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XP-102 and XP-102 in Combination With Trametinib in Advanced Solid Tumor Patients With a BRAF V600 Mutation | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE1/PHASE2

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)

NCT05275374•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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•≥18 years of age
•Advanced malignant solid tumor patients with a BRAF V600 mutation (limited to melanoma, colorectal cancer, non-small cell lung cancer, or thyroid cancer).

Exclusion Criteria

•At least one measurable lesion (brain metastasis must not be the only measurable lesion) according to Response Evaluation Criteria in Solid Tumours (RECIST v1.1);
•ECOG performance status of 0 or 1;
•Expected survival ≥ 3 months;
•Adequate liver, renal, coagulation, cardiac, and hematologic function.
•A negative pregnancy test if female patient is of reproductive potential.
•For men and women of reproductive potential, agreement to use an effective contraceptive method from the time of screening and throughout their time on study.
•Patients must agree to, and be capable of, adhering to the study visit schedule and all other protocol requirements;
•Patients must understand and voluntarily sign the written informed consent form, before the initiation of any study-specific procedures in the trial.
•Active central nervous system (CNS) lesions. However, patients with asymptomatic and brain metastases who received treatment (including targeted brain radiotherapy, surgical treatment, glucocorticoid or other treatments) without disease progression for ≥ 3 months are eligible.
•Patients who received radiotherapy, immunotherapy, hormone therapy, targeted therapy, biotherapy, traditional Chinese medicine therapy, chemotherapy or any clinical trial treatment within 14 days before the first dose.
+9 more criteria

Key Dates

Start Date

December 31, 2025

Primary Completion Date

December 30, 2027

Completion Date

December 30, 2028

Last Updated

April 10, 2025

Enrollment

221

ESTIMATED participants

Conditions

CancerBRAF V600 MutationMelanomaColorectal CancerThyroid CancerNonsmall Cell Lung Cancer

Interventions

XP-102

DRUG

Trametinib

DRUG

Contacts

Sophia Paspal, Ph.D.

CONTACT

610-405-5974 Sophia.paspal@xynomicpharma.com

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

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