A Study of Repotrectinib in Combination With Other Anticancer Therapies for the Treatment of Subjects With KRAS-Mutant Solid Tumors

Stopped early · Phase 1/Phase 2

Conditions studied: KRAS Mutation-Related Tumors, Metastatic Solid Tumor, Advanced Solid Tumor

In brief

A Phase 1b/2 Study of Repotrectinib in Combination with Other Anticancer Therapies for the Treatment of Subjects with KRAS-Mutant Advanced Solid Tumors (TRIDENT-2)

Key facts

Study ID

NCT05071183

Run by

Turning Point Therapeutics, Inc.

People needed

9

Starts

2021-09-23

Expected to finish

2023-03-01

Last updated by the study team

2024-04-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 (or as required by local regulation).
• Histological or cytological confirmation of unresectable or metastatic solid tumor malignancy harboring a KRAS mutation.
• No more than 3 prior standard treatments appropriate for tumor type and stage of disease.
• ECOG performance status ≤ 1.
• Existence of measurable disease (according to Response evaluation criteria in solid tumors [RECIST v1.1] criteria).
• Subjects with asymptomatic CNS metastases and/or asymptomatic leptomeningeal carcinomatosis are eligible.
• Adequate organ function.

You may not qualify if…

• Major surgery within four weeks of the start of treatment.
• Previous other cancer requiring treatment within the previous two years.
• Clinically significant cardiovascular disease.
• Any of the following cardiac criteria:
• Mean resting corrected QT interval (QTc) > 470 msec obtained from three ECGs and any factors that increase the risk of QTc prolongation or arrhythmic events
• Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG
• Known clinically significant active infections not controlled with systemic treatment (bacterial, fungal, viral including HIV positivity).
• Gastrointestinal disease or other malabsorption syndromes that would impact drug absorption.
• Subjects being treated with or anticipating the need for treatment with strong CYP3A inhibitors or inducers.

Where it is running

• Local Institution - 2101 — California City, California, United States
• Local Institution - 2109 — California City, California, United States
• Local Institution - 2106 — Denver, Colorado, United States
• Local Institution - 2108 — Nashville, Tennessee, United States
• Local Institution - 2107 — Houston, Texas, United States
• Local Institution - 2102 — Virginia Beach, Virginia, United States

Full record on ClinicalTrials.gov

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