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A Phase I/II study of GSK5733584 in combination with anti-cancer therapies for advanced solid tumors
EU CTIS ID: 2024-517147-31-00
What this study is testing
Part A (Dose Exploration) To determine the safety and tolerability of GSK5733584 in combination with other anti-cancer treatments, in order to establish the Recommended Phase 2 Dose (s) for each combination treatment. Part B (Dose Expansion) To evaluate the anticancer activity of GSK5733584 in combination with other anti-cancer treatments
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants must be 18 years of age inclusive or older, at the time of signing the informed consent, or the legal age of consent in the jurisdiction in which the study is taking place
- Participants with pathologically confirmed advanced solid tumor (key local diagnostic molecular and/or immunophenotyping testing results/ tumor cell phenotype results for confirmed diagnosis should be provided) with no more than 4 lines of prior systemic therapies. Please note: a. Adjuvant ± neoadjuvant considered one line of therapy b. Maintenance therapy will be considered as part of the preceding line of therapy (i.e., not counted independently) c. Unplanned addition or switching to a new drug in a different class is considered a separate line of therapy. If an agent in a regimen is switched to another agent in the same class due to toxicity or intolerance (eg. hypersensitivity reaction) this is considered part of the same line (i.e. not counted independently).
- Requirements for tumor tissue samples: Archival or fresh tumor tissue is required for retrospective central assessment of B7H4 expression by IHC and other biomarker analysis. The archival tumor tissue should be from the most recent procedure (ideally obtained after the last anti-cancer treatment). If an archival tissue is not available a new biopsy should be performed, and the newly obtained tissue provided.
- Participants have at least one target lesion as assessed per the RECIST 1.1. A target lesion is defined as a measurable lesion that has not undergone locoregional treatment such as irradiation or that has unequivocal progression following locoregional treatment, with the longest diameter of ≥ 10 mm at baseline.
- Participants have a life expectancy of at least 12 weeks per investigator assessment based on disease burden and extent of supportive care needed.
- Is willing to use adequate contraception. Contraceptive use by men or women should be consistent with Protocol Section 10.4
You likely can't join if
- Has a second malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas [e.g., breast, cervix, bladder] that have been resected with no evidence of metastatic disease
- Has received treatment with any cytotoxic chemotherapy drugs or other anti-tumor drugs (including endocrine therapy, molecular targeted therapy, immunotherapy, biotherapy and investigational drug) within 30 days or 5 half-lives, whichever is shorter, of a medicinal product prior to the first dose of study drug; or need to continue these drugs during the study
- Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant
- Has known sensitivity to study intervention components, GSK5733584 (antibody-drug conjugate, antibody, free cytotoxin GSK5757810A) and combination partner or its excipients or other allergy that, in the opinion of the investigator, contraindicates participation in the study.
- Has any following cardiological examination abnormality : a. history in prior year of clinically significant or uncontrolled cardiac disease, acute myocardial infarction, New York Heart Association Class III or IV congestive heart failure [1994], or clinically significant arrhythmia not controlled by standard of care therapy. b. QTcF >450 msec or QTcF >480 msec for participants with bundle branch block
- Any evidence of current interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or non-infectious pneumonitis
See the full eligibility criteria
Who can join
- Participants must be 18 years of age inclusive or older, at the time of signing the informed consent, or the legal age of consent in the jurisdiction in which the study is taking place
- Participants with pathologically confirmed advanced solid tumor (key local diagnostic molecular and/or immunophenotyping testing results/ tumor cell phenotype results for confirmed diagnosis should be provided) with no more than 4 lines of prior systemic therapies. Please note: a. Adjuvant ± neoadjuvant considered one line of therapy b. Maintenance therapy will be considered as part of the preceding line of therapy (i.e., not counted independently) c. Unplanned addition or switching to a new drug in a different class is considered a separate line of therapy. If an agent in a regimen is switched to another agent in the same class due to toxicity or intolerance (eg. hypersensitivity reaction) this is considered part of the same line (i.e. not counted independently).
- Requirements for tumor tissue samples: Archival or fresh tumor tissue is required for retrospective central assessment of B7H4 expression by IHC and other biomarker analysis. The archival tumor tissue should be from the most recent procedure (ideally obtained after the last anti-cancer treatment). If an archival tissue is not available a new biopsy should be performed, and the newly obtained tissue provided.
