Solid Tumor Clinical Trial
Official title:
A Phase I Study of HS-201, an HSP90 Inhibitor-linked Verteporfin for Detection of Solid Malignancies
Verified date | December 2022 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | February 20, 2023 |
Est. primary completion date | January 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - Diagnosis of a solid malignancy, stage I-IV. - 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: - Serious chronic or acute illness considered by the P.I. to constitute an unwarranted high risk for investigational drug treatment. - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Herbert Lyerly |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fluorescence | Ratio of tumor to normal tissue fluorescence | 1 day | |
Secondary | Number of AEs | Safety of HS-201 administration in patients with malignancy | 1 month | |
Secondary | Radiant Efficiency | The average radiant efficiency in resected tumors following HS-201 administration | 1 day | |
Secondary | HS-201 Localization | Localization of the HS-196 by microscopy of tumor slices | 1 week | |
Secondary | Maximum Plasma concentration Cmax | PK metrics of HS-201 when administered IV to patients | 1 week |
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