SarcomaPhase 1/2NCT07602777
A Study Evaluating the Efficacy and Safety of Risvutatug Rezetecan in Participants With Advanced Sarcomas (EMBOLD Sarcoma-202)
A Phase 1/2 study testing Ris-Rez and G-CSF in people with Sarcoma, run by GlaxoSmithKline at 13 sites in 6 countries.
Trial summary
The main goal of this study is to test a new medicine, Risvutatug Rezetecan also called Ris-Rez. We want to see if this medicine can help people with certain types of cancer, whether its safe to use, how well people tolerate it, and how their bodies handle the drug (how its absorbed and broken down). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sarcoma
- What is being tested?
- Ris-Rez and G-CSF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 13 sitesin 6 countries
- Study dates
- 22 Jun 2026to 23 Nov 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants are eligible to be included in the study only if all of the following criteria apply
- Participants must be ≥ 12 years of age.
- Has histologically confirmed unresectable advanced or metastatic R/R OSA (Cohort 1) or unresectable advanced or metastatic STS (Cohort 2) that has progressed to at least one prior line of systemic therapy.
- Has documented disease progression on the last line of systemic treatment as confirmed by radiological imaging
- Has an ECOG performance status of 0 or 1, or Lansky PS/Karnofsky PS ≥ 70% for adolescent participants, with no deterioration in the 2 weeks prior to first dose/randomization.
- Has adequate organ function.
- All participants, or their legal guardians, must provide signed informed consent and agree to follow the study protocol before starting any study activities
Who cannot join
- Participants are excluded from the study if any of the following key exclusion criteria apply:
- Has received any prior therapy with an Antibody-drug-conjugates (ADC) with a TOPO1-inhibitor payload.
- Has known sensitivity to study intervention components or excipients or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
- Has severe, uncontrolled or active cardiovascular disorders.
- Known active infectious diseases requiring systemic treatment or known Human immunodeficiency virus (HIV).
- Has symptomatic brain metastases or untreated progression exclusively due to brain metastasis during or after the last treatment prior to screening, evidence of leptomeningeal/meningeal/brainstem metastasis or evidence of spinal cord metastases.
- Has received treatment with an investigational agent within 4 weeks of the first dose of study intervention.
- Is pregnant or breastfeeding.
Trial locations and contacts
13 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 6 countries
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
Japan3 sites, 3 recruiting
- Recruiting
GSK Investigational Site
Fukuoka, 812-8582
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
Hokkaido, 003-0804
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
Canada2 sites, 2 recruiting
- 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
Toronto, Ontario, M5G 2M9
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
Israel2 sites, 2 recruiting
- Recruiting
GSK Investigational Site
Jerusalem, 91120
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
United Kingdom2 sites, 2 recruiting
- Recruiting
GSK Investigational Site
London, NW1 2BU
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, Greater 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
United States1 site, 1 recruiting
- Recruiting
GSK Investigational Site
West Valley City, Utah, 84119-3602
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: Phase 1b/2 Study Evaluating the Efficacy and Safety of Risvutatug Rezetecan in Participants With Previously Treated Unresectable Advanced or Metastatic Sarcomas
The main goal of this study is to test a new medicine, Risvutatug Rezetecan also called Ris-Rez. We want to see if this medicine can help people with certain types of cancer, whether its safe to use, how well people tolerate it, and how their bodies handle the drug (how its absorbed and broken down). This research is for adolescents and adults who have either: Osteosarcoma, which is a type of bone cancer, or Soft Tissue Sarcoma, which is a type of cancer that starts in soft body tissues (like muscle, fat, or nerves). In both cancer types the cancer must have already been treated, but has come back or spread, and cant be removed by surgery
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
G-CSFBiological
G-CSF will be administered
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1A (Ris-Rez) | Experimental | Not described Receives: Biological: Ris-Rez |
| Cohort 1B [Ris-Rez + Granulocyte-Colony Stimulating Factor (G-CSF)] | Experimental | Not described Receives: Biological: Ris-Rez; Biological: G-CSF |
| Cohort 2 (Ris-Rez) | Experimental | Not described Receives: Biological: Ris-Rez |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort 1: Progression free survival rate at Week18 (PFS18)
PFS is defined as the time from the date of randomization until the date of documented disease progression or death due to any cause, whichever occurs first, as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
Measured: At Week 18
Cohort 1 & 2: Confirmed Objective Response Rate (ORR)
