NCT05071183

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)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Turning Point Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• KRAS Mutation-Related Tumors
• Metastatic Solid Tumor
• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	TPX-0005	Oral TPX-0005 capsules
DRUG	Trametinib	Oral trametinib tablets

Timeline

• Start date: 2021-09-23
• Primary completion: 2023-03-01
• Completion: 2023-03-01
• First posted: 2021-10-08
• Last updated: 2024-04-02
• Results posted: 2024-04-02

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study