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

Launched by SHANGHAI HENGRUI PHARMACEUTICAL CO., LTD. · Oct 10, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called SHR-A2102 combined with standard antitumor therapies for patients with advanced urothelial carcinoma, a type of bladder cancer that cannot be surgically removed. The main goals of the trial are to see how safe and effective SHR-A2102 is, as well as to find out the best dose to use. The trial is currently looking for participants, including men and women aged 18 and older who have been diagnosed with advanced or metastatic urothelial cancer and have measurable disease. Participants should not have received certain other cancer treatments recently and must be able to provide a tissue sample from their tumor.

If you join the trial, you will receive the study medication and be monitored closely by the research team for any side effects or changes in your condition. It’s important to know that this is an early-phase trial, meaning it’s one of the first steps in testing this treatment, and while it aims to provide new options for patients, there may be risks involved. Before participating, you will need to sign a consent form to ensure you understand the study and its requirements.

Gender

ALL

Eligibility criteria

• 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.