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A Study of Repotrectinib in Combination With Other Anticancer Therapies for the Treatment of Subjects With KRAS-Mutant Solid Tumors | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

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

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)

NCT05071183•Turning Point Therapeutics, Inc.

View on ClinicalTrials.gov

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)

Detailed Description

Phase 1 Dose Escalation: To evaluate tolerability of repotrectinib at increasing dose levels in combination with other anticancer therapies for the treatment of subjects with locally advanced or metastatic KRAS-mutant solid tumors Phase 2 Efficacy Evaluation: Investigate the anti-tumor efficacy and safety of repotrectinib in combination with other anticancer therapies for the treatment of patients with locally advanced or metastatic KRAS-mutant solid tumors.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (6)

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

Key Dates

Start Date

September 23, 2021

Primary Completion Date

March 1, 2023

Completion Date

March 1, 2023

Last Updated

April 2, 2024

Enrollment

ACTUAL participants

Conditions

KRAS Mutation-Related TumorsMetastatic Solid TumorAdvanced Solid Tumor

Interventions

TPX-0005

DRUG

Trametinib

DRUG

A Study of PYX-201 in Advanced Solid Tumors

NCT05720117

Solid TumorAdvanced Solid Tumor

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RECRUITINGPHASE1/PHASE2

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

NCT06898450

Advanced Solid Tumors CancerMSI-H Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 2, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of PYX-201 in Advanced Solid Tumors

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