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

X

Xynomic Pharmaceuticals

Status and phase

Begins enrollment in 7 months
Phase 2
Phase 1

Conditions

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

Treatments

Drug: XP-102
Drug: Trametinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT05275374
XYN-701

Details and patient eligibility

About

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.

Enrollment

221 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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).
  • 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

221 participants in 3 patient groups

Part 1 - XP-102 Dose Escalation
Experimental group
Description:
XP-102
Treatment:
Drug: XP-102
Part 2 - XP-102 + Trametinib Dose Escalation
Experimental group
Description:
XP-102 plus Trametinib
Treatment:
Drug: Trametinib
Drug: XP-102
Part 3 - XP-102 + Trametinib Dose Expansion
Experimental group
Description:
XP-102 plus Trametinib
Treatment:
Drug: Trametinib
Drug: XP-102

Trial contacts and locations

0

Loading...

Central trial contact

Sophia Paspal, Ph.D.

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems