A Trial of SHR-A2102 With Antitumor Therapy in Advanced Urothelial Carcinoma

Recruiting now · Phase 1/Phase 2

Conditions studied: Advanced Urothelial Carcinoma

In brief

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.

Key facts

Study ID

NCT06639347

Run by

Shanghai Hengrui Pharmaceutical Co., Ltd.

People needed

90

Starts

2024-11-04

Expected to finish

2027-05-31

Last updated by the study team

2024-11-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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.
• An archival tumor tissue sample or a fresh tissue sample should be provided.
• Subjects must have measurable disease according to RECIST (version 1.1).

You may not qualify if…

• 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.
• Subjects with ongoing clinically significant toxicity associated with prior treatment that has not resolved to ≤ Grade 1.
• Subjects who have received systemic immunosuppressant treatment within 14 days prior the first dose of study treatment.
• Subjects who have known or suspected interstitial pneumonitis.
• Phase Ib: Subjects who have had≥ Grade 3 irAEs during the previous treatment with ICIs.
• Subjects who have any active, known or suspected autoimmune diseases.
• Subjects who have moderate or severe ascites with clinical symptoms, or uncontrolled or moderate or above pleural effusion, or pericardial effusion.
• Subjects who have uncontrolled cardiac diseases or cardiac clinical symptoms.

Where it is running

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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