Study of Safety and Efficacy of DKY709 Alone or in Combination With PDR001 in Patients With Advan… (NCT03891953) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Study of Safety and Efficacy of DKY709 Alone or in Combination With PDR001 in Patients With Advanced Solid Tumors.
United States, Germany98 participantsStarted 2019-05-07
Plain-language summary
This is a phase I/Ib, open label study. The escalation portion will characterize the safety and tolerability of DKY709 and DKY709 in combination with PDR001 in subjects with NSCLC or melanoma who have received prior anti-PD-1/PD-L1 therapy, or subjects with NPC. After the determination of the MTD/RD for a particular treatment arm, dose expansion will further assess safety, tolerability, PK/PD, and anti-tumor activity of each regimen at the MTD/RD.
Who can participate
Age range18 Years – 100 Years
SexALL
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Inclusion criteria
✓. Signed informed consent must be obtained prior to participation in the study.
✓. Patients must be ≥18 years of age at the time of informed consent form (ICF) signature.
✓. Patients with advanced/metastatic cancer who have progressed despite having received standard therapy in the metastatic setting or are intolerant to standard therapy, and for whom no effective standard therapy is available
✓. In expansion: patient with measurable disease as determined by RECIST version 1.1,
✓. Dose escalation, patients must fit into one of the following groups:
✓. ECOG Performance Status ≤ 1
✓. Patients must have a site of disease amenable to core needle biopsy, and be a candidate for tumor biopsy according to the treating institution's guidelines. Patients must be willing to undergo a new tumor biopsy at baseline, and during therapy on the study. Exceptions may be considered after documented discussion with Novartis.
Exclusion criteria
✕. 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 2 weeks prior to study entry. Patients with treated brain metastases should be neurologically stable for at least 4 weeks prior to study entry and off steroids for at least 2 weeks before administration of any study treatment.
✕. History of severe hypersensitivity reactions to any ingredient of study drug(s) or other mAbs and/or their excipients.
What they're measuring
1
Safety of DKY709 single agent treatment or DKY709 in combination with PDR001.
Timeframe: 24 months
2
incidence of Dose Limiting Toxicities (DLTs)
Timeframe: 1 Month
3
Tolerability of DKY709 single agent treatment or DKY709 in combination with PDR001.