Evaluating SHR-A2102 with Antitumor Therapy for Advanced Urothelial Carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial aims to assess the safety, tolerability, and efficacy of SHR-A2102 in combination with antitumor therapy for patients with advanced urothelial carcinoma. It will explore the appropriate dosage of SHR-A2102 while monitoring patient responses. Participants will receive injections of SHR-A2102 along with other treatments like Adebrelimab and SHR-8068. The study is designed for patients who have not responded to or are intolerant of standard therapies.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Chun Yang
• Email: chun.yang.cy35@hengrui.com
• Phone: +86 15001953916

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Rimegepant plus toripalimab in advanced urothelial cancer after standard therapy

  This small, early-stage study tests whether combining rimegepant with toripalimab is safe and shows signs of activity in adults with advanced urothelial cancer that did not respond to prior treatment.

  Recruiting at 2 sites Phase 1 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Beijing Municipality and 1 other locations · NCT07835035

• Trastuzumab Rezetecan with or without Adebrelimab for HER2-expressing advanced urothelial cancer

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  Recruiting at 3 sites Phase 2 Sun Yat-sen University · Guangzhou, Guangdong and 5 other locations · NCT07241793

• Pembrolizumab maintenance after initial enfortumab vedotin plus pembrolizumab for frontline metastatic urothelial cancer

  This trial will test whether continuing pembrolizumab after an 18-week course of enfortumab vedotin plus pembrolizumab helps people with previously untreated metastatic urothelial carcinoma.

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• Clofarabine treatment for advanced or metastatic urothelial carcinoma

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• Using probiotics with immunotherapy for advanced bladder cancer

  This study is testing if adding a probiotics treatment to immunotherapy can help people with advanced bladder cancer do better after previous treatments.

  Recruiting Phase 2 Sun Yat-sen University · Guangzhou, Guangdong and 2 other locations · NCT06904573

• Comparing SHR-A2102 to standard therapies for advanced bladder cancer

  This study is testing a new injectable treatment called SHR-A2102 against standard therapies for people with advanced bladder cancer who have already tried other treatments.

  Recruiting Phase 3 Shanghai Hengrui Pharmaceutical Co., Ltd. · Beijing, Beijing Municipality · NCT06738251

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.