Protocol #: 17-607
Status
Recruiting
Description
This is a multicenter, open-label, first-in-human Phase 1 study evaluating the anti-TIM-3 (T cell immunoglobulin and mucin containing protein-3) antibody TSR-022, as a monotherapy and in combination with an anti-PD-1 antibody, in patients with advanced solid tumors. The study will be conducted in 2 parts: dose escalation and cohort expansion.
Condition
Advanced or Metastatic Solid Tumors
Interventions
TSR-022
TSR-042, an anti-PD-1 antibody
TSR-033, an anti-LAG-3 antibody
Phase
Phase 1
Study Type
Interventional
Further Study Details
Primary Outcome:
Safety and tolerability of TSR-022 using Common Terminology Criteria for Adverse Events (CTCAE v.4.03) in patients with advanced solid tumors
Anti-tumor activity of TSR-022 in patients with solid tumors, in terms of objective response rate (ORR) as assessed by the Investigators using Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1
Recommended Phase 2 dose (RP2D) and schedule as monotherapy and in combination therapy
Secondary Outcome:
Safety and tolerability of TSR-022 using CTCAE v.4.03
Overall Response Rate (ORR) by RECIST v. 1.1 (Part 1)
ORR by immune-related RECIST (irRECIST)
Duration of response (DOR) by RECIST v 1.1
Disease control rate (DCR) by RECIST v 1.1 and by irRECIST
Progression-free survival (PFS) by RECIST v 1.1 and by irRECIST
Overall survival (OS)
Immunogenicity as assessed by the presence of anti-drug antibodies
Maximum plasma concentration (Cmax) of TSR-022
Minimum plasma concentration (Cmin) of TSR-022
Area under the curve (AUC),0-infinity of TSR-022
Area under the curve at steady state (AUC,ss) of TSR-022
Maximum plasma concentration at steady state (Cmax,ss) of TSR-022
Minimum plasma concentration at steady state (Cmin,ss) of TSR-022
Maximum plasma concentration (Cmax) of TSR-042
Minimum plasma concentration (Cmin) of TSR-042
Area under the curve (AUC),0-infinity of TSR-042
Area under the curve at steady state (AUC,ss) of TSR-042
Maximum plasma concentration at steady state (Cmax,ss) of TSR-042
Minimum plasma concentration at steady state (Cmin,ss) of TSR-042
Maximum plasma concentration (Cmax) of TSR-033
Minimum plasma concentration (Cmin) of TSR-033
Area under the curve (AUC),0-infinity of TSR-033
Area under the curve at steady state (AUC,ss) of TSR-033
Maximum plasma concentration at steady state (Cmax,ss) of TSR-033
Minimum plasma concentration at steady state (Cmin,ss) of TSR-033
Maximum plasma concentration (Cmax) of nivolumab
Minimum plasma concentration (Cmin) of nivolumab
Area under the curve (AUC),0-infinity of nivolumab
Area under the curve at steady state (AUC,ss) of nivolumab
Maximum plasma concentration at steady state (Cmax,ss) of nivolumab
Minimum plasma concentration at steady state (Cmin,ss) of nivolumab
Estimated Enrollment
819
Study Start Date
July 2016
Eligibility
Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Health Volunteers: No
Criteria
Tesaro, Inc.
Information Provided By
Tesaro, Inc.
Official Title
A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-022, an Anti-TIM-3 Monoclonal Antibody, in Patients With Advanced Solid Tumors (AMBER)
Clinicaltrials.gov Identifier
NCT02817633

 

 

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.

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