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

NCT05410730 | Recruiting Phase 1

• 1 other identifier: SHR-1501-I-103
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

High-risk NMIBC

Outcome Measures

Primary Outcomes (5)

• Dose-limiting toxicity

  21 Days

• Maximum tolerated dose

  Approximately 2years

• Recommended Phase 2 dose (RP2D)

  Approximately 2 years.

• CR Rate (cohort 2)

  Approximately 4 years.

• 12-month DFS Rate (cohort 1、3、4)

  Approximately 4 years

Secondary Outcomes (17)

• Treatment-Related Adverse Events as assessed by CTCAE v5.0

  Approximately 4 years.

• Duration of CR (DoR)

  Approximately 4 years.

• CR rate at 6 months and 18 months

  Approximately 4 years.

• DFS

  Approximately 4 years.

• Time to cystectomy,

  Approximately 4 years.

Study Arms (1)

SHR-1501

EXPERIMENTAL

* Phase I：Phase Ia and Ib： Phase Ia include SHR-1501 dose escalation and expansion; Phase Ib ： SHR-1501 in combination with BCG or SHR-1316 dose escalation * Phase II：SHR-1501 in combination with BCG or SHR-1316 dose expansion in NMIBC

Drug: SHR-1501

Interventions

SHR-1501 DRUG

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

SHR-1501

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• High-risk NMIBC diagnosed by previous pathological biopsy
• 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;
• ineligible or unwilling to undergo radical cystectomy;
• The level of organ function is good.
• 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.

You may not qualify if:

• Received surgery or radiotherapy for bladder lesions within 2 weeks before the first administration;
• 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.
• Currently receiving study treatment in other clinical trials or less than 4 weeks from last participation to the first administration of this study;
• 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;
• Previous medical history or examination suggests active tuberculosis within 1 year prior to the first dose;
• Serious infection within 4 weeks before the first administration, or undefined fever\>38.5 ℃ during screening/before the first administration;
• Obvious urinary tract infections and gross hematuria, indicating safety issues assessed by the investigators;
• Patients who discontinued treatment due to adverse reactions such as toxemia, systemic infection or urinary incontinence during previous BCG treatment;
• Using of immunosuppressive drugs within 2 weeks prior to the first administration, excluding nasal and inhaled corticosteroids, low physiological doses of systemic steroids, and prophylactic anti allergic steroids;
• Active or history of interstitial lung disease;
• History of clinically significant cardiovascular disease
• A history of immunodeficiency, including HIV seropositive, other acquired or congenital immunodeficiency diseases, a history of organ transplantation, or those who are using immunosuppressants;

Sponsors & Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Central Study Contacts

Wenliang Wang

CONTACT

+0518-81220121; Wenliang.wang@hengrui.com

Zhijun Yu

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Group .Dose escalation and expansion of SHR-1501 alone or in combination with BCG or SHR-1316 in the treatment of NMIBC

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: June 8, 2022
• Study Start: November 23, 2022
• Primary Completion: May 1, 2025
• Study Completion (Estimated): May 1, 2027
• Last Updated: January 28, 2025

Record last verified: 2024-07

Locations

CN (1)