A Study of GSK5764227 in Participants With Advanced Solid Tumors (EMBOLD) (PanTumor-101)

May 20, 2026 updated by: GlaxoSmithKline

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

845

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Rosario, Argentina, S2002
        • Completed
        • GSK Investigational Site
      • Viedma, Argentina, R8500ACE
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rubén Kowalyszyn
  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Courtney Coschi
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • John Hilton
        • Contact:
        • Contact:
      • Toronto, Ontario, Canada, M5G 1X6
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Albiruni Ryan Ryan Abdul Abdul Razak
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ramy Saleh
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Michel Pavic
        • Contact:
        • Contact:
  • France
      • Bordeaux, France, 33076
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Antoine Italiano
      • Lyon, France, 69373
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Philippe Cassier
        • Contact:
        • Contact:
      • Villejuif, France, 94805
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Yohann Loriot
        • Contact:
        • Contact:
  • Hong Kong
      • Pokfulam, Hong Kong
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Principal Investigator:
          • Thomas Chung-Cheung Yau
        • Contact:
      • Shatin, Hong Kong
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Herbert Ho Fung Loong
  • Israel
      • Jerusalem, Israel, 91031
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Daniela Katz
      • Jerusalem, Israel, 9112001
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yakir Rottenberg
      • Ramat Gan, Israel, 5266202
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hadas Gantz Sorotsky
      • Tel Aviv, Israel, 64239
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ravit Geva
  • Italy
      • Milan, Italy, 20141
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Giuseppe Curigliano
      • Naples, Italy, 80131
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Adriano Gravina
        • Contact:
        • Contact:
      • Roma, Italy, 00168
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gennaro Daniele
      • Verona, Italy, 37134
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Andrea Zivi
        • Contact:
        • Contact:
  • Japan
      • Aichi, Japan, 464-8681
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Kei Muro
        • Contact:
        • Contact:
      • Chiba, Japan, 277-8577
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shigehiro Koganemaru
      • Shizuoka, Japan, 411-8777
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Haruyasu Murakami
      • Tokyo, Japan, 104-0045
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Noboru Yamamoto
        • Contact:
        • Contact:
      • Tokyo, Japan, 135-8550
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Shigehisa Kitano
        • Contact:
        • Contact:
  • Panama
      • Panama City, Panama
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yong Loo Lau
  • South Korea
      • Gyeonggi-do, South Korea, 10408
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Young Joo Lee
      • Seoul, South Korea, 03080
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Dong-Wan Kim
        • Contact:
        • Contact:
      • Seoul, South Korea, 03722
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hye Ryun Kim
      • Seoul, South Korea, 135-710
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Principal Investigator:
          • Jin Seok Ahn
        • Contact:
  • Spain
      • Badajoz, Spain, 06080
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marta González Cordero
      • Barcelona, Spain, 08035
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Enriqueta Felip Font
      • Barcelona, Spain, 08036
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Iván Victoria Ruiz
        • Contact:
        • Contact:
      • Madrid, Spain, 28034
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • María Eugenia Olmedo García
      • Madrid, Spain, 28040
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Victor Moreno
        • Contact:
        • Contact:
      • Madrid, Spain, 28041
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jon Zugazagoitia Fraile
        • Contact:
        • Contact:
      • Málaga, Spain, 29010
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Javier García Corbacho
      • Valencia, Spain, 46026
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Oscar José Juan Vidal
        • Contact:
        • Contact:
      • Zaragoza, Spain, 50009
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dolores Isla Casado
  • Taiwan
      • Changhua, Taiwan, 500
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jin-Ching Lin
      • Kaohsiung City, Taiwan, 83301
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shau-Hsuan Li
      • Taichung, Taiwan, 40447
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Li-Yuan Bai
        • Contact:
        • Contact:
      • Tainan, Taiwan, 704
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • I-Ting Liu
      • Taipei, Taiwan, 10002
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chia-Chi Lin
      • Taipei, Taiwan, 11217
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Muh-Hwa Yang
  • United Kingdom
      • Edinburgh, United Kingdom, EH4 2XU
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Stefan Symeonides
        • Contact:
        • Contact:
      • Glasgow, United Kingdom, G12 0YN
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jeff Evans
        • Contact:
        • Contact:
      • London, United Kingdom, W1G 6AD
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Anja Williams
        • Contact:
        • Contact:
      • London, United Kingdom, WC1E 6AG
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sarah Benafif
      • Manchester, United Kingdom, M20 4BX
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Fiona Thistlethwaite
        • Contact:
        • Contact:
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christoph Oing
  • United States
    • California
      • Stanford, California, United States, 94063
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Christopher Chen
        • Contact:
        • Contact:
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Gerald Falchook
        • Contact:
        • Contact:
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Patricia LoRusso
        • Contact:
        • Contact:
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Sunil Babu
        • Contact:
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Leon Pappas
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wasif Saif
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Sanjay Goel
        • Contact:
        • Contact:
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Neal Shore
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Benjamin Garmezy
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vivian Jean Mikao Cline
      • Dallas, Texas, United States, 75230
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Reva Schneider
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • David Sommerhalder
        • Contact:
        • Contact:
      • Tyler, Texas, United States, 75702
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Donald Richards
    • Utah
      • West Valley City, Utah, United States, 84119
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • William McKean
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jedrzej Wykretowicz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria

  • 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:

  1. Participants with advanced/metastatic solid tumors.
  2. For monotherapy dose escalation: participants must have progressed on or become intolerant to all available SOC therapies.

