The study is being conducted to evaluate the safety and tolerability of HRS2300 and combined with SHR-1316 or SHR-1701 or trametinib or Almonertinib.To Determine the maximum tolerated dose (MTD) and recommended Dose (RP2D) for HRS2300 monotherapy and combination therapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
13
HRS2300 monotherapy
HRS2300 combined with SHR-1316
HRS2300 combined with SHR-1701
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Number of participants with Dose limited toxicity(DLT)
Time frame: Cycle 1( 4 weeks- monotherapy;3 weeks -combination)
Number of participants with adverse events
Time frame: up to 3 years; at least once per treatment cycle
Determine RP2D of HRS2300 monotherapy and combination in patients with advanced malignancy
Enrolled sequentially from the initial dose of the trial, each subject received only one dose of the study drug and no other dose. The first subject of each dose should complete the first administration and be observed for 7 days before the other two subjects can be enrolled. After the DLT observation period of the last subject in each dose group has ended, the next dose increment can be entered. At the end of the dose escalation phase, the dose closest to the estimated toxicity probability of the target was selected as the MTD . At the end of the dose escalation, the SMC determined the RP2D based on the previous data.
Time frame: through study completion,an average of 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
HRS2300 combined with trametinib
HRS2300 combined with Almonertinib