Clinical Trials/NCT05275374

NCT05275374

Not yet recruiting

Phase 1

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)

Xynomic Pharmaceuticals, Inc.0 sites221 target enrollmentDecember 31, 2025

ConditionsCancer BRAF V600 Mutation Melanoma Colorectal Cancer Thyroid Cancer Nonsmall Cell Lung Cancer

InterventionsXP-102 Trametinib

DrugsXP-102 Trametinib

Overview

Phase: Phase 1
Intervention: XP-102
Conditions: Cancer
Sponsor: Xynomic Pharmaceuticals, Inc.
Enrollment: 221
Primary Endpoint: Characterize the safety of XP-102.
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

December 31, 2025

End Date

December 30, 2028

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Xynomic Pharmaceuticals, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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).
•Must have failed conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options. Prior treatment with BRAF inhibitors and/or MEK inhibitors is permitted；
•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;

Exclusion Criteria

•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.
•Patients who have persistent toxicity caused by previous chemotherapeutic drugs or radiotherapy has not recovered to lower than grade 2 (except hair loss) according to CTCAE version 5.0;
•Patients who are allergic to active substances or excipients of XP-102 or trametinib.
•Significant traumatic injury within 28 days before the first dose of the investigational drug, or if major surgery is anticipated during the course of study treatment;
•According to the judgment of the investigator, patients with dysphagia, or any gastrointestinal diseases that may affect drug absorption or activity;
•Administration of strong inhibitors or inducers of CYP3A4 liver metabolic enzymes within 14 days before the first dose of the investigational drug;
•Patients who are receiving drugs that may prolong QT interval and unable or unwilling to stop treatment or switch to other alternative treatment before study enrollment;
•Symptomatic active fungal, bacterial and/or viral infections; including known HIV, active hepatitis B, active hepatitis C or active syphilis infection.
•Any poorly controlled disorders (such as serious mental, neurological, cardiovascular, respiratory, digestive, urinary, bleeding and coagulation, or other system diseases) that may significantly affect the clinical trial;

Arms & Interventions

Part 1 - XP-102 Dose Escalation

XP-102

Intervention: XP-102

Part 2 - XP-102 + Trametinib Dose Escalation

XP-102 plus Trametinib

Intervention: XP-102

Part 2 - XP-102 + Trametinib Dose Escalation

XP-102 plus Trametinib

Intervention: Trametinib

Part 3 - XP-102 + Trametinib Dose Expansion

XP-102 plus Trametinib

Intervention: XP-102

Part 3 - XP-102 + Trametinib Dose Expansion

XP-102 plus Trametinib

Intervention: Trametinib

Outcomes

Primary Outcomes

Characterize the safety of XP-102.

Time Frame: 28 days

Number of participants with treatment related adverse events.

Evaluate the pharmacokinetics of XP-102.

Time Frame: 28 days

Blood plasma concentration.

Establish maximum tolerated dose of XP-102.

Time Frame: 28 days

Number of participants with dose limiting toxicity

Secondary Outcomes

Evaluate clinical activity/efficacy of XP-102.(Approximately every 8 weeks (up to 2 years))
Evaluate the pharmacokinetics of XP-102 + trametinib.(28 days)
Characterize tolerability of XP-102 in combination with trametinib.(28 days)
Evaluate the pharmacokinetics of XP-102 administered with food(4 days)