Status and phase
Conditions
Treatments
About
This is a phase I clinical study of WBC100 in Patients with advanced solid tumor.
Full description
This is a phase I open-label, single and dose escalation study to evaluate the safety, cell pharmacokinetics, and preliminary efficacy of WBC100, a drug targeting c-myc, in subjects who have been diagnosed with c-myc positive advanced solid tumor and refractory or intolerant to current standard systemic treatment.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Sign informed consent, able to follow protocol requirements
Aged 18 to 75 years, male or female
Dose escalation stage: Histopathology or cytology proven advanced solid tumor with positive C-myc who have developed progressive disease or intolerability after at least one line of standard systemic therapies Dose expansion stage: Histopathology or cytology proven advanced pancreatic cancer with positive C-myc who are not suitable for surgery or local treatment, have developed progressive disease or intolerability after at least one line of standard systemic therapies Positive C-myc refer to C-myc overexpression: more than 10% tumor cells are detected 1+ by immunohistochemistry (IHC)
ECOG Performance Status score: 0 to 2 points
Expected survival is > 3 months
Adequate hematologic and organ functions (without persistent supportive treatment)
f. Left ventricular ejection fraction (LVEF) ≥ 50%. Heart rate (HR) ≥ 60 bpm. QT intervals, male ≤ 450 ms, female ≤ 470 ms
According to RECIST 1.1, patients have at least one evaluable target lesion(only for dose expansion stage)
Female patients of child-bearing potential or male subjects whose spouses are women of childbearing potential must agree to use a reliable method of contraception (IUD, oral contraceptive, condom) throughout the treatment period and for 3 months after discontinuation of WBC100. Female patients of child-bearing age must undergo a serum pregnancy test before the initiation of the study and the result must be negative.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
60 participants in 1 patient group
Loading...
Central trial contact
Qihan Fu; Qi Zhang
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal