OncoMatch/Clinical Trials/NCT06186414
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIM0237 Alone or in Combination with BCG in NMIBC
Is NCT06186414 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including SIM0237 and SIM0237 and BCG for non-muscle-invasive bladder cancer (nmibc).
Treatment: SIM0237 · SIM0237 and BCG · SIM0237 · SIM0237 and BCG — 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)
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Disease stage
Required: Stage CIS (TNM)
Excluded: Stage MUSCLE-INVASIVE, III, IV
Grade: high-grade
BCG-unresponsive CIS (with or without Ta or T1 disease) or BCG-unresponsive high-grade Ta or T1 disease
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: BCG — BCG-unresponsive
BCG-unresponsive CIS (with or without Ta or T1 disease) or histologically confirmed presence of BCG-unresponsive high-grade Ta or T1 disease
Cannot have received: IL-15
Previous treatment with: a) IL-15
Cannot have received: IL-2
Previous treatment with: b) IL-2
Cannot have received: immune checkpoint inhibitor
Exception: unless there is clear evidence of disease persistence/recurrence/progression after the above treatments and beyond 4 weeks prior to the first dose
Previous treatment with: 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
Cannot have received: antibody-drug conjugate
Exception: unless there is clear evidence of disease persistence/recurrence/progression after the above treatments and beyond 4 weeks prior to the first dose
Previous treatment with: 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
Cannot have received: chemotherapy
Exception: unless there is clear evidence of disease persistence/recurrence/progression after the above treatments and beyond 4 weeks prior to the first dose
Previous treatment with: 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
Cannot have received: oncolytic virus
Exception: unless there is clear evidence of disease persistence/recurrence/progression after the above treatments and beyond 4 weeks prior to the first dose
Previous treatment with: 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
Lab requirements
Blood counts
adequate hematologic function
Kidney function
adequate organ function
Liver function
adequate organ function
Adequate hematologic and organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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