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GSK5533524 for Advanced Solid Tumors

This study is testing a new drug called GSK5533524 in adults with advanced solid tumors (cancers that start in organs like the breast, lung, or colon) that haven't responded to standard treatments or for which no standard treatment is available. The main goals are to find a safe dose of GSK5533524, see how well people tolerate it, and check if it can shrink tumors or slow cancer growth. Researchers will also monitor how your body handles the drug. You may be able to join if you are at least 18 years old and have an advanced solid tumor that meets the study criteria. The study is currently unclear on its recruitment status and plans to enroll 97 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 97 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for side effects for up to approximately 34 months and for tumor response for up to approximately 27 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07438782

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
GlaxoSmithKline
~97 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:GSK5533524

At a glance

Recruiting sites
16 of 16 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1a: Number of participants with dose limiting toxicities (DLTs) per dose level
Measured over Up to 21 days
+2 more outcomes measured

Conditions

Neoplasms

Explore related trials

Solid Neoplasm

NCT07438782

Where you'd take part

This study runs at 16 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • GSK Investigational Site

    Philadelphia, Pennsylvaniastudy coordinator listed

    Recruiting

  • GSK Investigational Site

    San Antonio, Texasstudy coordinator listed

    Recruiting

  • GSK Investigational Site

    Toronto, Ontario, Canadastudy coordinator listed

    Recruiting

  • GSK Investigational Site

    Montreal, Quebec, Canadastudy coordinator listed

    Recruiting

  • GSK Investigational Site

    Montreal, Quebec, Canadastudy coordinator listed

    Recruiting

  • GSK Investigational Site

    Helsinki, Finlandstudy coordinator listed

    Recruiting

  • GSK Investigational Site

    Saitama, Japanstudy coordinator listed

    Recruiting

  • GSK Investigational Site

    Shizuoka, Japanstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

US GSK Clinical Trials Call Center
[email protected]
877-379-3718
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Part 1a: Number of participants with dose limiting toxicities (DLTs) per dose levelUp to 21 days
  • Part 1a: Number of participants with adverse events (AEs), serious adverse events (SAEs), by Severity per dose levelUp to approximately 34 months
  • Part 1b: Objective Response Rate (ORR)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).