A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIM0237 Alone or in Combination with BCG in NMIBC
NCT06186414
Phase
Phase 1
Recruitment status
Recruiting
Participants
Lead sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
Start date
2024-01-23
Number of sites
- 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)
- Short title
- A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIM0237 Alone or in Combination with BCG in NMIBC
- 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
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2030-12-01
- First posted
- 2024-01-02
- Registry last updated
- 2025-01-15
- Primary completion date
- 2027-01-01
- Start date
- 2024-01-23
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06186414
- ClinicalTrials.gov ID
- NCT06186414
- Registry record
- Open registry record
- Allocation
- Not randomised
- Model
- Sequential
- Purpose
- Treatment
- Masking
- No masking
Sources for study design
Dose escalation:Dose limited toxicity (DLT)
Timeframe: DLT observation period (up to 21 days)
Dose escalation: Percentage of participants experiencing treatment-emergent adverse events (TEAEs)
Timeframe: 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
Timeframe: 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
Timeframe: through study completion, an average of 5 years
Occurrence of AE related dose interruptions, dose delays and dose intensity
Sources for outcomes
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- 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.
- • 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.
Sources for eligibility
- Peking University Third HospitalBeijing, ChinaRecruiting
- Sun Yat-sen University Cancer CenterGuangzhou, ChinaRecruiting
- Harbin Medical University Cancer HospitalHaerbin, ChinaNot yet recruiting
- Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou UniversityZhengzhou, ChinaNot yet recruiting
- Renmin Hospital of Wuhan UniversityWuhan, ChinaNot yet recruiting
- Hunan Cancer HospitalChangsha, ChinaRecruiting
- Qilu Hospital of Shandong UniversityJinan, ChinaNot yet recruiting
- The Affiliated Hospital of Qingdao UniversityQingdao, ChinaRecruiting
- Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of MedicineShanghai, ChinaNot yet recruiting
- Fudan University Shanghai Cancer CenterShanghai, ChinaEnrolling by invitation
- First Hospital of Shanxi Medcial UniversityTaiyuan, ChinaNot yet recruiting
- West China Hospital of Sichuan UniversityChengdu, ChinaNot yet recruiting
- The Second Hospital of Tianjin Medical UniversityTianjin, ChinaRecruiting
- The First Affiliated Hospital of Wenzhou Medical UniversityWenzhou, ChinaNot yet recruiting
Sources for sites
Related records
Drugs (1)
Collaborators (1)
- Shanghai Xianxiang Medical Technology Co., Ltd.