Trials / Not Yet Recruiting
Not Yet RecruitingNCT05275374
XP-102 and XP-102 in Combination With Trametinib in Advanced Solid Tumor Patients With a BRAF V600 Mutation
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)
- Status
- Not Yet Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 221 (estimated)
- Sponsor
- Xynomic Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-12-31
- Primary completion
- 2027-12-30
- Completion
- 2028-12-30
- First posted
- 2022-03-11
- Last updated
- 2025-04-10
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05275374. Inclusion in this directory is not an endorsement.