NeoplasmsPhase 1NCT07438782
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
A Phase 1 study testing GSK5533524 in people with Neoplasms, run by GlaxoSmithKline at 20 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- GSK5533524
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 20 sitesin 8 countries
- Study dates
- 23 Mar 2026to 6 Feb 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 or intolerant to standard therapy, has exhausted all treatment options and is not considered a candidate for definitive radiotherapy.
- 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.
- 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.
- Has a life expectancy of at least 3 months.
Who cannot join
- 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.
Show all 20Show fewer
- 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 radiotherapy to the lungs, or to adjacent organs, within 6 months prior to the first dose of study intervention; 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.
Trial locations and contacts
20 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
20 sites in 8 countries
Spain5 sites, 5 recruiting
- Recruiting
GSK Investigational Site
Barcelona, 08035
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Madrid, 28009
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Madrid, 28027
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Madrid, 28041
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Madrid, 28050
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Japan4 sites, 4 recruiting
- Recruiting
GSK Investigational Site
Saitama, 350-1298
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Shizuoka, 411-8777
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Tokyo, 104-0045
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Tokyo, 135-8550
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Canada3 sites, 3 recruiting
- Recruiting
GSK Investigational Site
Montreal, Quebec, H2X 0A9
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Montreal, Quebec, H3T 1E2
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Toronto, Ontario, M5G 2M9
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
United States2 sites, 2 recruiting
- Recruiting
GSK Investigational Site
Philadelphia, Pennsylvania, 19107-4330
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
San Antonio, Texas, 78229-3307
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
France2 sites, 2 recruiting
- Recruiting
GSK Investigational Site
Bordeaux, 33076
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Villejuif, 94805
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
United Kingdom2 sites, 2 recruiting
- Recruiting
GSK Investigational Site
Cambridge, CB2 2QQ
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Edinburgh, EH4 2XU
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Denmark1 site, 1 recruiting
- Recruiting
GSK Investigational Site
København Ø, Capital Region, 2100
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Finland1 site, 1 recruiting
- Recruiting
GSK Investigational Site
Helsinki, 00029
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
About this study
Official title: 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.
- Conditions
- Neoplasms
- Being tested
- GSK5533524
- Keywords
- Solid Tumors, GSK5533524
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK5533524Drug
GSK5533524 will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Part 1a: GSK5533524 Dose Escalation | Experimental | Not described Receives: Drug: GSK5533524 |
| Part 1b: GSK5533524 Dose Expansion | Experimental | Not described Receives: Drug: GSK5533524 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1a: Number of participants with dose limiting toxicities (DLTs) per dose level
Measured: Up to 21 days
Part 1a: Number of participants with adverse events (AEs), serious adverse events (SAEs), by Severity per dose level
Measured: 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).
Measured: 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
Measured: Up to approximately 34 months
Part 1a: Objective Response Rate (ORR)
ORR is the proportion of participants with a BOR of CR or PR as assessed by the investigator according to RECIST 1.1.
Measured: Up to approximately 27 months
Part 1a & 1b: Duration of Response (DoR)
DoR is evaluated in participants who achieve a CR or PR, based on investigator assessment per RECIST 1.1.
Measured: Up to approximately 27 months
Part 1a & 1b: Pharmacokinetic (PK) Concentrations of GSK5533524 and its components
Measured: Up to approximately 27 months
Part 1a & 1b: Number of participants with Anti-drug antibodies (ADA) against GSK5533524
Measured: Up to approximately 27 months
Part 1a & 1b: Titers of ADA against GSK5533524
Measured: Up to approximately 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start23 Mar 2026
- Primary completion6 Feb 2029 (estimated)
- Study completion6 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 97 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07438782
- Sponsor's protocol ID
- 300163
- Other IDs
- 2025-524165-25, 2025
- Status last verified
- Sep 2026
- First submitted
- 23 Feb 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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/gsk-patient-level-data-sharing-july2025.pdf
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07438782
- Acronym / sponsor ID
- 300163
- Conditions
- Neoplasms
- Keywords
- Solid Tumors, GSK5533524
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 97 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- 6 Feb 2029 (estimated)
- Study completion
- 6 Feb 2029 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1a: GSK5533524 Dose Escalation | Experimental | Drug: GSK5533524 |
| Part 1b: GSK5533524 Dose Expansion | Experimental | Drug: GSK5533524 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 or intolerant to standard therapy, has exhausted all treatment options and is not considered a candidate for definitive radiotherapy.
- 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.
- Has an Eastern Cooperative Oncology Group performance status of 0 or 1 and no deterioration in the 2 weeks before enrollment.
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK5533524GSK5533524 will be administered. | Drug | Part 1a: GSK5533524 Dose Escalation, Part 1b: GSK5533524 Dose Expansion |
Primary outcome
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
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).
6 secondary outcomes
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
Part 1a: Objective Response Rate (ORR)
Time frame: Up to approximately 27 months
Part 1a & 1b: Duration of Response (DoR)
Time frame: Up to approximately 27 months
Part 1a & 1b: Pharmacokinetic (PK) Concentrations of GSK5533524 and its components
Time frame: 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
Part 1a & 1b: Titers of ADA against GSK5533524
Time frame: Up to approximately 27 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: Yes. 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/gsk-patient-level-data-sharing-july2025.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
20 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK5533524 in people with Neoplasms, run by GlaxoSmithKline at 20 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Spain, Japan, Canada, United States, France and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1a: Number of participants with dose limiting toxicities (DLTs) per dose level (time frame: Up to 21 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.