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.
≥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);
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.
Sequential
XP-102
DrugXP-102 will be administered orally once or twice daily in a continuous regimen.
Trametinib
DrugTrametinib will be administered 2mg orally once a day.
Characterize the safety of XP-102.
Number of participants with treatment related adverse events.
Evaluate the pharmacokinetics of XP-102.
Blood plasma concentration.
Establish maximum tolerated dose of XP-102.
Number of participants with dose limiting toxicity
Evaluate the pharmacokinetics of XP-102 + trametinib.
Blood plasma concentration.
Characterize tolerability of XP-102 in combination with trametinib.
Number of participants with dose limiting toxicity
Evaluate the pharmacokinetics of XP-102 administered with food
Blood plasma concentration.
Evaluate clinical activity/efficacy of XP-102.
Overall Response Rate with RECIST criteria v1.1.
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This trial is not recruiting at the moment. You can still explore other options:
