Solid TumorPhase 1NCT03906643
HS-201, an HSP90 Inhibitor-linked Verteporfin for Detection of Solid Malignancies
A Phase 1 study testing HS-201 in people with Solid Tumor, run by Herbert Lyerly at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- HS-201
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2020to 20 Feb 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: A Phase I Study of HS-201, an HSP90 Inhibitor-linked Verteporfin for Detection of Solid Malignancies
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.
- Conditions
- Solid Tumor
- Being tested
- HS-201
- Keywords
- tumor, verteporfin, HSP90 inhibitor
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-201Drug
HS-201 will be administered intravenously as a single dose
| Study group | Role | What they receive |
|---|---|---|
| HS-201 | Experimental | HS-201 will be administered intravenously as a single dose Receives: Drug: HS-201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluorescence
Ratio of tumor to normal tissue fluorescence
Measured: 1 day
Secondary outcomes (4)
Number of AEs
Safety of HS-201 administration in patients with malignancy
Measured: 1 month
Radiant Efficiency
The average radiant efficiency in resected tumors following HS-201 administration
Measured: 1 day
HS-201 Localization
Localization of the HS-196 by microscopy of tumor slices
Measured: 1 week
Maximum Plasma concentration Cmax
PK metrics of HS-201 when administered IV to patients
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start15 Jul 2020 (estimated)
- Primary completion15 Jan 2023 (estimated)
- Study completion20 Feb 2023 (estimated)
Why it stopped: Funding exhausted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label phase I study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herbert Lyerly
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Herbert Lyerly, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906643
- Sponsor's protocol ID
- Pro00102188
- Status last verified
- Dec 2022
- First submitted
- 5 Apr 2019
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of HS-201, an HSP90 Inhibitor-linked Verteporfin for Detection of Solid Malignancies
- ClinicalTrials.gov ID
- NCT03906643
- Acronym / sponsor ID
- Pro00102188
- Conditions
- Solid Tumor
- Keywords
- tumor, verteporfin, HSP90 inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding exhausted
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Herbert LyerlyUniversity, hospital or other
- Study start
- 15 Jul 2020 (estimated)
- Primary completion
- 15 Jan 2023 (estimated)
- Study completion
- 20 Feb 2023 (estimated)
- First posted
- 8 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label phase I study
| Arm | Type | Receives |
|---|---|---|
| HS-201 | Experimental | Drug: HS-201HS-201 will be administered intravenously as a single dose |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS-201HS-201 will be administered intravenously as a single dose | Drug | HS-201 |
Primary outcome
Fluorescence
Time frame: 1 day
Ratio of tumor to normal tissue fluorescence
4 secondary outcomes
Number of AEs
Time frame: 1 month
Radiant Efficiency
Time frame: 1 day
HS-201 Localization
Time frame: 1 week
Maximum Plasma concentration Cmax
Time frame: 1 week
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HS-201 in people with Solid Tumor, run by Herbert Lyerly at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluorescence (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.