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

NCT07438782 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: 3001632025-524165-25
• Study Type: interventional
• Target: 97
• Locations: 0 countries
• Sites: N/A

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

Keywords

Solid Tumors; GSK5533524

Outcome Measures

Primary Outcomes (3)

• Part 1a: Number of participants with dose limiting toxicities (DLTs) per dose level

  Up to 21 days

• Part 1a: Number of participants with adverse events (AEs), serious adverse events (SAEs), by Severity per dose level

  Up to approximately 34 months

• Part 1b: Objective Response Rate (ORR)

  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 Outcomes (6)

• 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

  Up to approximately 34 months

• Part 1a: Objective Response Rate (ORR)

  Up to approximately 27 months

• Part 1a & 1b: Duration of Response (DoR)

  Up to approximately 27 months

• Part 1a & 1b: Pharmacokinetic (PK) Concentrations of GSK5533524 and its components

  Up to approximately 27 months

• Part 1a & 1b: Number of participants with Anti-drug antibodies (ADA) against GSK5533524

  Up to approximately 27 months

Study Arms (2)

Part 1a: GSK5533524 Dose Escalation & Backfill

EXPERIMENTAL

Drug: GSK5533524

Part 1b: GSK5533524 Dose Expansion

EXPERIMENTAL

Drug: GSK5533524

Interventions

GSK5533524 DRUG

GSK5533524 will be administered.

Part 1a: GSK5533524 Dose Escalation & Backfill; Part 1b: GSK5533524 Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 that required steroids, 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: February 27, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): February 13, 2029
• Study Completion (Estimated): February 13, 2029
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.