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

• Status: Recruiting
• Trial end date: 2023-02-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Herbert Lyerly
• Treatments: Verteporfin

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