Confirmed ORR is defined as the proportion of participants who have achieved a confirmed Complete Response (CR) or Partial Response PR as assessed by investigator, according to RECIST 1.1
Measured: Up to approximately 98 weeks
Secondary outcomes (16)
Cohort 1 & 2: Number of participants with Adverse events (AEs) and serious AEs (SAEs) by severity
Measured: Up to approximately 179 weeks
Cohort 1 & 2: Number of participants with AEs/SAEs leading to dose modifications or study intervention discontinuation or death
Measured: Up to approximately 179 weeks
Cohort 1 & 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 179 weeks
Cohort 1 & 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 179 weeks
Cohort 1 & 2: Number of participants with a change from baseline in laboratory parameters (haematology and clinical chemistry)
Number of participants will be assessed
Measured: Baseline (Day-1) and up to approximately 179 weeks
Number of participants with a change from baseline in cardiac function [Electrocardiogram (ECG)]
Number of participants will be assessed
Measured: Baseline (Day-1) and up to approximately 179 weeks
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 179 weeks
Cohort 2: PFS rate at Week 18 (PFS18)
PFS is defined as the time from the date of randomization until the date of documented disease progression or death due to any cause, whichever occurs first, as assessed by the investigator according to RECIST 1.1
Measured: At Week 18
Cohort 1 & 2: Duration of response (DoR)
DoR is defined as the time from the date of the first documented objective response (CR/PR) that is subsequently confirmed, until the date of the first documented PD or death, whichever is earlier, as assessed by investigator according to RECIST 1.1
Measured: Up to approximately 179 weeks
Cohort 1 & 2: PFS rate at Week 30 (PFS30)
PFS is defined as the time from the date of randomization until the date of documented disease progression or death due to any cause, whichever occurs first, as assessed by the investigator according to RECIST 1.1
Measured: At Week 30
Cohort 1 & 2: PFS
PFS is defined as the time from the date of randomization until the date of documented disease progression or death due to any cause, whichever occurs first, as assessed by the investigator according to RECIST 1.1
Measured: Up to approximately 179 weeks
Cohort 1 & 2: Unconfirmed ORR
Unconfirmed ORR is defined as the proportion of participants who have achieved a response of CR or PR (without confirmation) as assessed by the investigator according to RECIST 1.1.
Measured: Up to approximately 179 weeks
Cohort 1 & 2: Observed pharmacokinetic (PK) concentration of Ris-Rez (conjugated antibody) and payload
Measured: Up to approximately 179 weeks
Cohort 1 & 2: Proportion of participants with positive and total Antidrug antibody (ADA) and Neutralizing Antibody (NAb) against Ris-Rez
Measured: Up to approximately 179 weeks
Cohort 1 & 2: Titers of ADA against Ris-Rez
Measured: Up to approximately 179 weeks
Cohort 1 & 2: Participant-reported experience on study treatment
Number of participants who reported their experience with study treatment using validated questionnaires will be measured
Measured: Up to approximately 179 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 start22 Jun 2026
- Primary completion5 Nov 2027 (estimated)
- Study completion23 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07602777
- Sponsor's protocol ID
- 300640
- Other IDs
- 2025-523997-18, 2025
- Status last verified
- Sep 2026
- First submitted
- 11 May 2026
- Last updated
- 1 Oct 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 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1b/2 Study Evaluating the Efficacy and Safety of Risvutatug Rezetecan in Participants With Previously Treated Unresectable Advanced or Metastatic Sarcomas
- ClinicalTrials.gov ID
- NCT07602777
- Acronym / sponsor ID
- 300640
- Conditions
- Sarcoma
- Keywords
- EMBOLD Sarcoma-202, Risvutatug Rezetecan, Ris-Rez, Sarcoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 22 Jun 2026 (actual)
- Primary completion
- 5 Nov 2027 (estimated)
- Study completion
- 23 Nov 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.
The main goal of this study is to test a new medicine, Risvutatug Rezetecan also called Ris-Rez. We want to see if this medicine can help people with certain types of cancer, whether its safe to use, how well people tolerate it, and how their bodies handle the drug (how its absorbed and broken down). This research is for adolescents and adults who have either: Osteosarcoma, which is a type of bone cancer, or Soft Tissue Sarcoma, which is a type of cancer that starts in soft body tissues (like muscle, fat, or nerves). In both cancer types the cancer must have already been treated, but has come back or spread, and cant be removed by surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1A (Ris-Rez) | Experimental | Biological: Ris-Rez |
| Cohort 1B [Ris-Rez + Granulocyte-Colony Stimulating Factor (G-CSF)] | Experimental | Biological: Ris-Rez, Biological: G-CSF |
| Cohort 2 (Ris-Rez) | Experimental | Biological: Ris-Rez |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Participants are eligible to be included in the study only if all of the following criteria apply
- Participants must be ≥ 12 years of age.
