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A Study of SHR-1501 Alone or in Combination With BCG or SHR-1316 in Subjects With NMIBC | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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）

NCT05410730•Shanghai Hengrui Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Voluntarily participate in this clinical study, understand the research procedures and be able to sign the informed consent in writing;
•2. Age ≥ 18 years old, gender is not limited;
•3. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;
•4. Expected survival time ≥ 2 years;
•5. High-risk NMIBC diagnosed by previous pathological biopsy
•6. Cystoscopy within 6 weeks before the first administration shows that the lesion has been completely removed, or the residual lesion is only carcinoma in situ; for T1 stage lesions, postoperative pathological results must show the presence of bladder muscle tissue;
•7. ineligible or unwilling to undergo radical cystectomy;
•8. The level of organ function is good.
•9. use contraceptive measures (such as intrauterine device and contraceptive pill) during the study treatment period and within 3 months after the end of the study treatment period, and the female subject and the female partner of the male subject should use highly effective contraceptive methods; the female subject of childbearing age without surgical sterilization must be negative for serum HCG within 7 days before the first administration and must be non-lactating.

Exclusion Criteria

•1. Received surgery or radiotherapy for bladder lesions within 2 weeks before the first administration;
•2. Those who have previously received the following treatments and have not experienced disease progression before enrolment t as assessed by the investigator:
•* Intravesical instillation of cytotoxic chemotherapy or other drugs;
•* Immune checkpoint inhibitor;
•* Other investigational products for the treatment of NMIBC.
•3. Currently receiving study treatment in other clinical trials or less than 4 weeks from last participation to the first administration of this study;
•4. Upper urinary tract tumor detected by CTU or MRU during screening period, urethral prostate tumor detected by cystoscopy, or other concomitant malignant tumors within 5 years before the first administration;
•5. Previous medical history or examination suggests active tuberculosis within 1 year prior to the first dose;
•6. Serious infection within 4 weeks before the first administration, or undefined fever\>38.5 ℃ during screening/before the first administration;
•7. Obvious urinary tract infections and gross hematuria, indicating safety issues assessed by the investigators;
+9 more criteria

Locations (1)

Peking University First Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

November 23, 2022

Primary Completion Date

May 1, 2025

Completion Date

May 1, 2027

Last Updated

January 28, 2025

Enrollment

150

ESTIMATED participants

Conditions

High-risk NMIBC

Interventions

SHR-1501

DRUG

Contacts

Wenliang Wang

CONTACT

+0518-81220121 Wenliang.wang@hengrui.com

Zhijun Yu

CONTACT

+0518-82342973 zhijun.yu.zy19@hengrui.com