Clinical Trials List
Protocol Number223054
NCT Number(ClinicalTrials.gov Identfier)NCT06551142
Active
2025-06-18 - 2027-12-31
Phase I
Recruiting6
ICD-10C00.0
Malignant neoplasm of external upper lip
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9140.0
Malignant neoplasm of upper lip, vermilion border
A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of GSK5764227 as Monotherapy and in Combination in Participants With Advanced Solid Tumors
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Trial Applicant
GlaxoSmithKline
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/06/08
Investigators and Locations
Co-Principal Investigator
- 吳尚俊 Division of General Internal Medicine
- JIN-YUAN SHIH Division of General Internal Medicine
- 楊景堯 Division of General Internal Medicine
- Yu-Chieh Tsai Division of Hematology & Oncology
- 吳宗哲 Division of Hematology & Oncology
- James Chih-Hsin Yang Division of Hematology & Oncology
- 蔡子修 Division of General Internal Medicine
- CHAO-CHI HO CHAO-CHI HO Division of General Internal Medicine
- YEN-TING LIN Division of General Internal Medicine
- 許嘉林 Division of General Internal Medicine
- 廖斌志 Division of Hematology & Oncology
- Jih-Hsiang Lee Division of Hematology & Oncology
- 徐偉勛 醫學研究部
- 廖唯昱 Division of Hematology & Oncology
- FU-JEN HSUEH Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 李易濰 Division of Radiology
- 郭明濬 Division of Hematology & Oncology
- 蔡宗翰 Division of Hematology & Oncology
- Tai-Jan Chiu Division of Hematology & Oncology
- 黃詩喻 Division of Hematology & Oncology
- 吳佳哲 Division of Hematology & Oncology
- 林偉哲 Division of Radiology
- 黃泰霖 Division of Hematology & Oncology
- 林昶廷 Division of Hematology & Oncology
- 陳彥豪 Division of Hematology & Oncology
- Yu-Li Su Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Tien-Hua Chen Division of Hematology & Oncology
- Mu-Hsin Chang Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 陳珈妤 Division of Hematology & Oncology
- Ming-Yu Lien Division of Hematology & Oncology
- Che-Hung Lin Division of Hematology & Oncology
- Ching Yun Hsieh Division of Hematology & Oncology
- Yu-Min Liao Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Chia-Jui Yen
Co-Principal Investigator
- 劉奕廷 Division of Hematology & Oncology
- Shang-Yin Wu Division of Hematology & Oncology
- Yuh-Shyan Tsai Division of Urology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Neoplasms
Objectives
This trial aims to evaluate the safety, tolerability, pharmacokinetics, and clinical response of GSK5764227 as a monotherapy and in combination therapy, divided into Phase 1a (dose escalation) and Phase 1b (dose optimization/dose expansion). The Phase 1b trial in this application evaluates the clinical response, safety, tolerability, and pharmacokinetics of GSK5764227 in subjects with advanced solid tumors.
Test Drug
Injectable
Active Ingredient
GSK5764227
Dosage Form
270
Dosage
100mg
Endpoints
Evaluate the clinical response of GSK5764227 in patients with advanced solid tumors.
Inclution Criteria
Inclusion criteria
Male or female participants at least 18 years of age (≥18 years)
Participants with histologically confirmed advanced/metastatic solid tumors, as defined per study phase and cohort, as follows:
Phase 1a:
Participants with advanced/metastatic solid tumors.
For monotherapy dose escalation: participants must have progressed on or become intolerant to all available SOC therapies.
For combination dose escalation: participants must have received 3 or fewer prior lines of systemic anticancer therapy in the advanced/metastatic setting
Has at least 1 target lesion per RECIST 1.1, as determined by the investigator.
Has an ECOG performance status of 0 or 1, with no deterioration in the 2 weeks before first dose.
Has adequate organ function.
Where available, participants should provide a formalin fixed and paraffin embedded (FFPE) tumor sample from the most recent biopsy of primary cancer or from a metastatic site for central testing.
Male or female participants at least 18 years of age (≥18 years)
Participants with histologically confirmed advanced/metastatic solid tumors, as defined per study phase and cohort, as follows:
Phase 1a:
Participants with advanced/metastatic solid tumors.
For monotherapy dose escalation: participants must have progressed on or become intolerant to all available SOC therapies.
For combination dose escalation: participants must have received 3 or fewer prior lines of systemic anticancer therapy in the advanced/metastatic setting
Has at least 1 target lesion per RECIST 1.1, as determined by the investigator.
