About this trial
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-4602 as montherapy or in combination with other anti-tumor therapies in advanced solid tumors. To explore the reasonable dosage of SHR-4602 for advanced solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18-80 years old;
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
Stage I: subjects with pathologically confirmed locally advanced unresectable or metastatic solid tumors, who have failed at least 1 line of standard treatment;
Provide archived or fresh tumor tissue;HER2 expression is required for subjects in Stage I;
Disqualifiers
Inadequately treated central nervous system metastases or the presence of uncontrolled or symptomatic active central nervous system metastases;
Subjects with peripheral neuropathy;
Have received anti-cancer treatment within 4 weeks prior the first dose of study treatment;
Are participating in another clinical study or have received the last dose in a clinical study less than 4 weeks from the first dose;
Trial design
Single group
Treatments tested in this trial
SHR-4602
DrugSHR-4602
Treatment groups
Trial outcomes
Primary outcomes
ORR by investigator assessment
ORR by investigator assessment was defined as the percentage of participants with confirmed complete response (CR) or partial response (PR), Up to approximately 5 years;
Secondary outcomes
DCR by investigator assessment,
DCR by investigator assessment was defined as the percentage of participants with confirmed response (CR or PR), or SD, per RECIST v1.1 per investigator, Up to approximately 5 years;
DoR by investigator assessment,
DoR was defined as the time from the first objective response (CR or PR that is subsequently confirmed) to the first documented PD per RECIST v1.1 per investigator or death from any cause, whichever occurs first, Up to approximately 5 years;
PFS by investigator assessment,
PFS was defined as the time from date of start of study treatment to first documentation of disease progression (PD), or to death due to any cause, whichever occurred first, Up to approximately 5 years;
OS
OS is defined as the time from start of study treatment to death from any cause, Up to approximately 5 years;
Sponsors and contacts
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