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WithdrawnNCT03906643Updated Dec 20, 2022

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

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 Withdrawn at 1 site in United States.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

Why this study was withdrawn
Funding exhausted
Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Solid Tumor

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Keywords

  • tumor
  • verteporfin
  • HSP90 inhibitor
03

In context

Neoplasms

9,617 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.

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Lead sponsor

Herbert Lyerly is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    HS-201

    HS-201 will be administered intravenously as a single dose

    Drug: HS-201

Interventions

  • DrugHS-201

    HS-201 will be administered intravenously as a single dose

06

What researchers measure

Primary outcomes

  1. Fluorescence

    Ratio of tumor to normal tissue fluorescence

    Time frame: 1 day

Secondary outcomes

  1. Number of AEs

    Safety of HS-201 administration in patients with malignancy

    Time frame: 1 month

  2. Radiant Efficiency

    The average radiant efficiency in resected tumors following HS-201 administration

    Time frame: 1 day

  3. HS-201 Localization

    Localization of the HS-196 by microscopy of tumor slices

    Time frame: 1 week

  4. Maximum Plasma concentration Cmax

    PK metrics of HS-201 when administered IV to patients

    Time frame: 1 week

07

Study locations

1 site
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03906643
Lead sponsor
Herbert Lyerly
Responsible party
Herbert Lyerly (Professor, Duke University) — Sponsor-investigator
First posted
Apr 8, 2019
Start date
Jul 15, 2020 (estimated)
Primary completion
Jan 15, 2023 (estimated)
Completion
Feb 20, 2023 (estimated)
Last update
Dec 20, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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