A Phase I Open Label Study of GSK3359609 Administered Alone and in Combination with Anticancer Agents in Subjects with Selected Advanced Solid Tumors (study 204691, ICOS)
- Conditions
- solide tumorensolid tumorscancer
- Registration Number
- NL-OMON52993
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 57
• 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.
• 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Adverse events, dose limiting toxicities, dose modifications, PK and PD<br /><br>activity.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Overall response rate (ORR), disease controll rate (DCR), progression free<br /><br>survival (PFS), overall survival (OS), Time to response (TTR), duration of<br /><br>response (DoR).</p><br>