NCT02901483

A Study of PEP503 With Radiotherapy in Combination With Concurrent Chemotherapy for Patients With Head and Neck Cancer

Terminated Phase 1, PHASE2 Last updated 11 January 2022

What this trial tests

Phase 1, PHASE2 trial testing PEP503 in Head and Neck Squamous Cell Carcinoma in 12 participants. Terminated before completion.

Timeline

11 October 2016

Primary endpoint
17 August 2020

17 August 2020

Quick facts

Lead sponsor	PharmaEngine
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	11 October 2016
Primary completion	17 August 2020
Estimated completion	17 August 2020
Sites	1 location across Taiwan

Drugs / interventions tested

• PEP503 — full drug profile →
• Cisplatin (cisplatin) — full drug profile →
• Radiotherapy — full drug profile →

Conditions studied

• Head and Neck Squamous Cell Carcinoma — all drugs for Head and Neck Squamous Cell Carcinoma →

Sponsor

PharmaEngine — full company profile →

Who can join

20 and older, any sex, with Head and Neck Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

It's a prospective, open-label, single arm, nonrandomized study of PEP503 in head and neck squamous cell carcinoma (HNSCC) patients.

* Escalation portion (Phase 1b):A 3 + 3 dose escalation study design will be adopted in this phase to identify the recommended intratumor injection volumes of PEP503.
* Expansion portion (Phase 2): Following confirmation of the recommended volumes, 18 additional patients will be enrolled at the recommended volume level to evaluate for safety and efficacy.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Nanoparticles in the clinic: An update.
   Anselmo AC, Mitragotri S. · · 2019 · cited 976× · PMID 31572799 · DOI 10.1002/btm2.10143
2. Metal-based <i>NanoEnhancers</i> for Future Radiotherapy: Radiosensitizing and Synergistic Effects on Tumor Cells.
   Liu Y, Zhang P, Li F, Jin X, et al · · 2018 · cited 184× · PMID 29556359 · DOI 10.7150/thno.22172
3. Current Trends in Cancer Nanotheranostics: Metallic, Polymeric, and Lipid-Based Systems.
   Silva CO, Pinho JO, Lopes JM, Almeida AJ, et al · · 2019 · cited 101× · PMID 30625999 · DOI 10.3390/pharmaceutics11010022
4. Engineering nanoparticles to reprogram radiotherapy and immunotherapy: recent advances and future challenges.
   Jin J, Zhao Q. · · 2020 · cited 53× · PMID 32408880 · DOI 10.1186/s12951-020-00629-y
5. Emerging technologies for local cancer treatment.
   Chua CYX, Ho J, Demaria S, Ferrari M, et al · · 2020 · cited 48× · PMID 33072860 · DOI 10.1002/adtp.202000027
6. Understanding Nanoparticle Toxicity to Direct a Safe-by-Design Approach in Cancer Nanomedicine.
   Damasco JA, Ravi S, Perez JD, Hagaman DE, et al · · 2020 · cited 46× · PMID 33147800 · DOI 10.3390/nano10112186
7. The Promise of Nanoparticles-Based Radiotherapy in Cancer Treatment.
   Haque M, Shakil MS, Mahmud KM. · · 2023 · cited 45× · PMID 36980778 · DOI 10.3390/cancers15061892
8. The Dual Role of the Liver in Nanomedicine as an Actor in the Elimination of Nanostructures or a Therapeutic Target.
   Baboci L, Capolla S, Di Cintio F, Colombo F, et al · · 2020 · cited 37× · PMID 32184825 · DOI 10.1155/2020/4638192