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

Overview

About this study

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 who have limited available treatment options. The study will be conducted in 2 parts: dose escalation and cohort expansion.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Female patients must have a negative serum or urine pregnancy test within 72 hours prior to the date of the first dose of study medication if of childbearing potential or be of nonchildbearing potential.
  • Female patients of childbearing potential (see above) must agree to use 2 adequate methods of contraception with their partner.
  • ECOG performance status of ≤1.
  • Adequate hematologic and organ function.

Exclusion Criteria:

  • For Part 1a: anti-CTLA-4, anti-PD-1, anti-PD-1-ligand-1 (anti-PD-L1), or anti-PD-1 ligand-2 (anti-PD-L2) agent within 3 weeks (ie, 21 days) prior to initiation of study treatment.
  • For Parts 1b,1c and 1d: anti-CTLA-4 within 3 weeks (i.e., 21 days) prior to initiation of study treatment and/or prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-TIM-3 or anti-LAG-3 agent that resulted in permanent discontinuation due to an AE.
  • For Part 1e: prior treatment with anti-PD-1, anti-PD-L1, anti-TIM-3 or anti-LAG-3.
  • For Part 2 combination arm/s (TSR-022 + TSR-042): prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agent that resulted in permanent discontinuation due to an AE; prior treatment with an anti LAG-3 or anti TIM-3 is also excluded
  • Known uncontrolled central nervous system (CNS) metastases and/or carcinomatousmeningitis.
  • Other serious, uncontrolled medical disorders including, but not limited to nonmalignant systemic disease or active infection requiring systemic therapy, immunodeficiency, known history of human immunodeficiency virus (HIV) infection or HIV 1/2 antibodies, known active hepatitis B, active autoimmune disease, history of interstitial lung disease, history of ≥Grade 3immune-related AE with prior immunotherapy with the exception of non-clinically significant lab abnormalities.
  • History of pneumonitis.
  • History of ≥Grade 3 immune-related AE with prior immunotherapy with the exception of non-clinically significant lab abnormalities.
    • Note (for all patients except Part 1e):
      • Patient may be considered eligible if anti PD-1/PD-L1 antibody treatment was tolerated without corticosteroids or other immunosuppressive therapy following a Grade 3 irAE on prior anti-CTLA-4 therapy.
  • Pregnant or breast feeding, or expecting to conceive children within the projected duration of the study.
  • Not recovered (i.e., to ≤ Grade 1 or to baseline) from treatment-related AEs.
  • Participation in an investigational study (therapy or device) within 4 weeks prior to start of study treatment.
  • Prior anticancer therapy within 21 days, or less than 5 times the half-life of the most recent therapy prior to study Day 1, whichever is shorter.
  • Incomplete recovery from AEs and/or major surgery (must be (≤ Grade 1).
  • Received a vaccine within 7 days of planned start of study therapy.
  • Has a known hypersensitivity to TSR-022, TSR-042, TSR-033 or to nivolumab (if applicable) components or excipients.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Alex Adjei, M.D., Ph.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mahesh Seetharam, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Yanyan Lou, M.D., Ph.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions