A Phase 1 interventional study of HS-201 in Solid Tumor, sponsored by Herbert Lyerly. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2022-12-20.
Sponsored by Herbert Lyerly · Phase 1, Interventional, and Other
HS-201 is Verteporfin-tethered HSP90 inhibitor for clinical imaging of selective tumor binding. HS-201 consists of a HSP90 inhibitor that binds competitively to the Hsp90 ATP binding domain connected by a linker to a photosensitizing agent (verteporfin) that can be used for imaging. HS-201 can freely enter tumor cells to selectively bind Hsp90. Due to the the verteporfin, HS-201 accumulation in the malignant cells allows for specific visualization of tumors within the body and verteporfin may allow for photodynamic therapy of tumors.
The product to be tested in this study, HS-201, is a tumor imaging agent.
Hsp90 (heat shock protein 90) is a chaperone protein that aids in the folding, stabilization, and degradation of cellular proteins and is found in virtually all living organisms. Cancer cells in particular have high expression of Hsp90. Hsp90 has three structural domains including an N-terminal domain that contains an ATP binding site. Small molecule inhibitors of HSP90 (Hsp90i) can selectively and competitively to the Hsp90 ATP binding domain. HS-196 consists of a HSP90 inhibitor that binds competitively to the Hsp90 ATP binding domain connected by a linker to a photosensitzing agent (verteporfin) that can be used for imaging. HS-201 can freely enter tumor cells to selectively bind Hsp90. Due to the verteporfine, HS-201 accumulation in the malignant cells allows for specific visualization of tumors within the body.
HS-201 will be used in this investigation for the imaging of solid tumors The objectives of the study are to determine the dose of HS-201 that achieves the greatest ratio of tumor to normal tissue fluorescence in patients with malignancy, the safety of HS-201 administration in patients with malignancy, the average radiant efficiency in resected tumors following HS-201 administration, the localization of the HS-201 by microscopy of tumor slices, and the PK metrics of HS-201 when administered to patients.
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Exclusion Criteria:
HS-201 will be administered intravenously as a single dose
Drug: HS-201
HS-201 will be administered intravenously as a single dose
Fluorescence
Ratio of tumor to normal tissue fluorescence
Time frame: 1 day
Number of AEs
Safety of HS-201 administration in patients with malignancy
Time frame: 1 month
Radiant Efficiency
The average radiant efficiency in resected tumors following HS-201 administration
Time frame: 1 day
HS-201 Localization
Localization of the HS-196 by microscopy of tumor slices
Time frame: 1 week
Maximum Plasma concentration Cmax
PK metrics of HS-201 when administered IV to patients
Time frame: 1 week
Plan to share: No
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This study is withdrawn, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Herbert Lyerly