This study is designed to evaluate the safety and efficacy of QLF31907 combination therapy in advanced malignant tumors.
subjects voluntarily participated and signed a written informed consent form;
age ≥18 years, male or female;
ECOG PS 0-1;
histopathologically diagnosed advanced malignant tumors;
previous treatment with 4-1BB agonist or 4-1BB recombinant fusion protein;
received anti-tumor therapy within 4 weeks prior to the first study treatment;
history of autoimmune disease;
history of other active malignancies within 3 years prior to the first treatment;
Sequential
QLF31907
Drugintravenous administration, once every 3 weeks
Irinotecan
Drugintravenous administration, 125 mg/m2, d1 and d8, every 3 weeks
Docetaxel
Drugintravenous administration, 75mg/m2, d1, every 3 weeks
phase Ib: Dose-limiting toxicity(DLT)
The DLT of QLF31907 combination therapy will be determined
phase2: objective response rate(ORR)
the ORR of QLF31907 combinaton therapy will be determined
adverse events (AEs) of QLF31907 combination therapy
to evaluate the severity, incidence and causality of adverse events (AEs)
area under the concentration-time curve (AUC) of QLF31907
the area under the concentration-time curve (AUC) of QLF31907 will be determined
Immunogenicity of QLF31907
the anti-drug antibody(ADA) against QLF31907 will be determined
overall survival(OS)
the OS of QLF31907 combination therapy will be determined
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This trial is not recruiting at the moment. You can still explore other options:
