Clinical trial · Interventional
A Study of ADH-1 in Combination With Normothermic Isolated Limb Infusion of Melphalan
An Open-Label, Multicenter, Phase 1/2 Dose Escalation Study to Evaluate Safety, Tolerability and Anti-tumor Activity of Systemic ADH-1 in Combination With Normothermic Isolated Limb Infusion of Melphalan in Subjects With Locally Advanced In-Transit Malignant Melanoma (Adherex Protocol Number AHX-01-007).
- 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)
N-cadherin, a protein involved in blood vessel cell binding and on the surface of many tumor cells, is increased as cancer progresses. ADH-1 blocks N-cadherin. This study will test the safety and effects of the combination ADH-1 with Normothermic Isolated Limb Infusion of Melphalan in subjects with locally advanced malignant melanoma.
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 |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ADH-1 | Drug | — | UNRESOLVED |
| melphalan | Drug | Melphalan | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To tabulate the Best Overall Response according to unconfirmed RECIST, modified for cutaneous lesions
- timeFrame
- By Week 12
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed written informed consent * Male and female patients \> or = 18 years of age with diagnosis of melanoma for which treatment with Normothermic Isolated Limb Infusion (ILI) of melphalan would be appropriate * Measurable disease * Disease site(s) must be distal to the planned site of tourniquet placement * Available for immunohistochemical testing of N-cadherin expression tumor tissue * Adequate performance status and organ function, as evidenced by hematological and biochemical blood testing and ECG Exclusion Criteria: * Receipt of ADH-1 prior to this clinical study (prior melphalan via ILI, is okay) * Stage IV melanoma * Chemotherapy, radiotherapy, or any other investigational drug within 4 weeks before study entry * History of tumors that have shown clinically significant evidence of active bleeding within 12 weeks before study entry * Stroke, major surgery, or other major tissue injury within 4 weeks before study entry * Uncontrolled congestive heart failure, coronary artery disease, or life threatening arrhythmias; myocardial infarction within 12 months; significant electrocardiogram (ECG) abnormalities * Allergic reaction to any therapeutic peptide or to melphalan
References
Publications (0)
Data not yet available