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Recruiting NCT06639347

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

Phase I / Phase II Interventional Advanced Urothelial Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SHR-A2102, Adebrelimab injection, SHR-8068 injection.
Who it may be relevant to
Registry conditions: Advanced Urothelial Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug SHR-A2102
    SHR-A2102
  • Drug Adebrelimab injection
    Adebrelimab injection
  • Drug SHR-8068 injection
    SHR-8068 injection

Primary outcome measures

  • Phase I: RP2D of SHR-A2102 combined with Adebrelimab and SHR-8068 in patients with advanced urothelial cancer [Time frame: Up to approximately 5 years]
  • Phase I: Incidence and severity of adverse events [Time frame: Up to approximately 5 years]
  • Phase II: ORR by investigator assessment [Time frame: Up to approximately 5 years]
Secondary outcome measures (12)
  • Phase I: ORR by investigator assessment [Time frame: Up to approximately 5 years]
  • Phase I: DCR by investigator assessment [Time frame: Up to approximately 5 years]
  • Phase I: DoR by investigator assessment [Time frame: Up to approximately 5 years]
  • Phase I: PFS by investigator assessment [Time frame: Up to approximately 5 years]
  • Phase I: OS by investigator assessment [Time frame: Up to approximately 5 years]
  • Phase I: Pharmacokinetic parameter for serum concentrations of SHR-A2102 and free toxin [Time frame: Up to approximately 5 years]
  • Phase I: Anti-SHR-A2102 antibody (ADA) and anti-SHR-A2102 neutralizing antibody (NAb) [Time frame: Up to approximately 5 years]
  • Phase II: DCR by investigator assessment [Time frame: Up to approximately 5 years]
  • Phase II: DoR by investigator assessment [Time frame: Up to approximately 5 years]
  • Phase II: PFS by investigator assessment [Time frame: Up to approximately 5 years]
  • Phase II: OS by investigator assessment [Time frame: Up to approximately 5 years]
  • Phase II: Incidence and severity of adverse events [Time frame: up to 5 years]

Eligibility criteria

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Sun Yat-sen University Cancer Center — Guangzhou

Identifiers

NCT: NCT06639347 · SHR-A2102-207

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