About this trial
The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 for injection with Antitumor Therapy in Advanced Urothelial Carcinoma. To explore the reasonable dosage of SHR-A2102 for Advanced Urothelial Carcinoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Competent to comprehend, sign, and date an informed consent form.
Male or female subjects must be age 18 or older.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Subjects must have histologically documented, unresectable locally advanced or
Disqualifiers
Subjects with not adequately treated, or uncontrollable , or active CNS metastases.
Subjects who have previously received TOPO1-based ADCs.
Subjects who have received anti-cancer treatment within 4 weeks prior the first dose of study treatment.
Subjects who have received radiotherapy within 14 days , or chest radiotherapy > 30Gy within 6 months prior to the first dose of study drug.
Trial design
Single group
Treatments tested in this trial
SHR-A2102
DrugSHR-A2102
Adebrelimab injection
DrugAdebrelimab injection
SHR-8068 injection
DrugSHR-8068 injection
Treatment groups
Trial outcomes
Primary outcomes
Phase I: RP2D of SHR-A2102 combined with Adebrelimab and SHR-8068 in patients with advanced urothelial cancer
Phase I: Incidence and severity of adverse events
Phase II: ORR by investigator assessment
Secondary outcomes
Phase I: ORR by investigator assessment
Phase I: DCR by investigator assessment
Phase I: DoR by investigator assessment
Phase I: PFS by investigator assessment
Sponsors and contacts
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