Study of safety and efficacy of DKY709 alone or in combination with PDR001 in patients with advanced solid tumors
- Conditions
- advanced or metastatic NSCLC, melanoma, NPC, mssCRC, or TNBC
- Registration Number
- JPRN-jRCT2080224700
- Lead Sponsor
- ovartis Pharma. K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 380
Subjects with advanced/metastatic NSCLC, cutaneous melanoma, NPC, mssCRC or TNBC as determined by local testing, with measurable disease as determined by RECIST version 1.1. Tumor lesions previously irradiated or subjected to other loco-regional therapy will only be considered measurable if there is documented disease progression at the treated site prior to study entry.
- Subjects should have received standard therapy in the metastatic setting, are intolerant to standard therapy, or no effective therapy is available
- Must have a site of disease amenable to core needle biopsy, and be a candidate for tumor biopsy according to the treating institution guidelines. Subject must be willing to undergo a new tumor biopsy at screening, and during therapy on the study. Exceptions may be considered after documented discussion with Novartis. Patients participating in the neurology sub-study will not have tumor biopsy samples collected
- Patient has received prior treatment with an IKZF2 targeted agent.
- Presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require local CNS-directed therapy (such as radiotherapy or surgery), or increasing doses of corticosteroids within the prior 2 weeks.
- History of severe hypersensitivity reactions to any ingredient of study drug(s) and other mAbs and/or their excipients.
- Impaired cardiac function or clinically significant cardiac disease.
- HIV infection.
- Patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
- Active, known or suspected autoimmune disease.
- Presence or history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation or drug-induced pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention).
- Subjects with symptomatic peripheral neuropathy limiting instrumental activities of daily living
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method