  3. For combination dose escalation: participants must have received 3 or fewer prior lines of systemic anticancer therapy in the advanced/metastatic setting

    • 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.

Exclusion criteria

  • 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:

    1. Has QT interval, corrected for heart rate (QTc) >450 msec or QTc >480 msec for participants with bundle branch block.
    2. 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).
    3. 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.
    4. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 1a- Dose escalation- Combination therapy
Biological: Dostarlimab
Dostarlimab will be administered
Biological: Pembrolizumab
Pembrolizumab will be administered
Drug: Cisplatin
Cisplatin will be administered
Drug: Carboplatin
Carboplatin will be administered
Biological: Atezolizumab
Atezolizumab will be administered
Biological: Durvalumab
Durvalumab will be administered
Biological: Cetuximab
Cetuximab will be administered
Biological: Bevacizumab
Bevacizumab will be administered
Biological: Ris-Rez
Ris-Rez will be administered
Biological: Tarlatamab
Tarlatamab will be administered
Experimental: Phase 1a- Dose escalation- Monotherapy
Biological: Ris-Rez
Ris-Rez will be administered
Experimental: Phase 1b- Dose optimisation- Monotherapy
Biological: Ris-Rez
Ris-Rez will be administered
Experimental: Phase 1b- Dose optimisation- Combination therapy
Biological: Dostarlimab
Dostarlimab will be administered
Biological: Atezolizumab
Atezolizumab will be administered
Biological: Ris-Rez
Ris-Rez will be administered
Experimental: Phase 1b- Dose expansion- Monotherapy
Biological: Ris-Rez
Ris-Rez will be administered
Experimental: Phase 1b- Dose expansion- Combination therapy
Biological: Ris-Rez
Ris-Rez will be administered
Biological: Tarlatamab
Tarlatamab will be administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1a: Number of participants with Adverse Events (AEs)
Time Frame: Up to approximately 28 months
Up to approximately 28 months
Phase 1a: Number of participants with Dose Limiting Toxicities (DLTs)
Time Frame: Up to 21 days
Up to 21 days
Phase 1a: Number of participants with AEs leading to dose modifications
Time Frame: Up to approximately 28 months
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
Up to approximately 28 months
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
Up to approximately 30 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.
Up to approximately 27 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1a and Phase 1b: Number of participants with Antidrug antibody (ADA) or Neutralizing Antibody (NAb)
Time Frame: Up to approximately 30 months
Up to approximately 30 months
Phase 1b: Number of participants with AEs leading to dose modifications
Time Frame: Up to approximately 27 months
Up to approximately 27 months
Phase 1a and Phase 1b: Trough concentration (Ctrough) of GSK5757810 (small-molecule toxin)
Time Frame: Up to approximately 28 months
Up to approximately 28 months
Phase 1a: Duration of Response (DoR)
Time Frame: Up to approximately 33 months
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.
Up to approximately 33 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
Up to approximately 28 months
Phase 1a: Confirmed Objective Response Rate (cORR)
Time Frame: Up to approximately 33 months
cORR is defined as the proportion of participants who have confirmed CR or PR, per RECIST V1.1 by investigator
Up to approximately 33 months
Phase 1a: Disease control rate at 12 weeks (DCR12)
Time Frame: At 12 weeks
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
At 12 weeks
Phase 1b: Disease control rate at 12 weeks (DCR12)
Time Frame: At 12 weeks
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.
At 12 weeks
Phase 1b: Duration of Response (DoR)
Time Frame: Up to approximately 33 months
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.
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
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
Up to approximately 33 months
Phase 1b: Number of participants with AEs, SAEs and AESI by severity
Time Frame: Up to approximately 30 months
Up to approximately 30 months
Phase 1a and Phase 1b: Maximum concentration (Cmax) of Ris-Rez
Time Frame: Up to approximately 28 months
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
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
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
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
Up to approximately 28 months
Phase 1a and Phase 1b: Titers of ADA against Ris-Rez
Time Frame: Up to approximately 30 months
Up to approximately 30 months
Phase 1b: Progression-Free Survival (PFS)
Time Frame: Up to approximately 33 months
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.
Up to approximately 33 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2024

Primary Completion (Estimated)

October 16, 2028

Study Completion (Estimated)

June 8, 2029

Study Registration Dates

First Submitted

August 9, 2024

First Submitted That Met QC Criteria

August 9, 2024

First Posted (Actual)

August 13, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 223054
  • 2024-513663-10 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

IPD Sharing Time Frame

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.

IPD Sharing Access Criteria

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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