This include two parts, Stage 1 is a dose climbing study and Stage 2 is a dose extending study.
This study is a study of MAX-40279 in patients with advanced / metastatic solid tumors. This study include two Parts, the Part 1 will assess the safety and efficacy of the dose climbing level of MAX-40279, and recommend a dose extending level of MAX-40279 for stage 2.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
108
\[Stage 1\]The starting dose of MAX-40279 was 35 mg BID, and three dose levels were initially set: 35 mg, 50 mg, and 70 mg administered twice daily (BID) continuously, and the dose of KN046 was 5 mg/kg as a fixed dose administered every 3 weeks. \[Stage 2\]When the RP2D dose is obtained in the dose-finding phase, the trial will enter the dose expansion phase.
DLT
Time frame: through study Stage1 completion,an average of 6 months
Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose (RP2D)
Time frame: through study Stage1 completion,an average of 6 months
ORR
Time frame: through study Stage2 completion,an average of 24 months
PFS
Time frame: through study Stage2 completion,an average of 24 months
Adverse events (AEs), serious adverse events (SAEs)
Time frame: through study Stage2 completion,an average of 24 months
laboratory tests
Time frame: through study Stage2 completion,an average of 24 months
vital signs
Time frame: through study Stage2 completion,an average of 24 months
12 ECG
Time frame: through study Stage2 completion,an average of 24 months
physical examination abnormalities
Time frame: through study Stage2 completion,an average of 24 months
Adverse events (AEs), serious adverse events (SAEs)
Time frame: through study Stage1 completion,an average of 6 months
Cmax
Time frame: through study Stage1 completion,an average of 6 months
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Anti-KN046 antibody (ADA
Time frame: through study Stage1 completion,an average of 6 months
Duration of response (DOR) Overall survival (OS); Anti-KN046 antibody (ADA); Plasma concentrations of MAX-40279 and KN046 [Stage 2]
Time frame: through study Stage2 completion,an average of 24 months
(AUC0-t and AUC0-t, ss)
Time frame: through study Stage1 completion,an average of 6 months
Tmax
Time frame: through study Stage1 completion,an average of 6 months
Overall response rate (ORR)
Time frame: through study Stage1 completion,an average of 6 months
disease control rate (DCR)
Time frame: through study Stage1 completion,an average of 6 months
duration of response (DOR)
Time frame: through study Stage1 completion,an average of 6 months
progression-free survival (PFS)
Time frame: through study Stage1 completion,an average of 6 months
overall survival (OS)
Time frame: through study Stage1 completion,an average of 6 months
DcR
Time frame: through study Stage2 completion,an average of 24 months
DoR
Time frame: through study Stage2 completion,an average of 24 months
OS
Time frame: through study Stage2 completion,an average of 24 months
Anti-KN046 antibody (ADA)
Time frame: through study Stage2 completion,an average of 24 months
Rac (AUC0-t, ss/AUC0-t)
Time frame: through study Stage1 completion,an average of 6 months
laboratory tests
Time frame: through study Stage1 completion,an average of 6 months
vital signs
Time frame: through study Stage1 completion,an average of 6 months
12 ECG
Time frame: through study Stage1 completion,an average of 6 months
physical examination abnormalities
Time frame: through study Stage1 completion,an average of 6 months