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

Sponsor
Xynomic Pharmaceuticals, Inc.
Study ID
NCT05275374
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • XP-102 — DRUG
    XP-102 will be administered orally once or twice daily in a continuous regimen.
  • Trametinib — DRUG
    Trametinib will be administered 2mg orally once a day.

Study Details

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.

Key Dates

Start date
Dec 31, 2025
Status verified
Apr 2025
Primary completion
Dec 30, 2027
Completion
Dec 30, 2028

Study Design

Enrollment
221 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 - XP-102 Dose Escalation
    XP-102
  • Experimental: Part 2 - XP-102 + Trametinib Dose Escalation
    XP-102 plus Trametinib
  • Experimental: Part 3 - XP-102 + Trametinib Dose Expansion
    XP-102 plus Trametinib

Primary Outcome Measure

Characterize the safety of XP-102. [ Time Frame: 28 days ]

Central Contacts

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