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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Hengrui Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • SHR-A2102

    Drug

    SHR-A2102

  • Adebrelimab injection

    Drug

    Adebrelimab injection

  • SHR-8068 injection

    Drug

    SHR-8068 injection

Treatment groups

90 Participants
are divided into 1 treatment group
Group A: SHR-A2102 + Adebrelimab injection+SHR-8068 injectionExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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
2

Phase I: Incidence and severity of adverse events

Time frame
Up to approximately 5 years
3

Phase II: ORR by investigator assessment

Time frame
Up to approximately 5 years

Secondary outcomes

1

Phase I: ORR by investigator assessment

Time frame
Up to approximately 5 years
2

Phase I: DCR by investigator assessment

Time frame
Up to approximately 5 years
3

Phase I: DoR by investigator assessment

Time frame
Up to approximately 5 years
4

Phase I: PFS by investigator assessment

Time frame
Up to approximately 5 years

Other outcomes

Sponsors and contacts

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