About this trial
The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 for injection with or without Antitumor Therapy in Advanced Solid Tumors. To explore the reasonable dosage of SHR-A2102 for Advanced Solid Tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Have the ability to give informed consent, have signed informed and able to comply with the treatment plan to visit the tests and other procedural requirements;
The age of signing the informed consent is above 18 years old, regardless of gender; for the SHR-A2102 combined with Disitamab Vedotin cohort, the maximum upper limit was 80 years old
The ECOG score is 0 or 1;
Expected survival ≥12 weeks
Disqualifiers
Inadequately treated central nervous system metastases or the presence of uncontrolled or symptomatic active central nervous system metastases;
Have previously received antiboy-coupled drugs containing topoisomerase I inhibitors; Stage II was previously treated with PD-1/PD-L1 inhibitors;For the SHR-A2102 combined with Disitamab Vedotin cohort, those who have previously received Disitamab Vedotin treatment or antibody-drug conjugates containing topoisomerase I inhibitors
Systemic antitumor therapy was received 4 weeks before the start of the study;
Palliative radiotherapy was completed within 14 days before the first dose; Chest radiotherapy >30 Gy within 6 months prior to initial administration;
Trial design
Parallel
Treatments tested in this trial
SHR-A2102
DrugSHR-A2102
SHR-A2102 ; Adebrelimab injection
DrugSHR-A2102 + Adebrelimab injection
SHR-A2102 + Disitamab Vedotin For Injection
DrugSHR-A2102 + Disitamab Vedotin For Injection
Treatment groups
Trial outcomes
Primary outcomes
RP2D
Incidence and severity of AE;
ORR
Secondary outcomes
DCR(Investigator evaluation)
DoR(Investigator evaluation)
PFS(Investigator evaluation)
OS(Investigator evaluation)
Sponsors and contacts
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