History of severe allergies (e.g., anaphylactic shock), or severe infusion-related reactions (IRRs), or idiosyncrasy to recombinant humanized or mouse proteins.
- Has received prior anticancer therapy within 14 days of the first dose of study intervention or having to continue these medications during the study. Participants that had any macromolecular anticancer drug (including immunotherapies such as monoclonal antibodies and bispecific antibodies) within 28 days prior to the first dose of study intervention are excluded.
- History of local radiotherapy within 2 weeks prior to the first dose of study intervention; more than 30% of bone marrow irradiation or extensive radiotherapy within 4 weeks before the first dose of study intervention
- Has received any transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GM-CSF), or recombinant erythropoietin) within 14 days before enrollment. G-CSF prophylaxis prior to administration of Ris-Rez is permitted.
- Has received immunosuppressive agents within 30 days prior to first dose of study treatment (or requires long-term (30 days or longer) glucocorticoid therapy). Low-dose corticosteroids (prednisone ≤10 mg/day or equivalent) may be administered. Use of inhaled or topical steroids and prophylactic corticosteroids for procedures and pre-infusion prophylaxis are permitted.
- Participant with history of nephrotic syndrome or Grade 3 proteinuria or protein urine >1+ on dipstick or 24-h urine protein quantitation ≥ 1.0 g at Screening.
- History of abdominal or gastrointestinal fistula, tracheoesophageal fistula or any Grade 4 fistula, gastrointestinal perforation, or intra-abdominal abscess.
- Has any active renal condition (e.g., requirement for dialysis, or any other significant renal condition that could affect the participant's safety). Renal obstruction successfully managed by stenting is permitted.
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
United States3 sites, 3 recruiting
- Recruiting
GSK Investigational Site
Canton, Ohio, 44718
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
Los Angeles, California, 90027
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
Wilson, North Carolina, 27893-3484
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
Japan1 site, 1 recruiting
- Recruiting
GSK Investigational Site
Osaka, 573-1191
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 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Risvutatug Rezetecan in Combination With Ivonescimab in Participants With Advanced Solid Tumors
This is an early-phase clinical study investigating a new combination treatment, Risvutatug rezetecan (Ris-Rez) given with ivonescimab for adults with advanced solid cancers. The study aims to determine:
- What dose(s) of Ris-Rez given with ivonescimab is safe and what are the side effects?
- How does the body handle the drug(s)?
- What dose of Ris-Rez given with ivonescimab may work best and can improve the treatment of cancer?
- Conditions
- Neoplasms, Lung
- Being tested
- Risvutatug rezetecan, Ivonescimab
- Keywords
- Risvutatug rezetecan, Ris-Rez, Ivonescimab, EMBOLD, Neoplasms, Lung
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risvutatug rezetecanBiological
Risvutatug rezetecan will be administered
IvonescimabBiological
Ivonescimab will be administered
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: Dose escalation | Experimental | Not described Receives: Biological: Risvutatug rezetecan; Biological: Ivonescimab |
| Phase 2: Dose expansion | Experimental | Not described Receives: Biological: Risvutatug rezetecan; Biological: Ivonescimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 and Phase 2 Number of participants with Adverse events (AEs), Serious Adverse Events (SAEs) and Adverse events of special interest (AESIs)
Measured: Up to approximately 143 weeks
Phase 1 and Phase 2: Number of participants with AEs leading to dose modifications including study intervention discontinuation
Measured: Up to approximately 130 weeks
Phase 2: Number of participants with AEs leading to dose modifications or study intervention discontinuation
Measured: Up to approximately 130 weeks
Phase 1 and Phase 2: Number of participants with changes in safety parameters
Measured: Up to approximately 143 weeks
Phase 1: Number of participants with Dose Limiting Toxicities (DLT)
Measured: Up to 21 days
Phase 1 and Phase 2: Number of participants with a change from baseline in vital signs
Number of participants will be assessed
Measured: Baseline (Day -1) and up to approximately 143 weeks
Phase 1 and Phase 2: Number of participants with a change from baseline in body weight
Number of participants will be assessed
Measured: Baseline (Day -1) and up to approximately 143 weeks
Phase 1 and Phase 2: Number of participants with a change from baseline in laboratory parameters (hematology, clinical chemistry and urinalysis)
Number of participants will be assessed
Measured: Baseline (Day -1) and up to approximately 143 weeks
Phase 1 and Phase 2: Number of participants with a change from baseline in cardiac function [Electrocardiogram (ECG) and Echocardiogram (ECHO)]
