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

ConditionAdvanced Urothelial Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Hengrui Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily participate in this clinical study, understand the study procedures and be able to sign the informed consent form in writing.

18 to 80 years old (including boundary value), gender is not limited.

ECOG performance status score of 0 or 1.

Estimated survival ≥ 3 months.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SHR-A2102 for Injection

    Drug

    SHR-A2102 for Injection.

  • Docetaxel Injection

    Drug

    Docetaxel Injection.

  • Paclitaxel Injection

    Drug

    Paclitaxel Injection.

  • Gemcitabine Hydrochloride for Injection

    Drug

    Gemcitabine Hydrochloride for Injection.

  • Pemetrexed Disodium for Injection

    Drug

    Pemetrexed Disodium for Injection.

Treatment groups

402 Participants
are divided into 2 treatment groups
Group A: SHR-A2102 groupExperimental treatment 1 intervention
Group B: Investigator-selected therapy groupActive comparator 4 interventions

Trial outcomes

Primary outcomes

1

Progression-free Survival (PFS)

Time frame
Up to approximately 1.5 years.
2

Overall Survival (OS)

Time frame
Up to approximately 1.5 years and 2 years.

Secondary outcomes

1

Objective Response Rate (ORR)

Time frame
Up to approximately 1.5 years and 2 years.
2

Disease Control Rate (DCR)

Time frame
Up to approximately 1.5 years and 2 years.
3

Duration of Response (DoR)

Time frame
Up to approximately 1.5 years and 2 years.
4

Serum concentrations of SHR-A2102

Time frame
Up to approximately 2 years.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Hengrui Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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