This is a non-randomized,open-label,controlled multi-center Phase Ⅰ study to evaluate tolerability, pharmacokinetics, and preliminary efficacy of BM201 injection in combination with radiotherapy in patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors who have failed standard therapy or are unable to receive standard treatment.
This is a Phase I, open-label clinical study primarily designed to evaluate the safety and tolerability of BM201 injection in combination with radiotherapy in patients with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Radiation: Hypofractionated radiotherapy
BM201 injection:Dose escalation:24mg to 240mg
Nanjing Drum Towel Hospital /The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
RECRUITINGDLT and MTD
Dose limiting toxicity and maximum tolerated dose
Time frame: Up to 14 days after the initial treatment
Pharmacokinetic (PK) parameters
Maximum plasma concentration(Cmax) of the drug after administration
Time frame: From pre-dose to 96 hrs post-dose
Number of patients with adverse events (AEs)
Number of patients with treatment-related adverse events (AEs)
Time frame: From the first treatment to 42 days after the last treatment.
ORR
Objective Response Rate
Time frame: Up to 42 days after the last treatment
Peripheral blood cytokine profiling in study participants.
To investigate the change of peripheral blood cytokine level in subjects after the treatment.
Time frame: From pre-dose/pre-radiation to 4 hrs post-dose/post-radiation.
The variation in peripheral blood tumor biomarker concentrations.
The variation of concentrations of AFP,NSE,CEA ;
Time frame: Up to 42 days after the last treatment
Other exploring outcomes
The variation of tumor tissue biomarker expression levels
Time frame: Up to 14 days after the initial treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.