NL-OMON53097
Completed
Not Applicable
A phase I-Ib/II, open-label, multi-center study of the safety and efficacy of MBG453 as single agent and in combination with PDR001 in adult patients with advanced malignancies - CMBG453X2101
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- ovartis
- Enrollment
- 33
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 64 (—)
Inclusion Criteria
- •\* Phase I\-Ib part: Advanced/metastatic solid tumors, with (non)\-measurable
- •disease, who have progressed despite standard therapy or are intolerant of
- •standard therapy, or for whom no standard therapy exists, and who did not
- •receive prior anti\-PD1/PD\-L1 treatment. Prior therapy with PD\-1/PDL\-1
- •inhibitors is allowed provided any toxicity attributed to prior PD\-1 or
- •PD\-L1\-directed therapy did not lead to discontinuation of therapy.
- •\* Phase II single agent part: advanced/metastatic solid tumors in the
- •indication in which signs of
- •anti\-tumor activity (CR, PR or durable SD with tumor shinkrage that does not
- •qualify for PR) were seen during phase I. Patients must have measurable
Exclusion Criteria
- •\* Symptomatic CNS metastases or CNS metastases that require local CNS\-directed
- •therapy or increasing doses of corticosteroids within the prior 2 weeks.
- •Patients with treated brain metastases should be neurologically stable
- •\* Out of range laboratory values.
- •\* Impaired cardiac function or clinically significant cardiac disease.
- •\* HBV or HCV positive patients, with active disease or whose hepatitis is not
- •controlled by therapy are excluded. HIV positive patients are excluded.
- •\* Active autoimmune disease or history of autoimmune disease
- •\* Any condition that requires systemic steroids
- •\* Systemic anti\-cancer therapy within 2\-4 weeks of the first dose of study
Investigators
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