Evaluating SHR-A2102 with Antitumor Therapy for Advanced Urothelial Carcinoma

An Open Label, Multicenter, Phase Ib/Il Study to Evaluate the Safety, Tolerability, and Efficacy of SHR A2102 in Combination With Other Anti-cancer Agents in Patients With Advanced Urothelial Carcinoma

This study is testing a new treatment called SHR-A2102 combined with other therapies to see if it can help patients with advanced urothelial carcinoma who haven't had success with standard treatments.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06639347 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 or older with unresectable locally advanced or metastatic urothelial carcinoma who have measurable disease.

Not a fit: Patients with active CNS metastases or those who have previously received specific anti-cancer treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced urothelial carcinoma who have limited treatment choices.

How similar studies have performed: While this approach is being evaluated, similar studies have shown promise in targeting advanced urothelial carcinoma with novel therapies.

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.

Where this trial is running

Guangzhou, Guangdong

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

Study contacts

• Study coordinator: Chun Yang

Conditions Advanced Urothelial Carcinoma