Status: Active Trial | Marker: NTRK, ROS1

Title

A Phase 1/2, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients with Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements (TRIDENT-1)

Study Number

NCT03093116

Indication

Histologically confirmed locally advanced/metastatic (stage IIIB or IV per AJCC/IASLC v. 8) NSCLC as first-line setting.

Primary Objective

To determine the confirmed ORR as assessed by BICR of repotrectinib in each subject population expansion cohort of solid tumors that harbor an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.

In- and exclusion Criteria

Inclusion Criteria
• Histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumor (including primary CNS tumors; Stage IV, American Joint Committee on Cancer v.7) that harbors an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement
• Prior cytotoxic chemotherapy for advanced or metastatic disease is allowed. At the time of starting treatment with repotrectinib, at least 14 days or 5 half-lives (whichever is shorter) must have elapsed after discontinuation of prior cytotoxic chemotherapy (or at least 42 days for prior nitrosoureas, mitomycin C, and liposomal doxorubicin) and all side effects from prior treatments must have resolved to grade ≤ 1 (CTCAE Version 4.03) with the exception of alopecia

Study Design

Phase II, multicentric

Responsibilities

Turning Point Therapeutics, Inc.
10628 Science Center Dr., #200
San Diego, CA 92121

Trial Centre

University Hospital of Cologne
Dep. I of Internal Medicine
Phone: +49 221 478 87008
Fax: +49 221 478 87010
lungenkrebs@uk-koeln.de

Principal investigator

Prof. Dr. Jürgen Wolf

Letzte Änderung: 26. August 2020