Clinical trial · Interventional
HS-201, an HSP90 Inhibitor-linked Verteporfin for Detection of Solid Malignancies
A Phase I Study of HS-201, an HSP90 Inhibitor-linked Verteporfin for Detection of Solid Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding exhausted
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HS-201 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HS-201
- description
- HS-201 will be administered intravenously as a single dose
- interventionNames
- Drug: HS-201
Primary outcomes (1)
- measure
- Fluorescence
- timeFrame
- 1 day
- description
- Ratio of tumor to normal tissue fluorescence
Secondary outcomes (4)
- measure
- Number of AEs
- timeFrame
- 1 month
- description
- Safety of HS-201 administration in patients with malignancy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available