Status:
TERMINATED
First-in-Human Study of MS201408-0005A as Single Agent and in Combinations
Lead Sponsor:
EMD Serono Research & Development Institute, Inc.
Collaborating Sponsors:
Merck KGaA, Darmstadt, Germany
Conditions:
Metastatic or Locally Advanced Unresectable Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a Phase I, open-label study to determine the safety, tolerability, pharmacokinetic (PK), pharmacodynamics (PD), and preliminary antitumor activity of MS201408-0005A as single agent (Part IA on...
Eligibility Criteria
Inclusion
- Subjects with histologically or cytologically proven advanced or metastatic solid malignancies for whom no effective standard therapy exists or has failed or subjects who are intolerant to established therapy known to provide clinical benefit for their condition (dose escalation cohorts; Part I).
- An eastern cooperative oncology group performance status (ECOG PS) of 0 to 1 at screening and adequate hematological, renal and hepatic function as defined by protocol specified criteria.
- Other protocol defined inclusion criteria could apply.
Exclusion
- Intolerance to immune checkpoint inhibitor therapy as defined by the occurrence of an adverse drug reaction requiring drug discontinuation (dose escalation cohorts), concurrent anticancer treatment or immunosuppressive agents.
- Prior organ transplantation including allogeneic stem cell transplantation, brain metastases (except those meeting certain protocol specified criteria which are acceptable), significant acute or chronic infections, a history of cardiovascular/cerebrovascular disease.
- Current significant cardiac conduction abnormalities and hypokalemia as specified in the protocol.
- Warfarin or other Vitamin K antagonists treatment, strong inhibitors or inducers of cytochrome P450 (CYP)3A4, and drugs with a narrow therapeutic index, which are predominantly metabolized by CYP3A4 and drugs known to have a high risk to prolong QTc as per label.
- Pregnancy or lactation.
- Severe hypersensitivity reactions to monoclonal antibodies, known hypersensitivity to the investigational medicinal products or to one or more of the excipients, autoimmune diseases (inflammatory bowel diseases, interstitial lung disease, or pulmonary fibrosis), and live vaccines within 28 days prior to study entry.
- Pneumonitis and history of pneumonitis.
- Other protocol defined exclusion criteria could apply.
Key Trial Info
Start Date :
October 3 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 14 2019
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03306420
Start Date
October 3 2017
End Date
January 14 2019
Last Update
February 6 2020
Active Locations (3)
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1
Yale Cancer Center
New Haven, Connecticut, United States, 06510
2
University of TX M.D. Anderson Cancer Center-Investigational Cancer Therapeutics Partner
Houston, Texas, United States, 77030
3
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, United States, 78229