Status:
NOT_YET_RECRUITING
XP-102 and XP-102 in Combination With Trametinib in Advanced Solid Tumor Patients With a BRAF V600 Mutation
Lead Sponsor:
Xynomic Pharmaceuticals, Inc.
Conditions:
Cancer
BRAF V600 Mutation
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 thyro...
Eligibility Criteria
Inclusion
- ≥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
- 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.
Key Trial Info
Start Date :
December 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2028
Estimated Enrollment :
221 Patients enrolled
Trial Details
Trial ID
NCT05275374
Start Date
December 31 2025
End Date
December 30 2028
Last Update
April 10 2025
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