A Phase 1, open-label trial of belzupacap sarotalocan (AU-011) to determine the feasibilityand safety of intratumoral injection with or without intramural injection in subjects withbladder cancer
A Phase 1, open-label trial of belzupacap sarotalocan (AU-011) to determine the feasibility
and safety of intratumoral injection with or without intramural injection in subjects with
Mechanism of Action
Virus-like drug conjugate (VDC) composed of the VLP as thetargeting component and the phthalocyanine dye as the cytotoxic payload
This purpose of this study is to obtain information on the safety and possible effectiveness (how well the drug works) of the study drug (bel-sar) when it is given as an injection in the wall of the bladder and within the bladder tumor. The distribution of the study drug will also be studied to confirm how far an injection of the study drug will travel in the wall of the bladder. A laser light may also be applied to the tumor as part of the procedure depending on the group you are enrolled in. The study will also evaluate how the body processes bel-sar and how well the procedure is tolerated.
- Confirmed diagnosis of NMIBC or MIBC. Biopsy or pathology must be obtained within 6 months prior to enrollment
- Have no evidence of metastatic disease
- Have a normal upper urinary tract
- Adequate bone marrow, renal, and hepatic function
Any additional malignancy that requires active treatment. Exceptions include:
- Basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy with evidence of remission for at least 1 year.
- In situ cervical cancer treated and with at least 1 year without recurrence.
- Any other subject felt appropriate by the Investigator upon discussion with trial’s Medical Monitor.
- Used an investigational drug or medical device within 30 days or 5 half-lives (whichever is longer) of Visit 1 or be concurrently enrolled in another investigational trial.
- Active bacterial, fungal, or viral infections – all prior infections must have resolved following optimal therapy and subject must be off all systemic anti-infective agents.
- Chronic active hepatitis B or C and HIV.
Mechanism of ActionVirus-like drug conjugate (VDC) composed of the VLP as thetargeting component and the phthalocyanine dye as the cytotoxic payload
Mechanism of ActionDK210 is an EGFR-targeting IL2/IL10
Mechanism of ActionBMS-986406 is an anti-LILRB2 antibody that reprograms the immune-suppressive macrophages which enhances anti-tumor immunity in the tumor microenvironment.
All participants must be anti-ILT4 naive.
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