XP-102 and XP-102 in Combination With Trametinib in Advanced Solid Tumor Patients With a BRAF V60… (NCT05275374) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
XP-102 and XP-102 in Combination With Trametinib in Advanced Solid Tumor Patients With a BRAF V600 Mutation
221 participantsStarted 2025-12-31
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 permittedï¼›
* 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 progr…