HS-201, an HSP90 Inhibitor-linked Verteporfin for Detection of Solid Malignancies
NCT ID: NCT03906643
Last Updated: 2022-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2020-07-15
2023-02-20
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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HS-201
HS-201 will be administered intravenously as a single dose
HS-201
HS-201 will be administered intravenously as a single dose
Interventions
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HS-201
HS-201 will be administered intravenously as a single dose
Eligibility Criteria
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Inclusion Criteria
* Planned surgical resection or biopsy of a malignancy
* ECOG 0 or 1
* Estimated life expectancy \> 3 months
* Age ≥ 18 years
* Adequate hematologic function, with WBC ≥ 3000/microliter, hemoglobin ≥ 9 g/dL (it is acceptable to have had prior transfusion), platelets ≥ 75,000/microliter; PT-INR \<1.5, PTT \<1.5X ULN
* Adequate renal and hepatic function, with serum creatinine \< 1.5 mg/dL, bilirubin \< 1.5 mg/dL (except for Gilbert's syndrome which will allow bilirubin ≤ 2.0 mg/dL), ALT and AST ≤ 2.5 x upper limit of normal or if liver metastases are present \< 5 x upper limit of normal.
* Female patients must be of non-child-bearing potential or use effective contraception
* Ability to understand and provide signed informed consent that fulfills Institutional Review Board's guidelines.
* Ability to return to Duke University Medical Center for adequate follow-up, as required by this protocol.
Exclusion Criteria
* Patients with porphyria or a known hypersensitivity to any component of this preparation are excluded.
* Medical or psychological impediment to probable compliance with the protocol.
* Asthma under medical management
* Uncontrolled high blood pressure
* Presence of a known active acute or chronic infection including HIV or viral hepatitis (Hepatitis B and C)).
* Pregnant or nursing women
18 Years
99 Years
ALL
No
Sponsors
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Herbert Lyerly
OTHER
Responsible Party
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Herbert Lyerly
Professor
Locations
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Duke University Medical Center
Durham, North Carolina, United States
Countries
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Other Identifiers
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Pro00102188
Identifier Type: -
Identifier Source: org_study_id