A Trial of SHR-A2102 With Antitumor Therapy in 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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Urothelial Carcinoma
• Intervention / Treatment: Drug: SHR-A2102; Drug: Adebrelimab injection; Drug: SHR-8068 injection

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Chun Yang; Phone Number: +86 15001953916; Email: chun.yang.cy35@hengrui.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-sen University Cancer Center
      • Contact: Fangjian Zhou; Email: zhoufj@sysucc.org.cn
      • Contact: Yanxia Shi; Email: shiyx@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-A2102 + Adebrelimab injection+SHR-8068 injection	Drug: SHR-A2102; SHR-A2102; Drug: Adebrelimab injection; Adebrelimab injection; Drug: SHR-8068 injection; SHR-8068 injection

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Phase I: ORR 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
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 II: DoR 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

Collaborators and Investigators

• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: October 10, 2024
• First Submitted That Met QC Criteria: October 10, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 15, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Carcinoma, Transitional Cell
• Other Study ID Numbers: SHR-A2102-207

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No