A Study of SHR-1501 Alone or in Combination With BCG or SHR-1316 in Subjects With NMIBC

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

About this trial

The study is to evaluate the safety and tolerability of SHR-1501 alone or in combination with BCG or SHR-1316 in the patients with NMIBC, and to determine the RP2D of SHR-1501 in combination with BCG or SHR-1316.

To evaluate the preliminary efficacy of SHR-1501 alone or in combination with BCG or SHR-1316 in the treatment of NMIBC.

Eligibility criteria

Qualifiers

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

Age ≥ 18 years old, gender is not limited;

Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;

Expected survival time ≥ 2 years;

Disqualifiers

Received surgery or radiotherapy for bladder lesions within 2 weeks before the first administration;

Intravesical instillation of cytotoxic chemotherapy or other drugs;

Immune checkpoint inhibitor;

Other investigational products for the treatment of NMIBC.

Trial design

Treatments tested in this trial

  • SHR-1501

Treatment groups

150 Participants
are divided into 1 treatment group