NCT02910882: HALO-IST

PEGPH20 Plus Gemcitabine With Radiotherapy in Patients With Localized, Unresectable Pancreatic Cancer

Terminated Phase 2 Last updated 11 April 2019

What this trial tests

Phase 2 trial testing PEGylated Recombinant Human Hyaluronidase (PEGPH20) in Pancreatic Adenocarcinoma Non-resectable in 4 participants. Terminated before completion.

Timeline

3 January 2017

Primary endpoint
31 August 2018

31 August 2018

Quick facts

Lead sponsor	Scripps Health
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	4
Start date	3 January 2017
Primary completion	31 August 2018
Estimated completion	31 August 2018
Sites	1 location across United States

Drugs / interventions tested

• PEGylated Recombinant Human Hyaluronidase (PEGPH20) — full drug profile →
• Gemcitabine (gemcitabine) — full drug profile →
• Radiation

Conditions studied

• Pancreatic Adenocarcinoma Non-resectable — all drugs for Pancreatic Adenocarcinoma Non-resectable →

Sponsor

Scripps Health — full company profile →

Who can join

Under 90, any sex, with Pancreatic Adenocarcinoma Non-resectable. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a single arm phase II trial assessing the potential activity of combination PEGPH20 plus Gemcitabine with radiotherapy in ten patients with localized, unresectable pancreatic adenocarcinoma.

Publications & conference data

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

1. The Extracellular Matrix and Pancreatic Cancer: A Complex Relationship.
   Weniger M, Honselmann KC, Liss AS. · · 2018 · cited 208× · PMID 30200666 · DOI 10.3390/cancers10090316
2. Targeting the tumor stroma for cancer therapy.
   Xu M, Zhang T, Xia R, Wei Y, et al · · 2022 · cited 195× · PMID 36324128 · DOI 10.1186/s12943-022-01670-1
3. CSF1R⁺ Macrophages Sustain Pancreatic Tumor Growth through T Cell Suppression and Maintenance of Key Gene Programs that Define the Squamous Subtype.
   Candido JB, Morton JP, Bailey P, Campbell AD, et al · · 2018 · cited 182× · PMID 29719257 · DOI 10.1016/j.celrep.2018.03.131
4. Recent advances in hyaluronic acid-decorated nanocarriers for targeted cancer therapy.
   Wickens JM, Alsaab HO, Kesharwani P, Bhise K, et al · · 2017 · cited 134× · PMID 28017836 · DOI 10.1016/j.drudis.2016.12.009
5. Therapeutic challenges and current immunomodulatory strategies in targeting the immunosuppressive pancreatic tumor microenvironment.
   Looi CK, Chung FF, Leong CO, Wong SF, et al · · 2019 · cited 131× · PMID 30987642 · DOI 10.1186/s13046-019-1153-8
6. Collagen Complexity Spatially Defines Microregions of Total Tissue Pressure in Pancreatic Cancer.
   Nieskoski MD, Marra K, Gunn JR, Hoopes PJ, et al · · 2017 · cited 56× · PMID 28855644 · DOI 10.1038/s41598-017-10671-w
7. Targeting the complexity of Src signalling in the tumour microenvironment of pancreatic cancer: from mechanism to therapy.
   Parkin A, Man J, Timpson P, Pajic M. · · 2019 · cited 40× · PMID 31330086 · DOI 10.1111/febs.15011
8. Enhancing the Efficacy of CAR T Cells in the Tumor Microenvironment of Pancreatic Cancer.
   Henze J, Tacke F, Hardt O, Alves F, et al · · 2020 · cited 28× · PMID 32481570 · DOI 10.3390/cancers12061389