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

• Status: Recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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)

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Turning Point Therapeutics, Inc.
• Treatments: Trametinib

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.