# Actuate 1801 Part 3B (elraglusib)

Source: https://onco.cc/trials/actuate-1801/  
OnCo record `actuate-1801` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A randomised phase 2 found that adding the GSK-3 inhibitor elraglusib to standard chemotherapy lengthened survival in metastatic pancreatic cancer; a phase 3 is needed to confirm it.

## Summary

Part 3B of the Actuate 1801 study randomised patients with previously untreated metastatic pancreatic ductal adenocarcinoma to gemcitabine and nab-paclitaxel with or without elraglusib. The company reported improved overall survival and one-year survival with elraglusib. As a phase 2 result it is hypothesis-generating, and Actuate has said a confirmatory phase 3 is planned. The same registration, NCT03678883 (Actuate 1801), also covers the earlier dose-finding and expansion parts, in which elraglusib was given alone or with gemcitabine, doxorubicin, lomustine, carboplatin or paclitaxel to patients with refractory solid tumours or blood cancers.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-17
- Also known as: actuate-1801; Actuate 1801; 9-ING-41 in Patients With Advanced Cancers
- Registry id: NCT03678883
- Phase: 2
- Setting: Untreated metastatic pancreatic adenocarcinoma: gemcitabine and nab-paclitaxel with or without elraglusib
- Sponsor: Actuate Therapeutics
- Result: Overall survival longer with elraglusib in a randomised phase 2; confirmation pending.
- Outcomes: Overall survival: Elraglusib + gemcitabine-nab-paclitaxel 10.1 months vs Gemcitabine-nab-paclitaxel 7.2 months, HR 0.62; Overall survival at 1 year: Elraglusib + gemcitabine-nab-paclitaxel 44.1% vs Gemcitabine-nab-paclitaxel 22.3%; Overall survival (modified intention to treat): Elraglusib + gemcitabine/nab-paclitaxel 10.1 months vs Gemcitabine/nab-paclitaxel 7.2 months, HR 0.62; Overall survival at 1 year: Elraglusib + gemcitabine/nab-paclitaxel 44.1% vs Gemcitabine/nab-paclitaxel 22.3%

## Notes

- Primary paper (Nature Medicine 2026, Mahalingam et al.; data cut 27 April 2025): open-label international randomised phase 2, 2 to 1, 155 against 78 patients with untreated metastatic disease; median overall survival 10.1 against 7.2 months (hazard ratio 0.62, 0.46 to 0.84; p 0.01), one-year survival 44.1 against 22.3 percent; grade 3 or worse neutropenia 52.3 against 30.8 percent, anaemia 25.2 against 29.5, fatigue 16.8 against 5.1; baseline CXCL2 and TRAIL associated with benefit and intratumoral cytotoxic cells increased on treatment. Registry (NCT03678883): active but no longer recruiting, 350 participants (estimated), sites in the United States, Belgium, Canada, France, the Netherlands, Portugal and Spain, none in the UK. A phase 3 is planned.

## Sources

- ClinicalTrials.gov NCT03678883: https://clinicaltrials.gov/study/NCT03678883
- Mahalingam et al., Nature Medicine 2026: elraglusib and chemotherapy in metastatic pancreatic ductal adenocarcinoma, randomised phase 2: https://doi.org/10.1038/s41591-026-04327-4
- Mahalingam et al., elraglusib randomised phase 2 (Nature Medicine 2026): https://doi.org/10.1038/s41591-026-04327-4

## Connected records

- cancers: [Metastatic pancreatic ductal adenocarcinoma](https://onco.cc/cancers/metastatic-pdac/), [Pancreatic ductal adenocarcinoma](https://onco.cc/cancers/pancreatic/)
- technologies: [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- drugs: [Carboplatin](https://onco.cc/drugs/carboplatin/), [Doxorubicin](https://onco.cc/drugs/doxorubicin/), [Elraglusib](https://onco.cc/drugs/elraglusib/), [Gemcitabine](https://onco.cc/drugs/gemcitabine/), [Gemcitabine + nab-paclitaxel](https://onco.cc/drugs/gemcitabine-nab-paclitaxel/), [Lomustine (CCNU)](https://onco.cc/drugs/lomustine/), [Paclitaxel / nab-paclitaxel](https://onco.cc/drugs/paclitaxel/), [Pegylated liposomal doxorubicin](https://onco.cc/drugs/pegylated-liposomal-doxorubicin/)
- companies: [Actuate Therapeutics](https://onco.cc/companies/actuate-therapeutics/)
- key papers: [Elraglusib and chemotherapy in metastatic pancreatic ductal adenocarcinoma: a randomized controlled phase 2 trial](https://onco.cc/key-papers/paper-mahalingam-nat-med/)

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