Phase I First Time in Human Open Label Study of GSK3745417 administered with and without Anticancer Agents in Participants with Advanced Solid Tumors (study 208850)
- Conditions
- solide tumorensolid tumors
- Registration Number
- NL-OMON56334
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 25
• 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.
.
• 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>PART 1A: Dose limiting toxicities, adverse events.</p><br>
- Secondary Outcome Measures
Name Time Method <p>PART 1A: Best objective response (RECIST 1.1). GSK3745417 concentrations in<br /><br>plasma and PK parameters.</p><br>