OncoMatch/Clinical Trials/NCT03093116
A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements
Is NCT03093116 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Oral repotrectinib (TPX-0005) for locally advanced solid tumors.
Treatment: Oral repotrectinib (TPX-0005) — Phase 1 dose escalation will determine the first cycle dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD), the biologically effective dose and recommended Phase 2 dose (RP2D) of repotrectinib given to adult subjects with advanced solid malignancies harboring an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. Midazolam DDI substudy will examine effect of of repotrectinib on CYP3A induction. Phase 2 will determine the confirmed Overall Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) of repotrectinib in each subject population expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. The secondary objective will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS) and clinical benefit rate (CBR) of repotrectinib in each expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Biomarker criteria
Required: ALK rearrangement
harbors an ALK...gene rearrangement by protocol specified tests
Required: ROS1 rearrangement
harbors a ROS1...gene rearrangement by protocol specified tests
Required: NTRK1 rearrangement
harbors a NTRK1...gene rearrangement by protocol specified tests
Required: NTRK2 rearrangement
harbors a NTRK2...gene rearrangement by protocol specified tests
Required: NTRK3 rearrangement
harbors a NTRK3...gene rearrangement by protocol specified tests
Disease stage
Required: Stage IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Lab requirements
Blood counts
ANC ≥1500/mm3 (1.5 × 10^9/L); Platelets ≥100,000/mm3 (100 × 10^9/L); Hemoglobin ≥ 9.0 g/dL (transfusions allowed)
Kidney function
Serum creatinine or creatinine clearance within normal limits or > 40 mL/min
Liver function
Total serum bilirubin < 1.5 × ULN; Liver transaminases (ASTs/ALTs) < 2.5 × ULN; < 5 × ULN if liver metastases are present; Alkaline phosphatase (ALP) < 2.5 × ULN; < 5 × ULN if liver and/or bone metastasis are present
Cardiac function
Mean resting QTcF > 470 msec (exclusion); clinically significant cardiovascular disease (active or within 6 months); ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2; any clinically important abnormalities in rhythm, conduction or morphology of resting ECG
Baseline laboratory values fulfilling the following requirements: ANC ≥1500/mm3; Platelets ≥100,000/mm3; Hemoglobin ≥ 9.0 g/dL; Serum creatinine or creatinine clearance > 40 mL/min; Total serum bilirubin < 1.5 × ULN; Liver transaminases (ASTs/ALTs) < 2.5 × ULN; < 5 × ULN if liver metastases are present; Alkaline phosphatase (ALP) < 2.5 × ULN; < 5 × ULN if liver and/or bone metastasis are present; Serum calcium, magnesium, and potassium normal or CTCAE grade ≤ 1 with or without supplementation. Cardiac exclusion: Mean resting QTcF > 470 msec; clinically significant cardiovascular disease; ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2; any clinically important abnormalities in rhythm, conduction or morphology of resting ECG.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Local Institution - 2129 · Duarte, California
- Local Institution - 2120 · Glendale, California
- Local Institution - 2136 · La Jolla, California
- Local Institution - 2114 · La Jolla, California
- Local Institution - 2121 · Long Beach, California
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