solide tumoren solid tumors
Conditions
Interventions
PART 1A: Treatment with GSK3745417 alone.
Sponsors
GlaxoSmithKline
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Male or female, age 18 years and above. • Histologically or cytologically confirmed advanced/recurrent solid tumors, who have progressed on, be intolerant of, or ineligible for, all available therapies for which clinical benefit has been established. • Fresh tumor sample. For further details: see protocol section 5.1, item 5. • Measurable disease. For further details: see protocol section 5.1, item 6. • ECOG performance status 0-1. • Life expectancy of at least 12 weeks. • Adequate organ function. For further details: see protocol section 5.1, item 9. • Not pregnant or breastfeeding females and females of non-reproductive potential or reproductive potential and agrees to follow a required contraceptive method. For further details: see protocol section 5.1, item 11. .
Exclusion criteria
Exclusion criteria: • Malignancy other than disease under study. For further details: see protocol section 5.2, item 1. • CNS metastases. For further details: see protocol section 5.2, item 2. • Active autoimmune disease that has required systemic treatment within the last 2 years. Replacement therapy is not considered a form of systemic treatment. For further details: see protocol section 5.2, item 3. • Concurrent medical condition requiring the use of systemic immunosuppressive treatment within 28 days before the first dose of study treatment. For further details: see protocol section 5.2, item 4. • Current unstable liver or biliary disease per investigator assessment. For further details: see protocol section 5.2, item 5. • History of vasculitis. • Active infection requiring systemic therapy, known human immunodeficiency virus infection, positive test for hepatitis B or hepatitis C. See protocol section 5.2, item 8. • Within the past 6 months: acute diverticulitis, inflammatory bowel disease, intra-abdominal abscess, or gastrointestinal obstruction. • Allergen desensitization therapy within 4 weeks of starting study treatment. • History or evidence of cardiac and pulmonary abnormalities. For further details: see protocol section 5.2, item 12-15. • Within 6 months: uncontrolled symptomatic ascites or pleural or pericardial effusions. • Prior or concomitant therapies listed in protocol section 5.2, item 19-24. • Recent (within the past 6 months) history of any grade of immune myocarditis or pericarditis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PART 1A: Dose limiting toxicities, adverse events. | — |
Secondary
| Measure | Time frame |
|---|---|
| PART 1A: Best objective response (RECIST 1.1). GSK3745417 concentrations in plasma and PK parameters. | — |
Countries
Netherlands
Outcome results
None listed