drugset / Trial / NCT05275374

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

NCT05275374

Phase 1/2 Not yet recruiting 221 enrolled Xynomic Pharmaceuticals, Inc.
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2025-12-31
Primary completion
2027-12-30
Completion
2028-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Trametinib Small molecule 2 mg Oral
Subject XP-102 Small molecule Oral