solide tumoren solid tumors
Conditions
Interventions
Treatment with GSK3359609 monotherapy (part 1B) or GSK3359609 in combination
with pembrolizumab or OX40 or chemotherapy with(out) pembrolizumab.
Sponsors
GlaxoSmithKline
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Male or female, age 18 years and above. • Histological or cytological documentation of an invasive malignancy that was diagnosed as locally advanced/metastatic or relapsed/refractory and is of one of the tumor types:mentioned in chapter 5.1, item 3 of the protocol. • Disease progressed after standard therapy for the specific tumor type, or standard therapy was ineffective, intolerable, or inappropriate, or if no further standard therapy exists. See protocol chapter 5.1, item 4 for details. • Agree to undergo a pre-treatment and on treatment biopsy and have disease amenable to biopsy required in PK/PD dose expansion cohorts. • Measurable disease. • ECOG performance status 0-1. • Life expectancy of at least 12 weeks. • Not pregnant or postmenopausal females and females of non-reproductive potential or Reproductive potential and agrees to follow a required contraceptive method (see protocol chapter 5.1, item 12 for details). • Male subjects with female partners of child bearing potential who agree to use one of the required methods of contraception.
Exclusion criteria
Exclusion criteria: • Prior cancer and non-cancer treatment, see protocol chapter 5.2, item 1, 6, 7 for details. • Bone marrow transplantation or other solid organ transplantation. • CNS metastases. Exception: see protocol chapter 5.2, item 5 for details. • Active autoimmune disease (refer to Appendix 2) that has required systemic treatment within the last 2 years. Replacement therapy is not considered a form of systemic treatment. • Medical condition requiring the use of systemic immunosuppressive medications within 28 days before the first dose of study treatment. Physiologic doses of corticosteroids for treatment of endocrinopathies or steroids with minimal systemic absorption may be continued if the subject is on a stable dose. • Active infection, known human immunodeficiency virus infection, or positive test for hepatitis B or hepatitis C. • Current active liver or biliary disease (exceptions see protocol chapter 5.2, item 12). • Within the past 6 months: acute diverticulitis, inflammatory bowel disease, intra-abdominal abscess, or gastrointestinal obstruction. • Live vaccine within 4 weeks. • Allergen desensitization therapy within 4 weeks. • History or evidence of cardiac and pulmonary abnormalities (see protocol chapter 5.2, items 17, 18 for details). • Within 6 months: uncontrolled symptomatic ascites or pleural effusions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events, dose limiting toxicities, dose modifications, PK and PD activity. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR), disease controll rate (DCR), progression free survival (PFS), overall survival (OS), Time to response (TTR), duration of response (DoR). | — |
Countries
Netherlands
Outcome results
None listed