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

Study acronym: ENHANCE
StatusNot Yet Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 2025 to Dec 30, 2027 Start date: Dec 2024 to Dec 31, 2025 · Completion date: Dec 2026 to Dec 30, 2028v6 Show 2 more changesShow less
    • Start date: Dec 2024 to Dec 31, 2025
    • Completion date: Dec 2026 to Dec 30, 2028
  2. Primary completion date: Dec 2024 to Dec 2025 Start date: Dec 2023 to Dec 2024v5 Show 1 more changeShow less
    • Start date: Dec 2023 to Dec 2024
  3. Start date: Dec 2022 to Dec 2023v4
  4. Start date: Jun 2022 to Dec 2022v3
  5. Study title shortened, about 5 wordsv2 See this version in full on ClinicalTrials.gov ↗
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05275374
Lead Sponsor Xynomic Pharmaceuticals, Inc.
Conditions Cancer, BRAF V600 Mutation, Melanoma, Colorectal Cancer, Thyroid Cancer, Nonsmall Cell Lung Cancer
Enrollment 221 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov