# HALO 109-301

Source: https://onco.cc/trials/halo-301/  
OnCo record `halo-301` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

HALO-301 was the phase 3 test of breaking down the dense stroma of pancreatic tumours with a hyaluronidase enzyme so chemotherapy could reach them; response rates went up but survival did not move, and the stroma-busting idea in this form was abandoned.

## Summary

HALO 109-301 randomised 494 patients (492 analysed: 327 PEGPH20, 165 placebo) whose tumours were hyaluronan-high on a companion assay. Median overall survival was 11.2 months with PEGPH20 against 11.5 months with placebo (hazard ratio 1.00, 95 percent confidence interval 0.80 to 1.27; p 0.97), progression-free survival 7.1 months in both arms (hazard ratio 0.97) and objective response 47 against 36 percent (ratio 1.29). Grade 3 or worse fatigue (16.0 against 9.6 percent), muscle spasms (6.5 against 0.6) and hyponatraemia (8.0 against 3.8) were commoner with PEGPH20. The trial recruited at 15 UK sites (Cambridge, Peterborough, the Beatson Glasgow, Sarah Cannon London, Edinburgh, Clatterbridge, Birmingham, Castle Hill, Coventry, Hammersmith and the Royal Marsden among them). The authors concluded the results did not support further development in metastatic disease and Halozyme closed the programme in 2019.

## Fields

- Kind: Trial
- Status: negative
- Last checked: 2026-09-24
- Also known as: HALO-301; HALO 301
- Registry id: NCT02715804
- Phase: 3
- Setting: Untreated hyaluronan-high metastatic pancreatic ductal adenocarcinoma at sites in 22 countries: pegvorhyaluronidase alfa or placebo with nab-paclitaxel plus gemcitabine, randomised 2 to 1, double-blind, with overall survival as the primary endpoint
- Sponsor: Halozyme Therapeutics
- Enrolled: 492
- Result: Median overall survival 11.2 months with PEGPH20 plus nab-paclitaxel and gemcitabine against 11.5 months with placebo (hazard ratio 1.00, 95 percent confidence interval 0.80 to 1.27; p 0.97); progression-free survival 7.1 months in both arms; response 47 against 36 percent.
- Outcomes: Overall survival: PEGPH20 + nab-paclitaxel + gemcitabine 11.2 months vs Placebo + nab-paclitaxel + gemcitabine 11.5 months, HR 1

## Notes

- UK sites (registry, 15): Addenbrooke's Cambridge; Peterborough; Beatson Glasgow; Sarah Cannon Research Institute UK London; Western General Edinburgh; Clatterbridge; Queen Elizabeth Birmingham; Castle Hill Cottingham; Coventry; Hammersmith; Royal Marsden Sutton and Chelsea, and others.

## Sources

- ClinicalTrials.gov NCT02715804: https://clinicaltrials.gov/study/NCT02715804
- Van Cutsem et al., HALO 109-301 (JCO 2020): https://doi.org/10.1200/JCO.20.00590

## Connected records

- cancers: [Metastatic pancreatic ductal adenocarcinoma](https://onco.cc/cancers/metastatic-pdac/), [Pancreatic ductal adenocarcinoma](https://onco.cc/cancers/pancreatic/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/)
- drugs: [Gemcitabine + nab-paclitaxel](https://onco.cc/drugs/gemcitabine-nab-paclitaxel/), [Nab-paclitaxel](https://onco.cc/drugs/nab-paclitaxel/), [Pegvorhyaluronidase alfa](https://onco.cc/drugs/pegvorhyaluronidase-alfa/)
- companies: [Halozyme Therapeutics](https://onco.cc/companies/halozyme/)
- terms: [Desmoplasia (tumour stroma)](https://onco.cc/terms/desmoplasia/), [Pancreatic cancer: the failed and stopped programmes and why](https://onco.cc/terms/pancreatic-failed-programmes/)
- people: [Eric Van Cutsem](https://onco.cc/people/eric-van-cutsem/)

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