Clinical trial · Interventional
A Study to Evaluate Adze1.C in Participants With Metastatic Melanoma
A Phase 1, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Preliminary Efficacy of Intratumoural Adze1.C in Participants With Metastatic Melanoma
- 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)
This is Phase I, open label, multi-center clinical trial evaluating an investigational treatment, Adze1.C. Adze1.C is a type of oncolytic virus therapy for adults with advanced Melanoma that have not responded to standard treatments. Oncolytic viruses are designed to infect and destroy cancer cells and have the potential to stimulate the immune system to fight tumors. The purpose of this study is to assess preliminary efficacy, determine the safety of Adze1.C, how well it is tolerated, and to identify the highest dose that can be safely given.
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 |
|---|---|---|---|
| Metastatic Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adze1.C | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Adze1.C Dose Escalation
- description
- Participants will receive Adze1.C by intratumoural injection. All will begin with a low seroconversion dose (1 million viral particles (vp)), followed three weeks later by an escalation dose based on cohort assignment: Cohort 1: 100 million vp Cohort 2: 1 billion vp Cohort 3: 10 billion vp Doses are given every two weeks for up to 14 weeks. Dose escalation follows a 3+3 design to evaluate safety, tolerability, and early signs of efficacy.
- interventionNames
- Drug: Adze1.C
Primary outcomes (2)
- measure
- Incidence and severity of treatment-emergent adverse events (TEAEs)
- timeFrame
- From Day 1 (first dose) through Week 16 (end of treatment visit)
- description
- Safety will be assessed based on the frequency, nature, and severity of TEAEs, graded per CTCAE v5.0.
- measure
- Incidence of dose-limiting toxicities (DLTs)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female participants aged 18 years or older at Screening. * Histologically confirmed unresectable Stage IIIB to IV metastatic melanoma. * Refractory to, or unsuitable for, standard treatment options as determined by the investigator. * Not a suitable candidate for curative resection. * Presence of measurable disease per iRECIST (excluding irradiated lesions unless progression post-radiation is documented). * Presence of at least one injectable melanoma lesion and/or tumor-involved lymph node suitable for intratumoral administration. * ECOG performance status of 0 or 1 at Screening. * Stable visceral metastases and stable CNS metastases may be eligible if protocol-defined eligibility requirements are met. * Willing and able to provide written informed consent and comply with study procedures. Exclusion Criteria: * Uncontrolled intercurrent illness, including but not limited to: * Active systemic infection or fever ≥ 38°C within 5 days prior to Screening * Symptomatic congestive heart failure * NYHA Class III or IV heart failure * Unstable angina or arrhythmia * Leptomeningeal disease, active uncontrolled or symptomatic brain metastases, CNS haemorrhage, uncontrolled peri-tumoural oedema, or conditions associated with high risk of CNS inflammation * Psychiatric illness or social conditions that limit compliance * Visceral metastatic disease that is not clinically and radiographically stable or requires urgent medical intervention. * Immunocompromised status or known HIV infection with ongoing antiretroviral therapy. * Active or clinically significant liver disease, including: * Hepatitis B surface antigen (HBsAg) positive * Hepatitis C virus RNA positive * History of organ transplantation. * Prior treatment with adenovirus therapy. * Prior oncolytic virus treatment within 2 months of Screening. * Use of systemic immunosuppressants or other immune-modifying drugs must be discontinued 14 days prior to the first dose. * Use of cidofovir within 14 days of Adze1.C dosing. * Any other condition which, in the investigator's judgment, would make the participant inappropriate for the study.
References
Publications (0)
Data not yet available