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

NCT03906643 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: Pro00102188
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor

Keywords

tumor; verteporfin; HSP90 inhibitor

Outcome Measures

Primary Outcomes (1)

• Fluorescence

  Ratio of tumor to normal tissue fluorescence

  1 day

Secondary Outcomes (4)

• Number of AEs

  1 month

• Radiant Efficiency

  1 day

• HS-201 Localization

  1 week

• Maximum Plasma concentration Cmax

  1 week

Study Arms (1)

HS-201

EXPERIMENTAL

HS-201 will be administered intravenously as a single dose

Drug: HS-201

Interventions

HS-201 DRUG

HS-201 will be administered intravenously as a single dose

HS-201

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Herbert Lyerly: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Open label phase I study

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: April 8, 2019
• Study Start: July 15, 2020
• Primary Completion: January 15, 2023
• Study Completion: February 20, 2023
• Last Updated: December 20, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)