Non-Muscle-Invasive Bladder Cancer (NMIBC)Phase 1NCT06186414
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIM0237 Alone or in Combination with BCG in NMIBC
A Phase 1 study testing SIM0237 and SIM0237 and BCG in people with Non-Muscle-Invasive Bladder Cancer (NMIBC), run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 14 sites in China.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Muscle-Invasive Bladder Cancer (NMIBC)
- What is being tested?
- SIM0237 and SIM0237 and BCG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 14 sitesChina
- Study dates
- 23 Jan 2024to Dec 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
Who cannot join
- • 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.
Show all 20Show fewer
- 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.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
China14 sites, 14 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Shudong Zhang, Ph.D, shootong@163.com
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410031
Shusuan Jiang, Ph.D, Jiangshusuan@hnca.org.cn
- Not yet recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Qiang Dong, +86 18980601367, dqiang888@163.com
Ping Feng, 617130961@qq.com
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Zhuowei Liu, Ph.D, liuzhw@sysucc.org.cn
- Not yet recruiting
Harbin Medical University Cancer Hospital
Haerbin, Heilongjiang, 150000
Hui Chen, +86 13603612355, chenhui370@163.com
- Not yet recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Benkang Shi, +86 18560083917, bkshi68@163.com
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266071
Haitao Niu, Ph.D, niuht0532@126.com
Yu Cao, Ph.D, caoyu1767@126.com
- Not yet recruiting
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092
Xingang Cui, +86 13764346288, cuixingang@163.com
- Enrolling by invitation
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 201321
- Not yet recruiting
First Hospital of Shanxi Medcial University
Taiyuan, Shanxi, 30012
Xiaoming Cao, +86 13991205917, drcxm@126.com
- Recruiting
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300211
Hailong Hu, Ph.D, huhailong-yd2y@163.com
- Not yet recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325015
Zhixian Yu, +86 13957756729, yuZx515@163.com
- Not yet recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
Fan Cheng, +86 13307105017, 646064793@qq.com
- Not yet recruiting
Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University
Zhengzhou, Henan, 450003
Tiejun Yang, Ph.D, tiejunyang@126.com
About this study
Official title: 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)
Read the 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.
- Being tested
- SIM0237, SIM0237 and BCG
- Keywords
- NMIBC
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIM0237Drug
Several dose levels of SIM0237 will be administered as a single agent for evaluation
SIM0237 and BCGDrug
Several dose levels of SIM0237 will be administered in combination with a fixed dose of BCG for evaluation
SIM0237Drug
RD level of SIM0237 will be administered as a single agent for evaluation
SIM0237 and BCGDrug
RD level of SIM0237 will be administered in combination with a fixed dose of BCG for evaluation
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation-mono | Experimental | BCG-unresponsive high-risk NMIBC, receiving SIM0237 monotherapy intravesically. Receives: Drug: SIM0237 |
| Dose escalation-combo | Experimental | BCG-unresponsive high-risk NMIBC, receiving SIM0237 and BCG intravesically. Receives: Drug: SIM0237 and BCG |
| Dose expansion-Cohort 1 | Experimental | BCG-unresponsive CIS, receiving SIM0237 monotherapy intravesically. Receives: Drug: SIM0237 |
| Dose expansion-Cohort 3 | Experimental | BCG-unresponsive CIS, receiving SIM0237 and BCG intravesically. Receives: Drug: SIM0237 and BCG |
| Dose expansion-Cohort 4 | Experimental | BCG-unresponsive high-risk Ta or T1, receiving SIM0237 and BCG intravesically. Receives: Drug: SIM0237 and BCG |
| Dose expansion-Cohort 2 | Experimental | BCG-unresponsive high-risk Ta or T1, receiving SIM0237 monotherapy intravesically. Receives: Drug: SIM0237 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose escalation:Dose limited toxicity (DLT)
Measured: DLT observation period (up to 21 days)
Dose escalation: Percentage of participants experiencing treatment-emergent adverse events (TEAEs)
Incidence and severity of adverse events (AEs) and serious adverse events(SAEs),and lab abnormalities
Measured: through study completion, an average of 5 years
Dose expansion:Complete response (CR) rate at Month 3
Complete response (CR) rate at of Cohort 1 and Cohort 3
Measured: through study completion, an average of 5 years
Dose escalation: Percentage of participants experiencing AE related dose interruptions and dose delays, dose intensity
Occurrence of AE related dose interruptions, dose delays and dose intensity
Measured: through study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start23 Jan 2024
- Primary completionJan 2027 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Muscle-Invasive Bladder Cancer (NMIBC)Studies of the same condition, open and under way.
