RecruitingPhase 1Phase 2NCT05410730

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

Phase I/II Clinical Study of Dose Escalation and Dose Expansion of SHR-1501 Alone or in Combination With Bacille de Calmette Guerin (BCG) or SHR-1316 in the Treatment of Non-muscle Invasive Bladder Cancer(NMIBC)


Sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Enrollment

150 participants

Start Date

Nov 23, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called SHR-1501, alone or combined with BCG (an existing bladder cancer treatment) or SHR-1316 (another immune drug), for people with non-muscle-invasive bladder cancer (NMIBC) that is high risk. These are bladder tumors that haven't grown into the muscle wall yet but have a high chance of coming back. **You may be eligible if...** - You are 18 or older - You have been diagnosed with high-risk NMIBC confirmed by biopsy - A recent cystoscopy (within 6 weeks) showed the tumor has been fully removed or only carcinoma in situ remains - Your general health is good (ECOG score 0–2) - Your expected survival is at least 2 years **You may NOT be eligible if...** - Your cancer has grown into or beyond the muscle of the bladder wall - You have already received certain immunotherapy treatments - Your organ function is not adequate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSHR-1501

SHR-1501 single agent dose escalation, and in combination of BCG or SHR-1316.


Locations(1)

Peking University First Hospital

Beijing, Beijing Municipality, China

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NCT05410730