This study is a multicentre, open phase II clinical study of dose escalation, dose extension and efficacy extension of HRS-7058 in combination with antitumor drugs in subjects with advanced malignant tumour. To evaluate the safety, tolerability and efficacy of HRS-7058 in combination with antitumor drugs.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
HRS-7058 + SHR-1316
HRS-7058 + SHR-1316 + Platinum-containing doublet chemotherapy
HRS-7058 + Cetuximab
Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China
RECRUITINGTianjin Cancer Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGDose-limiting toxicity (DLT) (Dose Escalation and Dose Expansion)
Time frame: From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months
Safety endpoints: adverse events (AE) (Dose Escalation and Dose Expansion)
Time frame: From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months]
Phase II recommended dose (RP2D)(Dose Escalation and Dose Expansion)
Time frame: From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months]
Efficacy endpoints: Objective response rate (ORR) assessed based on RECIST v1.1 criterion (Efficacy Expansion)
Time frame: From the beginning of first patient in (FPI) to the end of study up to approximately 32 months
Efficacy endpoints: Objective response rate (ORR) assessed based on RECIST v1.1 criterion (Dose Escalation and Dose Expansion)
Time frame: From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months
Efficacy endpoints: disease control rate (DCR) assessed based on RECIST v1.1 criterion (Dose Escalation and Dose Expansion)
Time frame: From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months
Efficacy endpoints: duration of response (DoR) assessed based on RECIST v1.1 criterion (Dose Escalation and Dose Expansion)
Time frame: From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months
Efficacy endpoints: progression-free survival (PFS) assessed based on RECIST v1.1 criterion (Dose Escalation and Dose Expansion)
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HRS-7058 + SHR-1826
HRS-7058 + SHR-1826 + SHR-1316
HRS-7058 + SHR-A1202
HRS-7058 + BP102
HRS-7058 + SHR-9839
HRS-7058 +SHR-A2102 +SHR-1316
HRS-7058 +SHR-9839(sc)+SHR-1316
HRS-7058 +SHR-1316 +BP102
HRS-7058 +SHR-A2102 +BP102
HRS-7058 +SHR-A2102 +SHR-1316 +BP102
Time frame: From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months
Efficacy endpoints: overall survival (OS)(Dose Escalation and Dose Expansion)
Time frame: From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months
Efficacy endpoints: disease control rate (DCR) assessed based on RECIST v1.1 criterion (Efficacy Expansion)
Time frame: From the beginning of first patient in (FPI) to the end of study up to approximately 32 months
Efficacy endpoints: duration of response (DoR) assessed based on RECIST v1.1 criterion (Efficacy Expansion)
Time frame: From the beginning of first patient in (FPI) to the end of study up to approximately 32 months
Efficacy endpoints: progression-free survival (PFS) assessed based on RECIST v1.1 criterion (Efficacy Expansion)
Time frame: From the beginning of first patient in (FPI) to the end of study up to approximately 32 months
Efficacy endpoints: overall survival (OS) (Efficacy Expansion)
Time frame: From the beginning of first patient in (FPI) to the end of study up to approximately 32 months
Safety endpoints: adverse events (AE)(Efficacy Expansion)
Time frame: From the beginning of first patient in (FPI) to the end of study up to approximately 32 months