A Phase 1 Study of TSR-022, an Anti-TIM-3 Monoclonal Antibody, in Patients With Advanced Solid Tumors (AMBER)

  • Interventional
  • Recruiting
  • NCT02817633
Eligibility Details Visit Clinicaltrials.gov

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)

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.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

Partial Inclusion Criteria:

         - Patient with advanced or metastatic solid tumor and has disease progression or treatment intolerance after treatment with available therapies

         - Agreement to biopsies before and during treatment, depending on study part

         - Female patients must have a negative pregnancy test or be of non-childbearing potential.

         - Required that female patients of childbearing potential use two methods of contraception with their partner

         - Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 with adequate hematologic and organ function

        Partial Exclusion Criteria:

         - Received prior therapy with an anti-CTLA-4, anti-PD-1, anti-PD1-ligand-1 (anti-PD-L1) or anti-PD-1 ligand-2 (anti-PD-L2) agent within 3 weeks prior to initiation of study treatment depending on study part

         - Prior treatment with an anti-PD-1, anti-PD-L1, anti-TIM-3 or anti-LAG-3 (Part 1e)

         - Prior treatment with an anti-LAG-3 or anti-TIM-3 (Part 2)

         - Known uncontrolled central nervous system (CNS) metastases and/or carcinomatous meningitis or known malignancy that progressed or required active treatment within the last 2 years

         - Pregnant, breastfeeding, or expecting to conceive children within 150 days after the last dose of study treatment

         - History of human immunodeficiency virus (HIV), pneumonitis, active Hepatitis B or Hepatitis C, or ≥Grade 3 immune-related AE with prior immunotherapy

         - Autoimmune disease that required systemic treatment

         - Not recovered from radiation and chemotherapy-induced AEs

         - Participated in another investigational study (drug or device) within 4 weeks of first dose

         - Received prior anticancer therapy within 21 days of first dose

         - Not recovered from AEs and/or complications from major surgery prior to first dose

         - Received a vaccine within 7 days of first dose
  • Solid Tumors

At a Glance

National Government IDNCT02817633

IRB#IRB16-0640

Lead SponsorTesaro, Inc.

Lead PhysicianHedy Kindler

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting