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

Launched by XYNOMIC PHARMACEUTICALS, INC. · Mar 1, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment called XP-102, both on its own and in combination with another drug called trametinib, for patients with advanced cancers that have a specific genetic change known as the BRAF V600 mutation. The types of cancer being studied include melanoma, colorectal cancer, non-small cell lung cancer, and thyroid cancer. The trial is in its early stages, meaning researchers are testing different doses of these drugs to see how well they work and to understand their safety.

To be eligible for this trial, participants need to be at least 18 years old and have one of the specified types of cancer with the BRAF V600 mutation. They should have already tried other treatments that didn't work or have no other proven options available. Patients will need to have a measurable tumor and meet certain health criteria to ensure they can safely participate. If you choose to take part in this study, you'll have regular visits for check-ups and tests, and you'll need to agree to follow the study guidelines. It's important to know that the trial is not yet recruiting participants, so it will be some time before anyone can enroll.

Gender

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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;
• • 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.