Recruiting
Phase 1

GSK5533524

Sponsor:

GlaxoSmithKline

Code:

NCT07438782

Conditions

Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

GSK5533524

Study Details

Brief summary:

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.

Conditions

Neoplasms

Study ID

NCT07438782

Start date

Mar 23, 2026

Status verified date

Jul, 2026

Completion date

Feb 6, 2029

Anticipated

Primary completion date

Feb 6, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

97 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1a: GSK5533524 Dose Escalation & Backfill

experimental: Part 1b: GSK5533524 Dose Expansion

Interventions

GSK5533524

GSK5533524 will be administered.

Primary outcome measure

  • Part 1a: Number of participants with dose limiting toxicities (DLTs) per dose level [ Time Frame: 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 ]
  • Part 1b: Objective Response Rate (ORR) [ Time Frame: Up to approximately 27 months ]

Central Contacts and Locations

Central contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

+44 (0) 20 89904466GSKClinicalSupportHD@gsk.com

Locations

GSK Investigational Site

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Ida Micaily

GSK Investigational Site

Recruiting

San Antonio, Texas, United States, 78229

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Drew Rasco

GSK Investigational Site

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Stephanie Lheureux

GSK Investigational Site

Recruiting

Montreal, Quebec, Canada, H2X 0A9

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Diane Provencher

GSK Investigational Site

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

susie lau

More Information

Sponsor

GlaxoSmithKline

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Keywords

  • Solid Tumors
  • GSK5533524

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by GlaxoSmithKline on 2026-07-21.