Advanced Urothelial Carcinoma
Conditions
Brief summary
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.
Interventions
Sponsors
Shanghai Hengrui Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
SHR-A2102 with antitumor therapy
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Competent to comprehend, sign, and date an informed consent form. 2. Male or female subjects must be age 18 or older. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Subjects must have histologically documented, unresectable locally advanced or 5. Histologically confirmed locally advanced or metastatic urothelial cancer.Phase Ib, subjects must have failed, be intolerant or refused the standard treatment; Phase II, subjects must not have received systemic antitumor therapy for locally advanced unresectable or metastatic urothelial carcinoma. 6. An archival tumor tissue sample or a fresh tissue sample should be provided. 7. Subjects must have measurable disease according to RECIST (version 1.1).
Exclusion criteria
1. Subjects with not adequately treated, or uncontrollable , or active CNS metastases. 2. Subjects who have previously received TOPO1-based ADCs. 3. Subjects who have received anti-cancer treatment within 4 weeks prior the first dose of study treatment. 4. Subjects who have received radiotherapy within 14 days , or chest radiotherapy \> 30Gy within 6 months prior to the first dose of study drug. 5. Subjects with ongoing clinically significant toxicity associated with prior treatment that has not resolved to ≤ Grade 1. 6. Subjects who have received systemic immunosuppressant treatment within 14 days prior the first dose of study treatment. 7. Subjects who have known or suspected interstitial pneumonitis. 8. Phase Ib: Subjects who have had≥ Grade 3 irAEs during the previous treatment with ICIs. 9. Subjects who have any active, known or suspected autoimmune diseases. 10. Subjects who have moderate or severe ascites with clinical symptoms, or uncontrolled or moderate or above pleural effusion, or pericardial effusion. 11. Subjects who have uncontrolled cardiac diseases or cardiac clinical symptoms.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: RP2D of SHR-A2102 combined with Adebrelimab and SHR-8068 in patients with advanced urothelial cancer | Up to approximately 5 years |
| Phase I: Incidence and severity of adverse events | Up to approximately 5 years |
| Phase II: ORR by investigator assessment | Up to approximately 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Phase I: PFS by investigator assessment | Up to approximately 5 years |
| Phase I: OS by investigator assessment | Up to approximately 5 years |
| Phase I: Pharmacokinetic parameter for serum concentrations of SHR-A2102 and free toxin | Up to approximately 5 years |
| Phase I: Anti-SHR-A2102 antibody (ADA) and anti-SHR-A2102 neutralizing antibody (NAb) | Up to approximately 5 years |
| Phase II: DCR by investigator assessment | Up to approximately 5 years |
| Phase I: ORR by investigator assessment | Up to approximately 5 years |
| Phase II: PFS by investigator assessment | Up to approximately 5 years |
| Phase II: OS by investigator assessment | Up to approximately 5 years |
| Phase II: Incidence and severity of adverse events | up to 5 years |
| Phase II: Pharmacokinetic parameter for serum concentrations of SHR-A2102 and free toxin | Up to approximately 5 years |
| Phase II: Anti-SHR-A2102 antibody (ADA) and anti-SHR-A2102 neutralizing antibody (NAb) | Up to approximately 5 years |
| Phase II: DoR by investigator assessment | Up to approximately 5 years |
| Phase I: DCR by investigator assessment | Up to approximately 5 years |
| Phase I: DoR by investigator assessment | Up to approximately 5 years |
Countries
China
Contacts
Primary ContactChun Yang
Outcome results
None listed