Phase I-Ib/II Study of MBG453 as Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies

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

ClinicalTrials.gov Identifier: NCT02608268

Novartis Reference Number: CMBG453X2101

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The purpose of this first-in-human study of MBG453 is to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of MBG453 administered i.v. as a single agent or in combination with PDR001 or decitabine in adult patients with advanced solid tumors

Condition 
Advanced Malignancies
Phase 
Phase 1
Phase 2
Overall status 
Recruiting
Enrollment count 
267 participants
Start date 
Nov 23, 2015
Completion date 
Oct 15, 2021
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
MBG453
anti human TIM-3 monoclonal antibody
Drug
PDR001
anti-human PD-1 monoclonal antibody
Drug
Decitabine
commercially available chemotherapy

Eligibility Criteria

Inclusion Criteria:

Histologically documented advanced or metastatic solid tumors.
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 of standard therapy, or for whom no standard therapy exists and who did not receive prior anti-PD-1/PD-L1 treatment.
Phase II part (MBG453 single agent): Patients with advanced/metastatic solid tumors in the indication in which at least one confirmed PR or CR was 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.

Phase II part (MBG453 in combination 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)
Non small cell lung cancer (anti-PD-1/PD-L1 therapy naïve or pre-treated)
Renal Cell Carcinoma (anti-PD-1/PD-L1 therapy naïve or pre-treated)
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.
For MBG453 in combination with decitabine: anti-PD-1/PD-L1 therapy naïve SCLC patients who have failed no more than two lines of standard chemotherapy including topotecan

Exclusion Criteria:

Presence of symptomatic central nervous system metastases.
History of severe hypersensitivity reactions to other monoclonal antibodies.
Human Immunodeficiency Virus, Hepatitis B Virus or Hepatitis C Virus infection.
Active autoimmune disease or a documented history of autoimmune disease, including ulcerative colitis and Crohn's disease or any condition that requires systemic steroids.
Systemic steroid therapy or any immunosuppressive therapy (≥10mg/day prednisone or equivalent).
Use of any vaccines against infectious diseases (e.g. varicella, pneumococcus) within 4 weeks of initiation of study treatment.
Pre-treatment with anti-CTLA4 antibodies in combination with any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathway.
Participation in an interventional, investigational non-immunotherapy study within 2 weeks of the first dose of study treatment.
Prior participation in an interventional, investigational cancer vaccine or immunotherapy study except for an anti-PD-1/PD-L1 study.
For MBG453 in combination with decitabine: Hypersensitivity to decitabine or to any of the excipients, listed in decitabine country specific label

Other inclusion/exclusion criteria may apply.

Study Locations

United States
Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Med Sidney Kimmel CCC
Recruiting
Baltimore, 21231
Maryland
United States
Dana Farber Cancer Institute DFCI - Brookline
Recruiting
Boston, 02215
Massachusetts
United States
UT M.D Anderson Cancer Center
Recruiting
Houston, 77030
Texas
United States
Cancer Therapy and Research Center UT Health Science Center
Recruiting
San Antonio, 78229
Texas
United States
Canada
Novartis Investigative Site
Active, not recruiting
Toronto, M5G 2C1
Ontario
Canada
Italy
Novartis Investigative Site
Active, not recruiting
Milano, 20141
MI
Italy
Novartis Investigative Site
Completed
Rozzano, 20089
MI
Italy
Japan
Novartis Investigative Site
Completed
Kashiwa, 277 8577
Chiba
Japan
Korea, Republic of
Novartis Investigative Site
Completed
Seoul, 03080
-
Korea, Republic of
Netherlands
Novartis Investigative Site
Recruiting
Amsterdam, 1066 CX
-
Netherlands
Novartis Investigative Site
Recruiting
Leiden, 2300 RC
-
Netherlands
Singapore
Novartis Investigative Site
Active, not recruiting
Singapore, 169610
-
Singapore
Switzerland
Novartis Investigative Site
Recruiting
Geneve 14, CH 1211
-
Switzerland
Taiwan
Novartis Investigative Site
Recruiting
Taipei, 10002
-
Taiwan

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]