- Has histologically confirmed unresectable advanced or metastatic R/R OSA (Cohort 1) or unresectable advanced or metastatic STS (Cohort 2) that has progressed to at least one prior line of systemic therapy.
- Has documented disease progression on the last line of systemic treatment as confirmed by radiological imaging
- Has an ECOG performance status of 0 or 1, or Lansky PS/Karnofsky PS ≥ 70% for adolescent participants, with no deterioration in the 2 weeks prior to first dose/randomization.
Key exclusion criteria (8 listed)
- Participants are excluded from the study if any of the following key exclusion criteria apply:
- Has received any prior therapy with an Antibody-drug-conjugates (ADC) with a TOPO1-inhibitor payload.
- Has known sensitivity to study intervention components or excipients or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
- Has severe, uncontrolled or active cardiovascular disorders.
- Known active infectious diseases requiring systemic treatment or known Human immunodeficiency virus (HIV).
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 | Cohort 1A (Ris-Rez), Cohort 1B [Ris-Rez + Granulocyte-Colony Stimulating Factor (G-CSF)], Cohort 2 (Ris-Rez) |
| G-CSFG-CSF will be administered | Biological | Cohort 1B [Ris-Rez + Granulocyte-Colony Stimulating Factor (G-CSF)] |
Primary outcome
Cohort 1: Progression free survival rate at Week18 (PFS18)
Time frame: At Week 18
PFS is defined as the time from the date of randomization until the date of documented disease progression or death due to any cause, whichever occurs first, as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
Cohort 1 & 2: Confirmed Objective Response Rate (ORR)
Time frame: Up to approximately 98 weeks
Confirmed ORR is defined as the proportion of participants who have achieved a confirmed Complete Response (CR) or Partial Response PR as assessed by investigator, according to RECIST 1.1
16 secondary outcomes
Cohort 1 & 2: Number of participants with Adverse events (AEs) and serious AEs (SAEs) by severity
Time frame: Up to approximately 179 weeks
Cohort 1 & 2: Number of participants with AEs/SAEs leading to dose modifications or study intervention discontinuation or death
Time frame: Up to approximately 179 weeks
Cohort 1 & 2: Number of participants with a change from baseline in vital signs
Time frame: Baseline (Day-1) and up to approximately 179 weeks
Cohort 1 & 2: Number of participants with a change from baseline in body weight
Time frame: Baseline (Day-1) and up to approximately 179 weeks
Cohort 1 & 2: Number of participants with a change from baseline in laboratory parameters (haematology and clinical chemistry)
Time frame: Baseline (Day-1) and up to approximately 179 weeks
Number of participants with a change from baseline in cardiac function [Electrocardiogram (ECG)]
Time frame: Baseline (Day-1) and up to approximately 179 weeks
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 179 weeks
Cohort 2: PFS rate at Week 18 (PFS18)
Time frame: At Week 18
Cohort 1 & 2: Duration of response (DoR)
Time frame: Up to approximately 179 weeks
Cohort 1 & 2: PFS rate at Week 30 (PFS30)
Time frame: At Week 30
Cohort 1 & 2: PFS
Time frame: Up to approximately 179 weeks
Cohort 1 & 2: Unconfirmed ORR
Time frame: Up to approximately 179 weeks
Cohort 1 & 2: Observed pharmacokinetic (PK) concentration of Ris-Rez (conjugated antibody) and payload
Time frame: Up to approximately 179 weeks
Cohort 1 & 2: Proportion of participants with positive and total Antidrug antibody (ADA) and Neutralizing Antibody (NAb) against Ris-Rez
Time frame: Up to approximately 179 weeks
Cohort 1 & 2: Titers of ADA against Ris-Rez
Time frame: Up to approximately 179 weeks
Cohort 1 & 2: Participant-reported experience on study treatment
Time frame: Up to approximately 179 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 1 Oct 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.
13 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ris-Rez and G-CSF in people with Sarcoma, run by GlaxoSmithKline at 13 sites in 6 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 7 inclusion and 8 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 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France, Japan, Canada, Israel, United Kingdom and 1 more country. 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?
Cohort 1: Progression free survival rate at Week18 (PFS18) (time frame: At Week 18). The study lists 2 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 1 Oct 2026.