A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIM0237 Alone or in Combination with BCG in NMIBC

January 13, 2025 updated by: Jiangsu Simcere Pharmaceutical Co., Ltd.

An Open-Label, Multicenter Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIM0237 Alone or in Combination with BCG in Non-Muscle-Invasive Bladder Cancer

This is an open-label, multicenter phase 1 study to evaluate the safety, efficacy, and pharmacokinetics (PK) characteristics of SIM0237 alone or in combination with bacillus Calmette-Guerin (BCG) in participants with Non-Muscle-Invasive Bladder Cancer (NMIBC)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study starts with a dose escalation part followed by a dose expansion part. The primary objective of the dose escalation part is to evaluate the safety and tolerability of SIM0237 alone or in combination with BCG, and determine the recommended dose(s) (RD). The primary objective of the dose expansion part is to evaluate the preliminary efficacy of SIM0237 alone or in combination with BCG.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
152

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-Sen University Cancer Center
        • Contact:
    • Heilongjiang
      • Haerbin, Heilongjiang, China, 150000
        • Not yet recruiting
        • Harbin Medical University Cancer Hospital
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Not yet recruiting
        • Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430060
        • Not yet recruiting
        • Renmin Hospital of Wuhan University
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410031
    • Shandong
      • Jinan, Shandong, China, 250012
        • Not yet recruiting
        • Qilu Hospital of Shandong University
        • Contact:
      • Qingdao, Shandong, China, 266071
    • Shanghai
      • Shanghai, Shanghai, China, 200092
        • Not yet recruiting
        • Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
        • Contact:
      • Shanghai, Shanghai, China, 201321
        • Enrolling by invitation
        • Fudan University Shanghai Cancer Center
    • Shanxi
      • Taiyuan, Shanxi, China, 30012
        • Not yet recruiting
        • First Hospital of Shanxi Medcial University
        • Contact:
          • Xiaoming Cao
          • Phone Number: +86 13991205917
          • Email: drcxm@126.com
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Not yet recruiting
        • West China Hospital of Sichuan University
        • Contact:
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China, 300211
        • Recruiting
        • The Second Hospital of Tianjin Medical University
        • Contact:
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325015
        • Not yet recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Written informed consent.
  • ≥ 18 years of age, male or female.
  • • Histologically confirmed presence of BCG-unresponsive CIS (with or without Ta or T1 disease) or histologically confirmed presence of BCG-unresponsive high-grade Ta or T1 disease. Histologic confirmation of urothelial carcinoma (mixed histology tumors allowed if urothelial histology is predominant histology).
  • Dose escalation phase: BCG-unresponsive high-risk NMIBC.
  • Dose expansion phase: a) Cohorts 1 and 3: BCG-unresponsive CIS (with or without Ta or T1 disease); b) Cohort 2 and 4: BCG-unresponsive high-risk Ta or T1 disease.
  • Absence of resectable disease after transurethral resection (TURBT) procedures [residual carcinoma in situ (CIS) acceptable]. patients with T1 tumors must undergo repeat resection and pathological test if initial pathological test sample did not include muscularis propria, to ensure the inclusive of muscularis propria and the absence of invasive tumor.
  • Not suitable for or unwilling to undergo radical cystectomy.
  • ECOG performance status of 0, 1or 2.
  • Life expectancy ≥ 2 years.
  • Adequate hematologic and organ function.
  • Women of childbearing potential (WOCBP) must have a negative serum pregnancy test. WOCBP and male subjects agree to use adequate contraception.
  • Tumor tissue (archival or fresh) for biomarker analysis.

Exclusion Criteria:

  • • Subjects received TURBT or other surgical treatment for bladder lesions or pelvic radiotherapy or interventional therapy within 2 weeks prior to the first dose.
  • Previous treatment with: a) IL-15 or IL-2; b) immune checkpoint inhibitors (such as anti-PD-1 or PD-L1 antibodies), ADCs, chemotherapies, oncolytic viruses, BCG or other anti-tumor treatments, unless there is clear evidence of disease persistence/recurrence/progression after the above treatments and beyond 4 weeks prior to the first dose; c) Chinese herbal medicine treatment beyond 2 weeks prior to the first dose is allowed; d) A single immediate instillation of chemotherapy within 4 weeks prior to the first dose is allowed; e) intravesical instillation of mucosal protective agents (e.g., sodium hyaluronate) are allowed.
  • Subject is participating in an investigational drug or investigational device study.
  • Subjects have not recovered from AEs caused by previous anti-tumor treatment.
  • History/evidence of prior muscle-invasive, locally advanced, metastatic bladder cancer or upper urinary tract (kidney, renal pelvis, ureter) and prostatic urethral tumors; or evidence of Ta/T1/CIS urothelial transitional cell carcinoma outside the bladder (urethra, ureter, renal pelvis) during the screening period.
  • Patients with other malignancies within 5 years before the first dose.
  • Any active infection or urinary tract infection requiring systemic treatment by intravenous infusion within 2 weeks before the first dose.
  • Subjects with clinically significant cardiovascular disease within 6 months before the first dose of study treatment.
  • Known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS).
  • Active or chronic hepatitis B or hepatitis C infection.
  • Known or suspected active autoimmune diseases.
  • Concurrent use of any other anticancer therapy or chronic use of systemic corticosteroids at immunosuppressive doses (more than 10 mg/day prednisone or equivalent).
  • History of pneumonitis or interstitial lung disease or severe obstructive pulmonary disease that requires oral or intravenous steroids to help recover.
  • Known to be allergic or intolerant to study drugs, monoclonal antibodies, excipients; or allergic or intolerant to BCG (only for subjects receiving combined BCG therapy)
  • Subjects discontinued prior BCG treatment due to AEs such as toxemia, systemic infection, or urinary incontinence (only for subjects receiving combined BCG therapy).
  • History of allogeneic organ transplantation or graft-versus-host disease.
  • Any live vaccines within 4 weeks before the first dose.
  • Known mental illness or substance abuse that would interfere with trial complies.
  • Subject is pregnant or lactating, or is expected to become pregnant or parent a child during the planned study period.
  • Other conditions that investigators consider inappropriate for inclusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dose escalation-mono
BCG-unresponsive high-risk NMIBC, receiving SIM0237 monotherapy intravesically.
Drug: SIM0237
Several dose levels of SIM0237 will be administered as a single agent for evaluation
Drug: SIM0237
RD level of SIM0237 will be administered as a single agent for evaluation
Experimental: Dose escalation-combo
BCG-unresponsive high-risk NMIBC, receiving SIM0237 and BCG intravesically.
Drug: SIM0237 and BCG
Several dose levels of SIM0237 will be administered in combination with a fixed dose of BCG for evaluation
Drug: SIM0237 and BCG
RD level of SIM0237 will be administered in combination with a fixed dose of BCG for evaluation
Experimental: Dose expansion-Cohort 1
BCG-unresponsive CIS, receiving SIM0237 monotherapy intravesically.
Drug: SIM0237
Several dose levels of SIM0237 will be administered as a single agent for evaluation
Drug: SIM0237
RD level of SIM0237 will be administered as a single agent for evaluation
Experimental: Dose expansion-Cohort 3
BCG-unresponsive CIS, receiving SIM0237 and BCG intravesically.
Drug: SIM0237 and BCG
Several dose levels of SIM0237 will be administered in combination with a fixed dose of BCG for evaluation
Drug: SIM0237 and BCG
RD level of SIM0237 will be administered in combination with a fixed dose of BCG for evaluation
Experimental: Dose expansion-Cohort 4
BCG-unresponsive high-risk Ta or T1, receiving SIM0237 and BCG intravesically.
Drug: SIM0237 and BCG
Several dose levels of SIM0237 will be administered in combination with a fixed dose of BCG for evaluation
Drug: SIM0237 and BCG
RD level of SIM0237 will be administered in combination with a fixed dose of BCG for evaluation
Experimental: Dose expansion-Cohort 2
BCG-unresponsive high-risk Ta or T1, receiving SIM0237 monotherapy intravesically.
Drug: SIM0237
Several dose levels of SIM0237 will be administered as a single agent for evaluation
Drug: SIM0237
RD level of SIM0237 will be administered as a single agent for evaluation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dose escalation:Dose limited toxicity (DLT)
Time Frame: DLT observation period (up to 21 days)
DLT observation period (up to 21 days)
Dose escalation: Percentage of participants experiencing treatment-emergent adverse events (TEAEs)
Time Frame: through study completion, an average of 5 years
Incidence and severity of adverse events (AEs) and serious adverse events(SAEs),and lab abnormalities
through study completion, an average of 5 years
Dose escalation: Percentage of participants experiencing AE related dose interruptions and dose delays, dose intensity
Time Frame: through study completion, an average of 5 years
Occurrence of AE related dose interruptions, dose delays and dose intensity
through study completion, an average of 5 years
Dose expansion:Complete response (CR) rate at Month 3
Time Frame: through study completion, an average of 5 years
Complete response (CR) rate at of Cohort 1 and Cohort 3
through study completion, an average of 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu Simcere Pharmaceutical Co., Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shanghai Xianxiang Medical Technology Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 23, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 29, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 2, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SIM0237-102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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