Has an ECOG performance status of 0 or 1, with no deterioration in the 2 weeks before first dose.
Has adequate organ function.
Where available, participants should provide a formalin fixed and paraffin embedded (FFPE) tumor sample from the most recent biopsy of primary cancer or from a metastatic site for central testing.
Exclusion Criteria
Exclusion criteria
Has ongoing adverse reaction(s) from prior therapy that has(have) not recovered to ≤Grade 1 or to the baseline status preceding prior therapy.
Prior treatment with orlotamab, enoblituzumab, I-Dxd, or other B7-H3 targeted agents.
Primary brain tumor or evidence of brain metastasis (unless meeting the following criteria at the same time: asymptomatic; medically stable for at least 4 weeks prior to initial dosing; no steroid treatment required for at least 4 weeks prior to initial dosing; and no midline shift due to herniation); or untreated progression due to brain metastasis or primary brain tumor during or after the last treatment prior to screening; or evidence of meningeal/brainstem involvement; or evidence of spinal cord compression (detected by radiographic examination, symptomatic or not).
Any of the following cardiac examination abnormality:
Has QT interval, corrected for heart rate (QTc) >450 msec or QTc >480 msec for participants with bundle branch block.
Evidence of current clinically significant arrhythmias or ECG abnormalities (e.g., complete left bundle branch block, third-degree atrioventricular [AV] block, second-degree AV block, PR interval >250 msec).
Risk factors of prolonged QTc or arrhythmia events, 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 or any concomitant medications that prolong the QT interval.
Left ventricular ejection fraction (LVEF) <50%.
Has severe, uncontrolled or active CV disorders, serious or poorly controlled hypertension, clinically significant bleeding symptoms or serious arteriovenous thromboembolic events
Participants with evidence of current ILD/non-infectious pneumonitis OR a prior history of ILD/non-infectious pneumonitis requiring high-dose glucocorticoids OR suspected ILD/non-infectious pneumonitis that cannot be ruled out by imaging.
Has a history of autoimmune disease that has required systemic treatments in the 2 years prior to screening. Participants with prior history of autoimmune disease must be discussed with the medical monitor. Replacement therapy is not considered a form of systemic therapy (e.g., thyroid hormone for autoimmune thyroiditis or insulin is not exclusionary).
Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant.
Has received prior anticancer therapy within 28 days of the first dose of study intervention or having to continue these medications during the study.
Has ongoing adverse reaction(s) from prior therapy that has(have) not recovered to ≤Grade 1 or to the baseline status preceding prior therapy.
Prior treatment with orlotamab, enoblituzumab, I-Dxd, or other B7-H3 targeted agents.
Primary brain tumor or evidence of brain metastasis (unless meeting the following criteria at the same time: asymptomatic; medically stable for at least 4 weeks prior to initial dosing; no steroid treatment required for at least 4 weeks prior to initial dosing; and no midline shift due to herniation); or untreated progression due to brain metastasis or primary brain tumor during or after the last treatment prior to screening; or evidence of meningeal/brainstem involvement; or evidence of spinal cord compression (detected by radiographic examination, symptomatic or not).
Any of the following cardiac examination abnormality:
Has QT interval, corrected for heart rate (QTc) >450 msec or QTc >480 msec for participants with bundle branch block.
Evidence of current clinically significant arrhythmias or ECG abnormalities (e.g., complete left bundle branch block, third-degree atrioventricular [AV] block, second-degree AV block, PR interval >250 msec).
Risk factors of prolonged QTc or arrhythmia events, 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 or any concomitant medications that prolong the QT interval.
Left ventricular ejection fraction (LVEF) <50%.
Has severe, uncontrolled or active CV disorders, serious or poorly controlled hypertension, clinically significant bleeding symptoms or serious arteriovenous thromboembolic events
Participants with evidence of current ILD/non-infectious pneumonitis OR a prior history of ILD/non-infectious pneumonitis requiring high-dose glucocorticoids OR suspected ILD/non-infectious pneumonitis that cannot be ruled out by imaging.
Has a history of autoimmune disease that has required systemic treatments in the 2 years prior to screening. Participants with prior history of autoimmune disease must be discussed with the medical monitor. Replacement therapy is not considered a form of systemic therapy (e.g., thyroid hormone for autoimmune thyroiditis or insulin is not exclusionary).
Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant.
Has received prior anticancer therapy within 28 days of the first dose of study intervention or having to continue these medications during the study.
The Estimated Number of Participants
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Taiwan
15 participants
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Global
160 participants
