A Phase III Study of SHR-A2102 Versus Investigator-selected Therapy in Advanced Urothelial Carcinoma

NCT06738251 | Recruiting Phase 3

• 1 other identifier: SHR-A2102-301
• Study Type: interventional
• Target: 402
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of SHR-A2102 for injection versus Investigator-selected Therapy in patients with Locally advanced or Metastatic Urothelial Carcinoma who have been previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors.

Conditions

Advanced Urothelial Carcinoma

Outcome Measures

Primary Outcomes (2)

• Progression-free Survival (PFS)

  Up to approximately 1.5 years.

• Overall Survival (OS)

  Up to approximately 1.5 years and 2 years.

Secondary Outcomes (9)

• Objective Response Rate (ORR)

  Up to approximately 1.5 years and 2 years.

• Disease Control Rate (DCR)

  Up to approximately 1.5 years and 2 years.

• Duration of Response (DoR)

  Up to approximately 1.5 years and 2 years.

• Serum concentrations of SHR-A2102

  Up to approximately 2 years.

• Serum concentrations of SHR-A2102 toxin

  Up to approximately 2 years.

Study Arms (2)

SHR-A2102 group

EXPERIMENTAL

Drug: SHR-A2102 for Injection

Investigator-selected therapy group

ACTIVE COMPARATOR

Drug: Docetaxel Injection; Drug: Paclitaxel Injection; Drug: Gemcitabine Hydrochloride for Injection; Drug: Pemetrexed Disodium for Injection

Interventions

SHR-A2102 for Injection DRUG

SHR-A2102 for Injection.

SHR-A2102 group

Docetaxel Injection DRUG

Docetaxel Injection.

Investigator-selected therapy group

Paclitaxel Injection DRUG

Paclitaxel Injection.

Investigator-selected therapy group

Gemcitabine Hydrochloride for Injection DRUG

Gemcitabine Hydrochloride for Injection.

Investigator-selected therapy group

Pemetrexed Disodium for Injection DRUG

Pemetrexed Disodium for Injection.

Investigator-selected therapy group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily participate in this clinical study, understand the study procedures and be able to sign the informed consent form in writing.
• to 80 years old (including boundary value), gender is not limited.
• ECOG performance status score of 0 or 1.
• Estimated survival ≥ 3 months.
• Pathologically confirmed urothelial carcinoma confirmed by imaging or other methods as locally advanced unresectable or metastatic disease.
• Patients with locally advanced or metastatic disease who have previously received both a platinum-based chemotherapy regimen and a PD-(L)1 inhibitor; patients who received platinum-based chemotherapy and/or a PD-(L)1 inhibitor as neoadjuvant or adjuvant therapy and experienced recurrence or progression during treatment or within 6 months after completing treatment will be considered to have received these therapies in the locally advanced/metastatic setting.
• Imaging-confirmed disease progression during or after treatment with the most recent regimen.
• Able to provide preserved or fresh tumor tissue.
• Must be present with at least one measurable lesion according to RECIST v1.1 criteria.
• Good level of organ function.
• Male subjects whose partners are women of childbearing potential and female subjects of childbearing potential must use highly effective contraception from the time of signing the informed consent form until 8 months after the last dose of the trial drug.

You may not qualify if:

• Planned to receive any other anti-tumor therapy during this trial.
• Receipt of other unmarketed clinical trial drugs or treatments within 4 weeks prior to randomization.
• Received systemic anti-tumor therapy such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks prior to randomization, and palliative radiotherapy or local therapy within 2 weeks prior to the first use of the investigational drug.
• Prior receipt of antibody-drug conjugates containing topoisomerase I inhibitors in the composition.
• For locally advanced or metastatic disease: patients who have previously received more than three lines of systemic therapy in this setting.For neoadjuvant or adjuvant therapy: if the disease recurs or progresses during treatment or within 6 months after its completion, the patient is considered to have received first-line systemic therapy for locally advanced or metastatic disease.
• Prior treatment with more than 1 antibody-drug conjugate.
• Major surgery other than diagnosis or biopsy within 4 weeks prior to randomization that requires elective surgery during the trial.
• Received systemic glucocorticoids (prednisone \> 10 mg/day or equivalent dose) or other immunosuppressants within 14 days prior to the first use of investigational drug or randomization for immunosuppressive purposes.
• Adverse events from prior antineoplastic therapy did not recover to Grade ≤1 according to NCI-CTCAE v5.0.
• Inadequately treated central nervous system (CNS) metastases, or the presence of uncontrolled or symptomatic active central nervous system metastases. CNS metastases that have been adequately treated and whose neurological symptoms are able to return to baseline at least 4 weeks prior to randomization (with the exception of residual signs or symptoms associated with CNS treatment) may be enrolled in the study.
• Subject has a serous effusion with clinical symptoms or requiring puncture and drainage.
• Any malignancy diagnosed within 5 years prior to randomization (calculated from the date of the last anti-tumor treatment), except:Localized, low-risk prostate cancer.Papillary thyroid carcinoma, basal-cell carcinoma, or squamous-cell carcinoma of the skin that has been adequately treated and shows no evidence of disease.Other carcinomas in situ that have been adequately treated and show no evidence of disease recurrence.
• History of interstitial pneumonitis/interstitial lung disease or non-infectious pneumonitis (e.g., radiation pneumonitis) that required systemic corticosteroid therapy.Current evidence, in the investigator's judgment, of uncontrolled interstitial pneumonitis/interstitial lung disease, non-infectious pneumonitis, or any other active pneumonitis.
• Severe infections requiring intravenous antibiotics, antivirals, or antifungals for control.
• Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.

Sponsors & Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Interventions

Injections; Docetaxel; Paclitaxel; Gemcitabine; Pemetrexed

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Central Study Contacts

Chi Zhang, M.M

CONTACT

+86-18456513908; chi.zhang@hengrui.com

Zhaoxiang Wang, M.M

CONTACT

+86-19181783204; zhaoxiang.wang.zw170@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 17, 2024
• Study Start: February 12, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 17, 2025

Record last verified: 2025-03

Locations

CN (1)