EUCTR2015-002354-12-NL
Active, not recruiting
Phase 1
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
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- ovartis Pharma Services AG
- Enrollment
- 252
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1\. Histologically documented advanced or metastatic solid tumors.
- •2\. Phase I\-Ib part (including dose ranging part): Patients with advanced/metastatic solid tumors, with measurable or non measurable disease as determined by RECIST v1\.1, who have progressed despite standard therapy or are intolerant to standard therapy, or for whom no standard therapy exists.
- •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 and after discussion between the Investigator and Novartis study medical representative.
- •3\. Phase II part (MBG453 single agent): Patients with 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 the dose escalation phase I part. Patients must have measurable disease as determined by RECIST v1\.1, have progressed despite standard therapy or be intolerant to standard therapy.
- •4\. Phase II part (MBG453 in combination with PDR001\): Patients with advanced/metastatic tumors in the below selected indications, with at least one measurable lesion as determined by RECIST v1\.1, who have received standard therapy and are intolerant of standard therapy or have progressed following their last prior therapy.:
- •Melanoma (anti\-PD\-1/PD\-L1 therapy naïve or pre\-treated)
- •NSCLC (anti\-PD\-1/PD\-L1 therapy naïve or pre\-treated)
- •RCC (anti\-PD\-1/PD\-L1 therapy naïve or pre\-treated)
- •5\. Must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution's guidelines. Patient must be willing to undergo a new tumor biopsy at screening/baseline, and during therapy on the study.
- •6\. For MBG453 in combination with decitabine (phase Ib/II): anti\-PD\-1/PD\-L1 therapy naïve SCLC patients who have failed no more than two lines of standard chemotherapy including topotecan.
Exclusion Criteria
- •1\. Presence of symptomatic central nervous system (CNS) metastases.
- •2\. History of severe hypersensitivity reactions to any ingredients of
- •study drugs and other monoclonal
- •antibodies (mAbs) and/or their excipients.
- •3\. HBV or HCV positive patients, with active disease or whose hepatitis is
- •not controlled by therapy are excluded.
- •HIV positive patients are excluded.
- •4\. Active autoimmune disease or a documented history of autoimmune
- •disease, including ulcerative colitis and Crohn's disease or any condition
- •that requires systemic steroids.
Investigators
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