Status:
TERMINATED
A Study of HS-196, an HSP90 Inhibitor-linked NIR Probe for Solid Malignancies
Lead Sponsor:
Herbert Lyerly
Conditions:
Solid Tumor
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
Brief Summary
HS-196 is near infrared red (NIR)-tethered HSP90 inhibitor for clinical imaging of selective tumor binding. HS-196 consists of a HSP90 inhibitor that binds competitively to the Hsp90 ATP binding domai...
Detailed Description
The product to be tested under this IND, HS-196, is a tumor imaging agent. Hsp90 (heat shock protein 90) is a chaperone protein that aids in the folding, stabilization, and degradation of cellular pr...
Eligibility Criteria
Inclusion
- For Dose escalation and recommended dose phases:
- Diagnosis of a solid malignancy, stage I-IV, with planned surgical resection or biopsy.
- For Expansion phase:
- Patients with mammographically detected breast nodules with planned surgical resection or biopsy.
- For All phases:
- 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, e.g., use of oral contraceptives with an additional barrier method (since the study drug may impair the effectiveness of oral contraceptives), double barrier methods (diaphragm with spermicidal gel or condoms with contraceptive foam), Depo-Provera, partner vasectomy, total abstinence, and willing to continue the effective contraception method for 30 days after the last dose of study drug;
- 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
- Serious chronic or acute illness considered by the P.I. to constitute an unwarranted high risk for investigational drug treatment.
- 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
Key Trial Info
Start Date :
August 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 7 2022
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03333031
Start Date
August 10 2018
End Date
September 7 2022
Last Update
June 18 2023
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710