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Trident-1

A Study of TPX-0005 (Repotrectinib) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements

Turning Point Therapeutics is enrolling patients in a Phase 1/2 trial called TRIDENT-1. The multi-center trial is evaluating our lead drug candidate, repotrectinib, for the treatment of patients with ROS1+ advanced non-small-cell lung cancer (NSCLC) as well as patients with ROS1+, NTRK+ or ALK+ advanced solid tumors.

Tumors with mutations to their ROS1, NTRK and ALK genes have a higher likelihood of developing resistance to existing targeted therapies. In many cases, these mutations prevent existing medicine from targeting and binding to the tumor as effectively as tumors that don’t carry the mutations. Repotrectinib is designed to be smaller and less bulky than existing targeted therapies, and may circumvent some the resistance mechanisms found in tumors with ROS1, NTRK and ALK mutations.

Repotrectinib is being assessed for safety, tolerability, pharmacokinetics and antitumor activity.

*For a complete list of inclusion and exclusion criteria, visit www.clinicaltrials.gov

Key Inclusion Criteria

  1. Confirmed diagnosis of locally advanced or metastatic solid tumor that harbors an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement
  2. ECOG Performance Status score of 0-1
  3. Age ≥18 (or age ≥ 20 of age as required by local regulation)

Key Exclusion Criteria

  1. Concurrent participation in another therapeutic clinical trial
  2. Symptomatic CNS involvement
  3. History of certain cardiovascular symptoms/events in the past 6 months

Where are the trials located?

Patients can enroll at study locations in the U.S. and Korea. For more information, contact us at clinical@tptherapeutics.com.

Precision Oncology

The TRIDENT-1 study will be using new genetic tests to determine whether tumor cells carry the genetic mutations of interest: ROS1, NTRK, ALK. These genetic tests help identify patients with tumors that are most likely to respond to treatment. It’s important to know that not all patients will be eligible for clinical trials. Additional criteria will also be used to determine eligibility.

Patients can enroll at study locations in the U.S. and Korea. For more information, contact us at clinical@tptherapeutics.com.

UNITED STATES

California

UC Irvine Health, Chao Family Comprehensive Cancer Center
Orange, California
Contact: Susanna Searcy, 877-827-8839, ucstudy@uci.edu

Colorado

University of Colorado, Denver
Aurora, Colorado
Contact: Paula Fisk, 720-848-0676, paula.fisk@ucdenver.edu

Massachusetts

Massachusetts General Hospital
Boston, Massachusetts
Contact: Alice T Shaw, M.D., Ph.D., 617-724-4000, ashaw1@partners.org

New York

Memorial Sloan Kettering Cancer Center
New York, New York
Contact: Deepa Ramaswami, 646-888-4425, ramaswad@mskcc.org or Judy Nguyen, (646) 888-4425, Nguyenj2@mskcc.org

REPUBLIC OF KOREA

Seoul

Seoul National University Hospital
Seoul, Republic of Korea
Contact: Dong-Wan Kim, M.D., Ph.D., +82-2-2072-2995, kimdw@snu.ac.kr

Yonsei Cancer Center, Severance Hospital
Seoul, Republic of Korea
Contact: Byoung Chul Cho, M.D., Ph.D., +82-2-2228-8126, cbc1971@yuhs.ac

Samsung Medical Center
Seoul, Republic of Korea
Contact: Jeeyun Lee, M.D., Ph.D., +82-2-3410-3459, jyun.lee@samsung.com

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