GSK5533524 alone or with other treatments for adults with advanced solid tumors

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

This trial tests whether the new drug GSK5533524, given alone or with other therapies, is safe, tolerable, and can shrink or slow advanced solid tumors in adults who have no standard treatment options left.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 97 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: GlaxoSmithKline (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 2 sites (Montreal, Quebec and 1 other locations)
• Trial ID: NCT07438782 on ClinicalTrials.gov

What this trial studies

This first-in-human, phase 1 study uses dose-escalation and expansion cohorts to find a safe and tolerable dose of GSK5533524 given alone or in combination. Participants are adults with advanced or metastatic solid tumors that have progressed after standard therapies. The study will collect safety data, measure how the body absorbs and clears the drug (pharmacokinetics), monitor for immune reactions, and look for early signs of tumor shrinkage or disease control. Results will guide the recommended dose and schedule for later trials.

Who should consider this trial

Good fit: Adults (≥18) with histologically or cytologically confirmed advanced/metastatic solid tumors that progressed after standard therapy, with at least one measurable lesion per RECIST 1.1, ECOG performance status 0–1, and adequate organ function are the intended candidates.

Not a fit: Patients with uncontrolled or significant cardiac disease, pleural/abdominal effusions requiring intervention, or those who still have effective standard treatment options available are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, GSK5533524 could shrink or slow growth of some advanced solid tumors and offer a new option for patients who have exhausted standard treatments.

How similar studies have performed: This is a first-in-human trial for this compound, so the drug itself is untested in people, although other targeted agents have produced benefit in some refractory solid tumors.

Eligibility criteria

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.

Where this trial is running

Montreal, Quebec and 1 other locations

• GSK Investigational Site — Montreal, Quebec, Canada (Recruiting)
• GSK Investigational Site — Tokyo, Japan (Recruiting)

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center

Conditions Neoplasms; Solid Tumors; GSK5533524