- Participants have at least one target lesion as assessed per the RECIST 1.1. A target lesion is defined as a measurable lesion that has not undergone locoregional treatment such as irradiation or that has unequivocal progression following locoregional treatment, with the longest diameter of ≥ 10 mm at baseline.
- Participants have a life expectancy of at least 12 weeks per investigator assessment based on disease burden and extent of supportive care needed.
- Is willing to use adequate contraception. Contraceptive use by men or women should be consistent with Protocol Section 10.4
- Has an ECOG performance status of 0 to 1
- Participants with normal organ and bone marrow function as defined in Protocol Table 15
What rules you out
- Has a second malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas [e.g., breast, cervix, bladder] that have been resected with no evidence of metastatic disease
- Has received treatment with any cytotoxic chemotherapy drugs or other anti-tumor drugs (including endocrine therapy, molecular targeted therapy, immunotherapy, biotherapy and investigational drug) within 30 days or 5 half-lives, whichever is shorter, of a medicinal product prior to the first dose of study drug; or need to continue these drugs during the study
- Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant
- Has known sensitivity to study intervention components, GSK5733584 (antibody-drug conjugate, antibody, free cytotoxin GSK5757810A) and combination partner or its excipients or other allergy that, in the opinion of the investigator, contraindicates participation in the study.
- Has any following cardiological examination abnormality : a. history in prior year of clinically significant or uncontrolled cardiac disease, acute myocardial infarction, New York Heart Association Class III or IV congestive heart failure [1994], or clinically significant arrhythmia not controlled by standard of care therapy. b. QTcF >450 msec or QTcF >480 msec for participants with bundle branch block
- Any evidence of current interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or non-infectious pneumonitis
- Use of strong or moderate inhibitors or inducers of CYP3A4, CYP2D6, and inhibitors or inducers of P-gp, and BCRP within 14 days prior to the first dose of study drug; or in need of continuing treatment with these drugs during the study
- Has serious infections within 4 weeks prior to the first dose, including but not limited to infectious complications, bacteremia, severe pneumonia treated with intravenous antibiotics for ≥2 weeks; Participants who are receiving or have received prophylactic antibiotics (e.g., prophylaxis against urinary infections) are allowed
- Has chronic inflammatory bowel disease and/or bowel obstruction
- Has any serious and/or unstable medical condition (such as clinical symptoms of intestinal obstruction) or psychiatric disorder or other condition(s) (including laboratory assessment abnormalities) that could interfere with the participant’s safety, obtainment of informed consent, or compliance to the study procedures.
- Has a history of autoimmune disease that has required systemic treatments in the 2 years prior to screening (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy is not considered a form of systemic therapy (e.g., thyroid hormone for autoimmune thyroiditis or insulin is not exclusionary)
- Clinically significant bleeding symptoms, significant bleeding tendency, or bleeding tumors within 1 month prior to the first dose of study treatment
- Serious or poorly controlled hypertension, including history of hypertensive crisis, hypertensive encephalopathy; adjustment of antihypertensive medications due to poor blood pressure control within 2 weeks prior to the first dose of study treatment; systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg during screening period
- Has any active renal condition (e.g., infection, requirement for dialysis, or any other active significant renal condition or dehydrated condition that could affect the participant’s safety). Note: renal obstruction successfully managed by stenting is permitted
- Is pregnant or breastfeeding
- Has an ALT value >2.5x ULN and for participants with documented liver metastases/tumor infiltration has an ALT value >5x ULN.
- Has a total bilirubin value >1.5x ULN. NOTE: Participants with Gilbert’s syndrome can be included with a total bilirubin value <3x ULN, provided direct bilirubin is <1x ULN and participant otherwise meets entry criteria.
- Has received prior therapy with topoisomerase-1 inhibitors or ADC with topoisomerase-1 inhibitor warhead, or B7H4 targeted therapy
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- United States
- Turkey
- Panama
- United Kingdom
- Mexico
- Argentina
- Japan
- Brazil
- Korea, Republic of
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; United States; Turkey; Panama; United Kingdom; Mexico and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.