Number of participants will be assessed
Measured: Baseline (Day -1) and up to approximately 143 weeks
Phase 1 and Phase 2: Number of participants with a change from baseline in Eastern Cooperative Oncology Group (ECOG) performance status
Number of participants will be assessed
Measured: Baseline (Day -1) and up to approximately 143 weeks
Phase 2: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 (RECIST) version (v) 1.1
Measured: Up to approximately 143 weeks
Secondary outcomes (12)
Phase 1: Maximum observed plasma concentration (Cmax) of Ris-Rez, rezetecan and ivonescimab
Measured: Up to approximately 169 weeks
Phase 1: Time to reach maximum concentration (Tmax) of Ris-Rez, GSK5757810 and ivonescimab
Measured: Up to approximately 169 weeks
Phase 1: Area under the curve (AUC) of Ris-Rez, GSK5757810 and ivonescimab
Measured: Up to approximately 169 weeks
Phase 1: Trough concentration (Ctrough) of Ris-Rez, GSK5757810 and ivonescimab
Measured: Up to approximately 169 weeks
Phase 1: 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 (RECIST) version (v) 1.1
Measured: Up to approximately 143 weeks
Phase 1 and Phase 2:Disease control rate at 12 weeks (DCR12)
DCR12 is as the proportion of participants who have achieved CR or PR, or stable disease (SD) for a duration of at least 11 weeks, per RECIST 1.1 by investigator assessment
Measured: At week 12
Phase 1and Phase 2: Duration of Response (DoR)
DoR is defined as the time from the date of first documented objective response (CR/PR) 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 169 weeks
Phase 2: Progression-free survival (PFS)
PFS is defined as the time from the date of first dose until the earliest date of documented disease progression according to RECIST 1.1 per investigator assessment
Measured: Up to approximately 169 weeks
Phase 1 and Phase 2: Overall Survival (OS)
OS is defined as the time from first dose to death from any cause
Measured: Up to approximately 169 weeks
Phase 2: Observed plasma concentration of Ris-Rez, GSK5757810 and ivonescimab
Measured: Up to approximately 169 weeks
Phase 2: Number of participants with Anti-drug antibodies (ADA) and Neutralizing antibody (NAb) for Ris-Rez and ivonescimab
Measured: Up to approximately 169 weeks
Phase 2: Titers of ADA to Ris-Rez and ivonescimab
Measured: Up to approximately 169 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start9 Sep 2026
- Primary completion22 Jun 2029 (estimated)
- Study completion24 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasms, LungStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07602855
- Sponsor's protocol ID
- 307890
- Other IDs
- 2026-525721-20
- Status last verified
- Sep 2026
- First submitted
- 15 May 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Risvutatug Rezetecan in Combination With Ivonescimab in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07602855
- Acronym / sponsor ID
- 307890
- Conditions
- Neoplasms, Lung
- Keywords
- Risvutatug rezetecan, Ris-Rez, Ivonescimab, EMBOLD, Neoplasms, Lung
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2026 (actual)
- Primary completion
- 22 Jun 2029 (estimated)
- Study completion
- 24 Dec 2029 (estimated)
- First posted
- 22 May 2026 (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.
This is an early-phase clinical study investigating a new combination treatment, Risvutatug rezetecan (Ris-Rez) given with ivonescimab for adults with advanced solid cancers. The study aims to determine:
- What dose(s) of Ris-Rez given with ivonescimab is safe and what are the side effects?
- How does the body handle the drug(s)?
- What dose of Ris-Rez given with ivonescimab may work best and can improve the treatment of cancer?
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Dose escalation | Experimental | Biological: Risvutatug rezetecan, Biological: Ivonescimab |
| Phase 2: Dose expansion | Experimental | Biological: Risvutatug rezetecan, Biological: Ivonescimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Participants are eligible to be included in the study only if all the following criteria apply:
- Male or female participants at least 18 years of age (≥18 years) at the time of signing the informed consent form (ICF).
- Participants with histologically confirmed advanced/metastatic solid tumors, irrespective of mutational status, as defined per cohort, as follows:
- ES-SCLC
- Histologically or cytologically confirmed SCLC (prior pathological diagnosis of complex SCLC [such as mixed SCLC and NSCLC] or transformed SCLC [NSCLC to SCLC] is not allowed)
Key exclusion criteria (29 listed)
- Has ongoing adverse reaction(s) from prior therapy that has (have) not recovered to ≤Grade 1 or to baseline status preceding prior therapy (excluding alopecia, hearing loss, vitiligo, endocrinopathy managed with replacement therapy, and Grade 1 neuropathy).
- Has had major surgical procedures or serious trauma within 4 weeks prior to first dose, or plans for major surgical procedures within 4 weeks after the first dose (as determined by the investigator), or minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior to first dose.