- More trials run by Jiangsu Simcere Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Xianxiang Medical Technology Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06186414
- Sponsor's protocol ID
- SIM0237-102
- Status last verified
- Jun 2024
- First submitted
- 7 Dec 2023
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06186414
- Acronym / sponsor ID
- SIM0237-102
- Keywords
- NMIBC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Xianxiang Medical Technology Co., Ltd.
- Study start
- 23 Jan 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 2 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Dose escalation-mono | Experimental | Drug: SIM0237BCG-unresponsive high-risk NMIBC, receiving SIM0237 monotherapy intravesically. |
| Dose escalation-combo | Experimental | Drug: SIM0237 and BCGBCG-unresponsive high-risk NMIBC, receiving SIM0237 and BCG intravesically. |
| Dose expansion-Cohort 1 | Experimental | Drug: SIM0237BCG-unresponsive CIS, receiving SIM0237 monotherapy intravesically. |
| Dose expansion-Cohort 3 | Experimental | Drug: SIM0237 and BCGBCG-unresponsive CIS, receiving SIM0237 and BCG intravesically. |
| Dose expansion-Cohort 4 | Experimental | Drug: SIM0237 and BCGBCG-unresponsive high-risk Ta or T1, receiving SIM0237 and BCG intravesically. |
| Dose expansion-Cohort 2 | Experimental | Drug: SIM0237BCG-unresponsive high-risk Ta or T1, receiving SIM0237 monotherapy intravesically. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (20 listed)
- • 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIM0237Several dose levels of SIM0237 will be administered as a single agent for evaluation | Drug | Dose escalation-mono |
| SIM0237 and BCGSeveral dose levels of SIM0237 will be administered in combination with a fixed dose of BCG for evaluation | Drug | Dose escalation-combo |
| SIM0237RD level of SIM0237 will be administered as a single agent for evaluation | Drug | Dose expansion-Cohort 1, Dose expansion-Cohort 2 |
| SIM0237 and BCGRD level of SIM0237 will be administered in combination with a fixed dose of BCG for evaluation | Drug | Dose expansion-Cohort 3, Dose expansion-Cohort 4 |
Primary outcome
Dose escalation:Dose limited toxicity (DLT)
Time frame: 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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Non-Muscle-Invasive Bladder Cancer (NMIBC)
RecruitingPhase 1
A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer
Non-muscle Invasive Bladder Cancer
Recruiting
Using Urine Tumor DNA to De-Intensify Surveillance in Non-Muscle Invasive Bladder Cancer
Non-muscle Invasive Bladder Cancer (NMIBC)
Active, not recruitingPhase 3
A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG)
Non-Muscle Invasive Bladder Neoplasms
RecruitingPhase 2
Disitamab Vedotin Plus Intravesical Mitomycin C in HER2-Expressing Intermediate- to High-Risk Non-Muscle-Invasive Bladder Cancer
Non-Muscle-Invasive Bladder Cancer (NMIBC)
RecruitingPhase 3
A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer
Non-Muscle Invasive Bladder Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SIM0237 and SIM0237 and BCG in people with Non-Muscle-Invasive Bladder Cancer (NMIBC), run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 14 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tammy Wu, Ph.D (13671827233, wutao@zaiming.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose escalation:Dose limited toxicity (DLT) (time frame: DLT observation period (up to 21 days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.