Clinical trial · Interventional
Safety, Pharmacodynamics (PD), Pharmacokinetics (PK) Study of SHP141 in 1A, 1B, or 2A Cutaneous T-Cell Lymphoma (CTCL)
A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Phase 1b Study to Assess the Safety, Pharmacodynamics and Pharmacokinetics of SHP 141, A Histone Deacetylase Inhibitor, Administered Topically Up to 28 Days to Patients With Stage IA, IB or IIA Cutaneous T-Cell Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to investigate the safety and tolerability of topical SHP141 applied directly to skin lesions in patients with Stage IA, IB, or IIA Cutaneous T-cell Lymphoma. This study will also investigate the effect of SHP141 on skin lesions in patients with Stage IA, IB, or IIA CTCL.
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 |
|---|---|---|---|
| Lymphoma, T-Cell, Cutaneous | Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| placebo for SHAPE (SHP-141) | Drug | — | UNRESOLVED |
| SHAPE (SHP-141) 0.1% BID | Drug | — | UNRESOLVED |
| SHAPE (SHP-141) 0.5% BID | Drug | — | UNRESOLVED |
| SHAPE (SHP-141) 1.0% BID | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- PLACEBO_COMPARATOR
- label
- placebo for SHAPE (SHP-141)
- description
- placebo for SHAPE (SHHP-141) topical gelled solution
- interventionNames
- Drug: placebo for SHAPE (SHP-141)
- type
- EXPERIMENTAL
- label
- SHAPE (SHP-141) 0.1%BID
- description
- SHAPE (SHP-141) topical gelled solution at 0.1% concentration twice weekly
- interventionNames
- Drug: SHAPE (SHP-141) 0.1% BID
- type
- EXPERIMENTAL
- label
- SHAPE (SHP-141) 0.5% BID
- description
- SHAPE (SHP-141) topical gelled solution at 0.5% concentration twice weekly
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histopathologically confirmed CTCL; a documented verifiable biopsy report is required. * Documented clinical Stage IA, IB, or IIA CTCL. * Skin lesion involvement of at least 3% of BSA accessible for topical application of study drug and biopsy. * ECOG performance status of 0-2. Exclusion Criteria: * CTCL with histologic evidence of folliculotropic variant or large cell transformed CTCL. * Severe pruritus requiring systemic or topical treatment. * Palpable lymph node ≥1.5 cm in diameter (unless the lymph node has been biopsied and has been designated as Stage IA-IIA disease). * Coexistent second malignancy or history of prior solid organ malignancy within previous 5 years (excluding basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix (CIN 3), papillary or follicular thyroid cancer that has been treated curatively, or prostate cancer that has been treated curatively). * Any prior history of a hematologic malignancy (other than CTCL). * History of or current major renal, hepatic, gastrointestinal, pulmonary, cardiovascular, genito-urinary or hematological disease, CNS disorders, infectious disease or coagulation disorders as determined by the Investigator. * Evidence of active Hepatitis B or C or HIV. * Circulating atypical cells \>5%
References
Publications (0)
Data not yet available