NL-OMON56334RecruitingNot Applicable
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) - study 208850
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- GlaxoSmithKline
- Enrollment
- 25
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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
- •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
- •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
- •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.
Investigators
Similar Trials
Suspended
Phase 1
Phase 1 First Time in Human (FTIH), Open Label Study of GSK3745417 Administered to Participants With Advanced Solid Tumorsadvanced solid tumorsJPRN-jRCT2031220077Ishibashi Hideyasu300
Recruiting
Phase 1
Phase 1 First-Time-in-Human, Open-Label Study of GSK4381562 Administered to Participants with Advanced Solid TumorsSelected Advanced Solid TumorsJPRN-jRCT2031220403Ishibashi Hideyasu126
Recruiting
Phase 1
Study of the Safety and Effectiveness of GSK6097608 in Participants With Advanced Solid Tumorsadvanced solid tumorsJPRN-jRCT2031210338Ishibashi Hideyasu184
Completed
Not Applicable
A phase I/IIa open-label First-in-Human study to assess safety and pharmacokinetics and explore biomarker effects of topical ionic contra-viral therapy (ICVT) comprised of digoxin and furosemide in subjects with cutaneous warts.cutaneous warts10014982NL-OMON41213Cutanea Life Sciences12
Active, not recruiting
Not Applicable
A study in volunteers with cutaneous warts to assess safety and the effect of the body on topical ionic contra-viral therapy (ICVT) comprised of digoxin and furosemide.Cutaneous wartsMedDRA version: 16.1Level: HLTClassification code 10033724Term: Papilloma viral infectionsSystem Organ Class: 100000004862EUCTR2013-005569-38-NLCutanea Life Sciences