A Study of HS-196, an HSP90 Inhibitor-linked NIR Probe for Solid Malignancies

• Status: Recruiting
• Trial end date: 2023-08-10
• Target enrollment: 0
• Participant gender: All

Summary

HS-196 is near infrared red (NIR)-tethered HSP90 inhibitor for clinical imaging of selective tumor binding. HS-196 consists of a HSP90 inhibitor that binds competitively to the Hsp90 ATP binding domain connected by a linker to a contrast agent (near infrared (NIR) dye) that can be used for imaging. HS-196 can freely enter tumor cells to selectively bind Hsp90. Due to the the NIR dye, HS-196 accumulation in the malignant cells allows for specific visualization of tumors within the body.

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

Details

• Lead Sponsor: Duke University; Herbert Lyerly

Criteria

Inclusion Criteria:

For Dose escalation and recommended dose phases:

• Diagnosis of a solid malignancy, stage I-IV, with planned surgical resection or biopsy.

For Expansion phase:

• Patients with mammographically detected breast nodules with planned surgical resection or biopsy.

For All phases:

• 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, e.g., use of oral contraceptives with an additional barrier method (since the study drug may impair the effectiveness of oral contraceptives), double barrier methods (diaphragm with spermicidal gel or condoms with contraceptive foam), Depo-Provera, partner vasectomy, total abstinence, and willing to continue the effective contraception method for 30 days after the last dose of study drug;

• 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.

• 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