- Has symptomatic Central Nervous System (CNS) metastases, CNS metastases with hemorrhagic features, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to first dose, potential need for CNS radiation within the first cycle, or leptomeningeal disease. Patients must have stopped corticosteroids or be on physiologic corticosteroid replacement therapy (prednisone ≤ 10 mg daily or equivalent).
- Has any of the following:
- Has severe, uncontrolled or active CV disorders
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 |
|---|---|---|
| Risvutatug rezetecanRisvutatug rezetecan will be administered | Biological | Phase 1: Dose escalation, Phase 2: Dose expansion |
| IvonescimabIvonescimab will be administered | Biological | Phase 1: Dose escalation, Phase 2: Dose expansion |
Primary outcome
Phase 1 and Phase 2 Number of participants with Adverse events (AEs), Serious Adverse Events (SAEs) and Adverse events of special interest (AESIs)
Time frame: Up to approximately 143 weeks
Phase 1 and Phase 2: Number of participants with AEs leading to dose modifications including study intervention discontinuation
Time frame: Up to approximately 130 weeks
Phase 2: Number of participants with AEs leading to dose modifications or study intervention discontinuation
Time frame: Up to approximately 130 weeks
Phase 1 and Phase 2: Number of participants with changes in safety parameters
Time frame: Up to approximately 143 weeks
Phase 1: Number of participants with Dose Limiting Toxicities (DLT)
Time frame: Up to 21 days
Phase 1 and Phase 2: Number of participants with a change from baseline in vital signs
Time frame: Baseline (Day -1) and up to approximately 143 weeks
Number of participants will be assessed
Phase 1 and Phase 2: Number of participants with a change from baseline in body weight
Time frame: Baseline (Day -1) and up to approximately 143 weeks
Number of participants will be assessed
Phase 1 and Phase 2: Number of participants with a change from baseline in laboratory parameters (hematology, clinical chemistry and urinalysis)
Time frame: Baseline (Day -1) and up to approximately 143 weeks
Number of participants will be assessed
Phase 1 and Phase 2: Number of participants with a change from baseline in cardiac function [Electrocardiogram (ECG) and Echocardiogram (ECHO)]
Time frame: Baseline (Day -1) and up to approximately 143 weeks
Number of participants will be assessed
Phase 1 and Phase 2: Number of participants with a change from baseline in Eastern Cooperative Oncology Group (ECOG) performance status
Time frame: Baseline (Day -1) and up to approximately 143 weeks
Number of participants will be assessed
Phase 2:Confirmed Objective Response Rate (cORR)
Time frame: Up to approximately 143 weeks
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 (RECIST) version (v) 1.1
12 secondary outcomes
Phase 1: Maximum observed plasma concentration (Cmax) of Ris-Rez, rezetecan and ivonescimab
Time frame: Up to approximately 169 weeks
Phase 1: Time to reach maximum concentration (Tmax) of Ris-Rez, GSK5757810 and ivonescimab
Time frame: Up to approximately 169 weeks
Phase 1: Area under the curve (AUC) of Ris-Rez, GSK5757810 and ivonescimab
Time frame: Up to approximately 169 weeks
Phase 1: Trough concentration (Ctrough) of Ris-Rez, GSK5757810 and ivonescimab
Time frame: Up to approximately 169 weeks
Phase 1: Confirmed Objective Response Rate (cORR)
Time frame: Up to approximately 143 weeks
Phase 1 and Phase 2:Disease control rate at 12 weeks (DCR12)
Time frame: At week 12
Phase 1and Phase 2: Duration of Response (DoR)
Time frame: Up to approximately 169 weeks
Phase 2: Progression-free survival (PFS)
Time frame: Up to approximately 169 weeks
Phase 1 and Phase 2: Overall Survival (OS)
Time frame: Up to approximately 169 weeks
Phase 2: Observed plasma concentration of Ris-Rez, GSK5757810 and ivonescimab
Time frame: Up to approximately 169 weeks
Phase 2: Number of participants with Anti-drug antibodies (ADA) and Neutralizing antibody (NAb) for Ris-Rez and ivonescimab
Time frame: Up to approximately 169 weeks
Phase 2: Titers of ADA to Ris-Rez and ivonescimab
Time frame: Up to approximately 169 weeks
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 23 Sep 2026.
- Individual participant dataSharing planned: Yes. Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
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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.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Risvutatug rezetecan and Ivonescimab in people with Neoplasms, Lung, run by GlaxoSmithKline at 4 sites in 2 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 14 inclusion and 29 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 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Japan. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 1 and Phase 2 Number of participants with Adverse events (AEs), Serious Adverse Events (SAEs) and Adverse events of special interest (AESIs) (time frame: Up to approximately 143 weeks). The study lists 11 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 23 Sep 2026.