{"entity":{"id":"actuate-1801","kind":"trial","name":"Actuate 1801 Part 3B (elraglusib)","aka":["actuate-1801","Actuate 1801","9-ING-41 in Patients With Advanced Cancers"],"tldr":"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.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT03678883","url":"https://clinicaltrials.gov/study/NCT03678883"},{"label":"Mahalingam et al., Nature Medicine 2026: elraglusib and chemotherapy in metastatic pancreatic ductal adenocarcinoma, randomised phase 2","url":"https://doi.org/10.1038/s41591-026-04327-4"},{"label":"Mahalingam et al., elraglusib randomised phase 2 (Nature Medicine 2026)","url":"https://doi.org/10.1038/s41591-026-04327-4"}],"tags":[],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["elraglusib","gemcitabine-nab-paclitaxel","gemcitabine","paclitaxel","doxorubicin","pegylated-liposomal-doxorubicin","lomustine","carboplatin"],"companies":["actuate-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-mahalingam-nat-med"],"journals":[],"dependsOn":[],"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."],"nct":"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.","started":"2019-01-04","startedType":"actual","yearReported":2025,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Elraglusib + gemcitabine-nab-paclitaxel","n":155,"value":10.1},{"name":"Gemcitabine-nab-paclitaxel","n":78,"value":7.2}],"hr":0.62,"ci":[0.46,0.84],"p":"0.01","source":"https://doi.org/10.1038/s41591-026-04327-4"},{"endpoint":"Overall survival at 1 year","primary":true,"unit":"%","arms":[{"name":"Elraglusib + gemcitabine-nab-paclitaxel","value":44.1},{"name":"Gemcitabine-nab-paclitaxel","value":22.3}],"source":"https://doi.org/10.1038/s41591-026-04327-4"},{"endpoint":"Overall survival (modified intention to treat)","primary":true,"unit":"months","arms":[{"name":"Elraglusib + gemcitabine/nab-paclitaxel","n":155,"value":10.1},{"name":"Gemcitabine/nab-paclitaxel","n":78,"value":7.2}],"hr":0.62,"ci":[0.46,0.84],"p":"0.01","source":"https://doi.org/10.1038/s41591-026-04327-4"},{"endpoint":"Overall survival at 1 year","primary":true,"unit":"%","arms":[{"name":"Elraglusib + gemcitabine/nab-paclitaxel","n":155,"value":44.1},{"name":"Gemcitabine/nab-paclitaxel","n":78,"value":22.3}],"source":"https://doi.org/10.1038/s41591-026-04327-4"}]},"route":"/trials/actuate-1801/","neighbours":{"cancer":[{"id":"metastatic-pdac","kind":"cancer","name":"Metastatic pancreatic ductal adenocarcinoma","route":"/cancers/metastatic-pdac/"},{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"carboplatin","kind":"drug","name":"Carboplatin","route":"/drugs/carboplatin/"},{"id":"doxorubicin","kind":"drug","name":"Doxorubicin","route":"/drugs/doxorubicin/"},{"id":"elraglusib","kind":"drug","name":"Elraglusib","route":"/drugs/elraglusib/"},{"id":"gemcitabine","kind":"drug","name":"Gemcitabine","route":"/drugs/gemcitabine/"},{"id":"gemcitabine-nab-paclitaxel","kind":"drug","name":"Gemcitabine + nab-paclitaxel","route":"/drugs/gemcitabine-nab-paclitaxel/"},{"id":"lomustine","kind":"drug","name":"Lomustine (CCNU)","route":"/drugs/lomustine/"},{"id":"paclitaxel","kind":"drug","name":"Paclitaxel / nab-paclitaxel","route":"/drugs/paclitaxel/"},{"id":"pegylated-liposomal-doxorubicin","kind":"drug","name":"Pegylated liposomal doxorubicin","route":"/drugs/pegylated-liposomal-doxorubicin/"}],"company":[{"id":"actuate-therapeutics","kind":"company","name":"Actuate Therapeutics","route":"/companies/actuate-therapeutics/"}],"paper":[{"id":"paper-mahalingam-nat-med","kind":"paper","name":"Elraglusib and chemotherapy in metastatic pancreatic ductal adenocarcinoma: a randomized controlled phase 2 trial","route":"/key-papers/paper-mahalingam-nat-med/"}]}}