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Ris-Rez

Phase 3

Neoplasms, Lung | Monoclonal antibody | Oncology |GSK plc|Last Updated: Aug 31, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment420

FDA Designations

No designations recorded

Clinical trial landscape

Ris-Rez · 4 trials · 4 indications

Phase 3 1Phase 1 3
NCT07099898A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC)Neoplasms, Lung
RECRUITING420 Analytics
PHASE3RECRUITING
A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC)
Neoplasms, LungUnlock trial analytics

Study Endpoints

Primary Endpoints

Overall Survival (OS)
Up to approximately 113 weeks

OS is defined as the time from the date of randomization to the date of death by any cause

Confirmed Objective Response Rate (cORR)
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

Number of participants with Adverse events (AEs), Serious Adverse Events (SAEs) and Adverse events of special interest (AESIs) by severity
Up to approximately 143 weeks
Number of participants with AEs leading to dose modifications or study intervention discontinuation
Up to approximately 130 weeks
Number of participants with changes in safety parameters
Up to approximately 143 weeks

Number of participants will be assessed

Number of participants with Dose Limiting Toxicities (DLT)
Up to 21 days
Number of participants with a change from baseline in vital signs
Baseline (Day -1) and up to approximately 143 weeks

Number of participants will be assessed

Number of participants with a change from baseline in body weight
Baseline (Day -1) and up to approximately 143 weeks

Number of participants will be assessed

Number of participants with a change from baseline in laboratory parameters (hematology, clinical chemistry and urinalysis)
Baseline (Day -1) and up to approximately 143 weeks

Number of participants will be assessed

Number of participants with a change from baseline in cardiac function [Electrocardiogram (ECG) and Echocardiogram (ECHO)
Baseline (Day -1) and up to approximately 143 weeks

Number of participants will be assessed

Number of participants with a change from baseline in Eastern Cooperative Oncology Group (ECOG) performance status
Baseline (Day -1) and up to approximately 143 weeks

Number of participants will be assessed

Cohort 1: Progression free survival rate at Week18 (PFS18)
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)
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

Phase 1a: Number of participants with Adverse Events (AEs)
Up to approximately 28 months
Phase 1a: Number of participants with Dose Limiting Toxicities (DLTs)
Up to 21 days
Phase 1a: Number of participants with AEs, serious adverse events (SAEs) and adverse events of special interest (AESIs) by severity
Up to approximately 30 months
Phase 1a: Number of participants with AEs leading to dose modifications
Up to approximately 28 months
Phase 1a: Number of participants with changes in vital signs, body weight, laboratory tests, electrocardiogram (ECG) and Eastern Cooperative Oncology Group (ECOG) performance status
Up to approximately 28 months
Phase 1b: Confirmed Objective Response Rate (cORR)
Up to approximately 27 months

cORR is defined as the proportion of participants who have confirmed Complete response (CR) or Partial response (PR), assessed by the investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST V1.1) criteria or other imaging criteria for defined tumor types.

Secondary Endpoints

Objective Response Rate (ORR)
Up to approximately 139 weeks
Duration of Response (DoR)
Up to approximately 139 weeks
Progression-free survival (PFS)
Up to approximately 139 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Ris-RezEXPERIMENTAL -
TopotecanACTIVE_COMPARATOR -
Ris-Rez + IvonescimabEXPERIMENTAL -
Cohort 1A (Ris-Rez)EXPERIMENTAL -
Cohort 1B [Ris-Rez + Granulocyte-Colony Stimulating Factor (G-CSF)]EXPERIMENTAL -
Cohort 2 (Ris-Rez)EXPERIMENTAL -
Phase 1a- Dose escalation- MonotherapyEXPERIMENTAL -
Phase 1a- Dose escalation- Combination therapyEXPERIMENTAL -
Phase 1b- Dose optimisation- MonotherapyEXPERIMENTAL -
Phase 1b- Dose optimisation- Combination therapyEXPERIMENTAL -
Phase 1b- Dose expansion- MonotherapyEXPERIMENTAL -
Phase 1b- Dose expansion- Combination therapyEXPERIMENTAL -

Interventions

NameTypeDescription
Ris-RezBIOLOGICALRis-Rez will be administered
TopotecanDRUGTopotecan will be administered
IvonescimabBIOLOGICALIvonescimab will be administered
G-CSFBIOLOGICALG-CSF will be administered
CisplatinDRUGCisplatin will be administered
CarboplatinDRUGCarboplatin will be administered
AtezolizumabBIOLOGICALAtezolizumab will be administered
PembrolizumabBIOLOGICALPembrolizumab will be administered
DurvalumabBIOLOGICALDurvalumab will be administered
CetuximabBIOLOGICALCetuximab will be administered
BevacizumabBIOLOGICALBevacizumab will be administered
TarlatamabBIOLOGICALTarlatamab will be administered
DostarlimabBIOLOGICALDostarlimab will be administered
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites132

Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: * Adults \>18 or the minimum legal adult age at the time the informed consent form is signed * Has histologically or cytologically confirmed extensive-stage small cell lung cancer...

Countries:United StatesArgentinaAustraliaBrazilBulgariaCanadaFinlandFranceGermanyGreeceHungaryIrelandIsraelItalyJapanMexicoPolandPortugalRomaniaSouth KoreaSpainSwedenSwitzerlandTurkey (Türkiye)United KingdomHong KongPanamaTaiwan
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Recent Changes (Last 90 Days)

LOWAug 31, 2026NCT07099898lastUpdatePostDate: changed
LOWAug 31, 2026NCT07099898lastUpdatePostDate: changed
LOWJul 29, 2026NCT07099898lastUpdatePostDate: changed
LOWJul 29, 2026NCT07099898lastUpdatePostDate: changed
LOWJul 15, 2026NCT07602777Status: NOT_YET_RECRUITING → RECRUITING
LOWJul 15, 2026NCT07602777Status: NOT_YET_RECRUITING → RECRUITING

Frequently asked questions about Ris-Rez

What is Ris-Rez used for?

Ris-Rez is an investigational monoclonal antibody being developed for oncology indications, including solid tumors, sarcoma, and lung cancer. It is currently in clinical development for advanced solid tumors, relapsed small cell lung cancer, advanced sarcomas, and in combination with ivonescimab for advanced solid tumors.

Who makes Ris-Rez?

Ris-Rez is being developed by GSK plc, a global biopharma company traded on the London Stock Exchange under the ticker GSK. GSK is conducting multiple clinical trials of Ris-Rez across various oncology indications.

What phase is Ris-Rez in?

Ris-Rez is in Phase 1 clinical development for most indications, including advanced solid tumors and sarcomas. However, one trial in relapsed small cell lung cancer is listed as Phase 3. The drug is investigational and not yet approved by regulatory authorities.

What clinical trials is Ris-Rez in?

Ris-Rez is being studied in four clinical trials: NCT06551142 for advanced solid tumors, NCT07099898 for relapsed small cell lung cancer, NCT07602777 for advanced sarcomas, and NCT07602855 in combination with ivonescimab for advanced solid tumors. All trials are recruiting or not yet recruiting.

Is Ris-Rez the same as GSK5764227 or Risvutatug Rezetecan?

Yes, Ris-Rez is also known as GSK5764227 and Risvutatug Rezetecan. Clinical trial NCT06551142 uses the name GSK5764227, while trials NCT07602777 and NCT07602855 use the name Risvutatug Rezetecan.