First Time in Human (FTIH) Study to Investigate the Safety and Preliminary Activity of GSK5533524 Alone or in Combination in Adult Participants With Advanced Solid Tumors

May 22, 2026 updated by: GlaxoSmithKline

A Phase 1, Open-label, Multicenter Study of GSK5533524 Alone or in Combination With Other Anti-cancer Agents, in Adult Participants With Selected Advanced Solid Tumors

The purpose of this study is to investigate a new drug GSK5533524 in adults with certain advanced cancers to find a safe dose and learn how well people tolerate it, so researchers can choose the best dose for the next stage of testing. The study will also check whether the drug can shrink tumours or slow cancer growth, monitor how the body absorbs and breaks down the drug, and look for any immune reactions that the body might develop against the treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

97

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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stephanie Lheureux
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • susie lau
      • Montreal, Quebec, Canada, H2X 0A9
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Principal Investigator:
          • Diane Provencher
        • Contact:
  • Japan
      • Saitama, Japan, 350-1298
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kosei Hasegawa
      • Tokyo, Japan, 104-0045
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kan Yonemori
      • Tokyo, Japan, 135-8550
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Shigehisa Kitano
        • Contact:
        • Contact:
  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Principal Investigator:
          • Ida Micaily
        • Contact:
    • Texas
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Drew Rasco
        • Contact:
        • Contact:

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:

  • Is at least 18 years of age or the legal age of consent
  • Has histologically or cytologically confirmed advanced/metastatic solid tumor that is refractory to standard therapy, for which no standard treatment is available, or who is intolerant to established standard of care therapies.
  • Has documented disease progression based on radiologic imaging, during or after most recent line of treatment.
  • Has at least one target lesion per RECIST 1.1 (participants in Part 1a backfill and Part 1b).
  • Has an Eastern Cooperative Oncology Group performance status of 0 or 1 and no deterioration in the 2 weeks before enrollment.
  • Has adequate organ function.

Exclusion Criteria:

  • Has a history of clinically significant or uncontrolled cardiac disease, acute myocardial infarction, congestive heart failure or clinically significant arrhythmia not controlled by Standard of care therapy.
  • Presence of pleural/abdominal effusion/ascites requiring clinical intervention; presence of pericardial effusion.
  • Has untreated brain or central nervous system metastases or metastases that have progressed
  • Has a Grade ≥2 corneal epithelial condition.
  • Has any active renal condition
  • Has a history of autoimmune disease that has required systemic treatments in the 2 years prior to screening.
  • Has ongoing adverse reaction(s) from prior therapy that has(have) not recovered to ≤Grade 1 or to the baseline status preceding prior therapy.
  • Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, or current ILD/pneumonitis.
  • Has a lung-specific intercurrent clinically significant illness
  • Has FEV1 <50% predicted
  • Has chronic enteritis or inflammatory bowel disease or any history of clinically significant bleeding of gastrointestinal tract or clinically significant obstruction and/or perforation and/or fistulae of GI tract.
  • Has a known hypersensitivity to any component of GSK5533524 or its excipients.
  • Has history of severe allergies, or severe infusion related reactions, or idiosyncrasy to recombinant humanized proteins.
  • Has received any cytotoxic chemotherapy drugs, or other anti-tumor drugs within 28 days prior to the first dose of study drug.
  • Has received locoregional radiation therapy within 2 weeks prior to the first dose of study drug; more than 30% of bone marrow irradiation or wide-field radiation therapy within 4 weeks prior to the first dose of study intervention.
  • Has received immunosuppressive agents or required long-term glucocorticoid therapy within 30 days prior to first dose of study treatment.
  • The use of concomitant medications known to prolong the QT/QTc interval or potentially cause torsades de pointes.
  • Has corrected QT interval by Fridericia formula (QTcF) >470 msec or QTcF >480 msec for participants with bundle branch block.
  • Has a left ventricular ejection fraction (LVEF) < 50%.
  • Has risk factors for prolonged QT/QTc or TdP, 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.

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: Part 1a: GSK5533524 Dose Escalation & Backfill
Drug: GSK5533524
GSK5533524 will be administered.
Experimental: Part 1b: GSK5533524 Dose Expansion
Drug: GSK5533524
GSK5533524 will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1a: Number of participants with dose limiting toxicities (DLTs) per dose level
Time Frame: Up to 21 days
Up to 21 days
Part 1a: Number of participants with adverse events (AEs), serious adverse events (SAEs), by Severity per dose level
Time Frame: Up to approximately 34 months
Up to approximately 34 months
Part 1b: Objective Response Rate (ORR)
Time Frame: Up to approximately 27 months
ORR is defined as the proportion of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
Up to approximately 27 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1a & 1b: Number of participants with adverse events (AEs), serious adverse events (SAEs), Treatment-Emergent AEs (TEAEs) by severity, Adverse Events of Special Interest (AESIs), and AEs leading to dose modifications and treatment discontinuation
Time Frame: Up to approximately 34 months
Up to approximately 34 months
Part 1a: Objective Response Rate (ORR)
Time Frame: Up to approximately 27 months
ORR is the proportion of participants with a BOR of CR or PR as assessed by the investigator according to RECIST 1.1.
Up to approximately 27 months
Part 1a & 1b: Duration of Response (DoR)
Time Frame: Up to approximately 27 months
DoR is evaluated in participants who achieve a CR or PR, based on investigator assessment per RECIST 1.1.
Up to approximately 27 months
Part 1a & 1b: Pharmacokinetic (PK) Concentrations of GSK5533524 and its components
Time Frame: Up to approximately 27 months
Up to approximately 27 months
Part 1a & 1b: Number of participants with Anti-drug antibodies (ADA) against GSK5533524
Time Frame: Up to approximately 27 months
Up to approximately 27 months
Part 1a & 1b: Titers of ADA against GSK5533524
Time Frame: Up to approximately 27 months
Up to approximately 27 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)

March 23, 2026

Primary Completion (Estimated)

February 6, 2029

Study Completion (Estimated)

February 6, 2029

Study Registration Dates

First Submitted

February 23, 2026

First Submitted That Met QC Criteria

February 23, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 300163
  • 2025-524165-25 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf

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 asset(s) with development terminated 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

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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