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NCT06870994
Intratumoral Targeted Hyperthermia Therapy (THT) for Cutaneous Metastatic Melanoma
NA trial testing Targeted Hyperthermia Therapy in Cutaneous Metastatic Melanoma in 10 participants. Not yet recruiting.
30 June 2026
Quick facts
| Lead sponsor | Sona Nanotech Inc |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | device feasibility |
| Enrollment | 10 |
| Start date | 1 July 2025 |
| Primary completion | 30 June 2026 |
| Estimated completion | 30 June 2026 |
Drugs / interventions tested
- Targeted Hyperthermia Therapy
Conditions studied
- Cutaneous Metastatic Melanoma — all drugs for Cutaneous Metastatic Melanoma →
Sponsor
Sona Nanotech Inc
Who can join
16 and older, any sex, with Cutaneous Metastatic Melanoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This device phase I/II, first in human, early feasibility study (EFS), open-label, single-arm trial aims to evaluate the safety, tolerability, and preliminary efficacy of Gold Nanorod (GNR)-enabled sub-ablative targeted hyperthermia therapy (THT) in patients with unresectable stage 3C/3D/4M1 cutaneous metastatic malignant melanoma that have failed to respond to systemic checkpoint and localized intra-tumoral immunotherapy. The study will involve up to 10 participants with stable or progressive cutaneous and/or subcutaneous skin lesions (Immune Stable Disease (iSD) or Immune Confirmed/Unconfirmed Progressive Disease (iCPD/iUPD)). GNRs, when administered via intra-tumoral injection and activated by NIR light, generate localized heat through a process called THT. This approach selectively targets tumor cells while minimizing damage to surrounding healthy tissue. In this study, 10 participants will receive two THT treatments spaced 7 days apart. The primary objective of this study is to assess the safety and tolerability of THT treatment.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Recent advances in gold nanoparticle-based targeted photodynamic and photothermal cancer therapy.
Obalola AA, Abrahamse H, Dhilip Kumar SS. · · 2025 · cited 1× · PMID 41159015 · DOI 10.1039/d5na00767d -
Melanoma treatment in the era of nanotechnology and precision medicine.
da Cruz AF, Colella F, Grasso G, Onesto V, et al · · 2025 · PMID 41419864 · DOI 10.1186/s12951-025-03851-8
Verify or expand the search:
- PubMed search for NCT06870994
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Sona Nanotech Inc trials
Trials by the same sponsor.
- NCT05256589 — Clinical Evaluation of the SONA Saliva C-19 Rapid Self-Test for the Detection of COVID-19 · NA · completed
- NCT04877002 — Performance Study of SONA Saliva C-19 Rapid Test · NA · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06870994 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sona Nanotech Inc
- Last refreshed: 14 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06870994.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing