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NOT YET RECRUITING
NCT05275374
PHASE1/PHASE2

XP-102 and XP-102 in Combination With Trametinib in Advanced Solid Tumor Patients With a BRAF V600 Mutation

Sponsor: Xynomic Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

This is a first-in-human multi-center study which will be conducted in advanced malignant solid tumors patients. The solid tumor type is limited to melanoma, colorectal, non-small-cell lung, and thyroid cancer with positive BRAF V600 mutation. This study is divided into three stages: Phase Ia: a dose-escalation phase of XP-102; Phase Ib: a dose-escalation and sample size expansion phase of XP-102 plus trametinib; Phase IIa: an expansion phase of XP-102 plus trametinib.

Official title: A Dose-escalation and Expansion Phase I/IIa Study of XP-102 and XP-102 in Combination With Trametinib in Advanced Solid Tumor Patients With a BRAF V600 Mutation (ENHANCE)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

221

Start Date

2025-12-31

Completion Date

2028-12-30

Last Updated

2025-04-10

Healthy Volunteers

No

Interventions

DRUG

XP-102

XP-102 will be administered orally once or twice daily in a continuous regimen.

DRUG

Trametinib

Trametinib will be administered 2mg orally once a day.