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NCT05275374 | NOT YET RECRUITING | Cancer

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

Xynomic Pharmaceuticals, Inc.

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.

Condition or disease

Cancer

BRAF V600 Mutation

Melanoma

Colorectal Cancer

Thyroid Cancer

Nonsmall Cell Lung Cancer

Intervention/treatment

XP-102

Trametinib

Phase

PHASE1

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 221 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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)
Actual Study Start Date : 2024-12
Estimated Primary Completion Date : 2025-12
Estimated Study Completion Date : 2026-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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;
  • * Patients must understand and voluntarily sign the written informed consent form, before the initiation of any study-specific procedures in the trial.
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;
  • * Other situations not suitable for participation in the study as judged by the investigator.
XP-102 and XP-102 in Combination With Trametinib in Advanced Solid Tumor Patients With a BRAF V600 Mutation

Location Details

NCT05275374

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