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HS-201, an HSP90 Inhibitor-linked Verteporfin for Detection of Solid Malignancies

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ClinicalTrials.gov Identifier: NCT03906643
Recruitment Status : Recruiting
First Posted : April 8, 2019
Last Update Posted : July 23, 2020
Sponsor:
Information provided by (Responsible Party):
Herbert Lyerly, Duke University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: HS-201 Phase 1

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open label phase I study
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Phase I Study of HS-201, an HSP90 Inhibitor-linked Verteporfin for Detection of Solid Malignancies
Actual Study Start Date : July 15, 2020
Estimated Primary Completion Date : January 15, 2022
Estimated Study Completion Date : February 20, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Verteporfin

Arm Intervention/treatment
Experimental: HS-201
HS-201 will be administered intravenously as a single dose
Drug: HS-201
HS-201 will be administered intravenously as a single dose




Primary Outcome Measures :
  1. Fluorescence [ Time Frame: 1 day ]
    Ratio of tumor to normal tissue fluorescence


Secondary Outcome Measures :
  1. Number of AEs [ Time Frame: 1 month ]
    Safety of HS-201 administration in patients with malignancy

  2. Radiant Efficiency [ Time Frame: 1 day ]
    The average radiant efficiency in resected tumors following HS-201 administration

  3. HS-201 Localization [ Time Frame: 1 week ]
    Localization of the HS-196 by microscopy of tumor slices

  4. Maximum Plasma concentration Cmax [ Time Frame: 1 week ]
    PK metrics of HS-201 when administered IV to patients



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03906643


Contacts
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Contact: Michael A Morse, MD 919 684 5705 michael.morse@duke.edu
Contact: Amy Hobeika, PhD 919 684 6112 AMY.HOBEIKA@DUKE.EDU

Locations
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United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Michael Morse, MD    919-684-5705    michael.morse@duke.edu   
Sponsors and Collaborators
Herbert Lyerly
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Responsible Party: Herbert Lyerly, Professor, Duke University
ClinicalTrials.gov Identifier: NCT03906643    
Other Study ID Numbers: Pro00102188
First Posted: April 8, 2019    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Herbert Lyerly, Duke University:
tumor
verteporfin
HSP90 inhibitor
Additional relevant MeSH terms:
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Neoplasms