A Study of GSK5764227 in Combination With Standard of Care (SoC) or Other Agents in Participants With Advanced Solid Tumors

Официальное название

A Phase 1b/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5764227 in Combination With Standard of Care (SoC) or Other Agents in Participants With Advanced Solid Tumors

Обзор

The goal of this clinical trial is to test a new medicine called GSK5764227, which delivers a toxin directly to cancer cells to destroy them while sparing healthy cells. The study will combine GSK5764227 with standard treatments to evaluate its safety, examine how the body processes it, check if it triggers any immune responses, and assess whether it can shrink or control cancer.

Вмешательства

• Препарат GSK5764227
  Participants will receive GSK5764227.
• Препарат Bevacizumab
  Participants will receive bevacizumab.
• Препарат Fluorouracil
  Participants will receive fluorouracil.
• Препарат leucovorin
  Participants will receive leucovorin.
• Препарат Enzalutamide
  Participants will receive enzalutamide.

Первичные конечные точки

• Number of participants with adverse events (AEs), Serious AEs (SAEs), AE of special interest (AESIs) and AEs leading to dose modifications [Срок оценки: Up to approximately 31 weeks]
• Number of participants with AEs, SAEs, AESIs, and AEs leading to dose modifications by severity [Срок оценки: Up to approximately 31 weeks]
• Number of participants with dose limiting toxicities (DLTs) [Срок оценки: Up to approximately 31 weeks]
• Number of participants with clinically significant changes in Vital Signs, Body Weight, Laboratory Tests [Hematology, Clinical Chemistry, Urinalysis], Cardiac Function [ECG], and Eastern Cooperative Oncology Group (ECOG) performance status [Срок оценки: Up to approximately 31 weeks]

Вторичные конечные точки (10)

• Plasma concentration of GSK5764227 [conjugated antibody and payload (GSK5757810) [Срок оценки: Up to approximately 112 weeks]
• Number of participants with anti-drug antibody (ADA) against GSK5764227 [Срок оценки: Up to approximately 112 weeks]
• Number of participants with neutralising antibody (NAb) against GSK5764227 [Срок оценки: Up to approximately 112 weeks]
• Titer of ADA against GSK5764227 [Срок оценки: Up to approximately 112 weeks]
• Objective Response Rate (ORR) [Срок оценки: Up to approximately 112 weeks]
• Disease control Rate (DCR18) [Срок оценки: Up to approximately 112 weeks]
• Duration of Response (DoR) [Срок оценки: Up to approximately 112 weeks]
• Progression free survival (PFS) [Срок оценки: Up to approximately 112 weeks]
• Radiographic progression-free survival (rPFS) [Срок оценки: Up to approximately 112 weeks]
• Prostate-specific antigen 50 (PSA50) [Срок оценки: Up to approximately 112 weeks]

Критерии участия

Критерии включения

• Has an ECOG performance status of 0 or 1, with no deterioration in the 2 weeks before first dose.
• Has adequate organ function.
• Has histologically confirmed unresectable adenocarcinoma or unresectable metastatic adenocarcinoma of the colon or rectum. (Cohort A)
• Histologically or cytologically confirmed adenocarcinoma of the prostate (Cohort B)

Критерии исключения

• Has a 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 disease.
• Has had any major surgery within 28 days prior to first dose.
• Has clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose.
• Has serious infection within 4 weeks prior to the first dose,
• Has untreated brain or central nervous system (CNS) metastases or brain/CNS metastases that have progressed
• Any evidence of current interstitial lung disease (ILD) or pneumonitis OR a prior history of ILD requiring high-dose glucocorticoids or non-infectious pneumonitis requiring high-dose glucocorticoids.
• Has a history of autoimmune disease that has required systemic treatments in the 2 years prior to screening.
• Has received immunosuppressive agents within 30 days prior to first dose of study intervention (or requires long-term \[30 days or longer\]). Low-dose corticosteroids (prednisone ≤10 milligrams (mg)/day or equivalent) may be administered.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 4 центра

• GSK Investigational Site — Barcelona
• GSK Investigational Site — Madrid
• GSK Investigational Site — Madrid
• GSK Investigational Site — Málaga

США · 1 центр

• GSK Investigational Site — Lake Success

Австралия · 1 центр

• GSK Investigational Site — Tugun

Идентификаторы

NCT: NCT07277270 · 300148 · 2025-522274-37-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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