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Clinical Trials/JPRN-jRCT2080224700
JPRN-jRCT2080224700
Completed
Phase 1

A Phase I/Ib, Open-label, Multi-center, Study of DKY709 as a Single Agent and in Combination With PDR001 in Patients With Advanced Solid Tumors

ovartis Pharma. K.K.0 sites380 target enrollmentMay 27, 2019
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
ovartis Pharma. K.K.
Enrollment
380
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 27, 2019
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
ovartis Pharma. K.K.

Eligibility Criteria

Inclusion Criteria

  • •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

Exclusion Criteria

  • •\- 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

Outcomes

Primary Outcomes

Not specified

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