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

NCT03333031 | Terminated Phase 1 FDA Drug

• 1 other identifier: Pro00082272
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Solid Tumor

Keywords

cancer; imaging agent; HSP90

Outcome Measures

Primary Outcomes (1)

• Fluorescence

  Ratio of tumor to normal tissue fluorescence

  1 day

Secondary Outcomes (5)

• Number of AEs

  1 month

• Radiant Efficiency

  1 day

• HS-196 Localization

  1 day

• Maximum Plasma concentration Cmax

  1 week

• Area Under the Curve AUC

  1 week

Study Arms (1)

HS-196

EXPERIMENTAL

HS-196 will be administered intravenously as a single dose

Drug: HS-196

Interventions

HS-196 DRUG

HS-196 will be administered intravenously as a single dose

HS-196

Eligibility Criteria

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

You may qualify if:

• 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.

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.
• 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 Officials

• H. Kim Lyerly, MD

  Duke University

  PRINCIPAL INVESTIGATOR

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

Study Record Dates

• First Submitted: October 31, 2017
• First Posted: November 6, 2017
• Study Start: August 10, 2018
• Primary Completion: October 15, 2020
• Study Completion: September 7, 2022
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

US (1)