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Table 1 Summary of the cGAS-STING agonist clinical trials

From: cGAS-STING pathway in cancer biotherapy

Cancer tpye Drug administration Phase NCT number Allocation Actual Enrollment Status Others References
Adult Solid Tumor ASA404 (i.v.) I NCT00003697 3 participants Recruiting [94]
Hormone Refractory Metastatic Prostate Cancer ASA404 II NCT00111618 Randomized 70 participants Completed Open Label [95]
Non-small Cell Lung Cancer ASA404 (i.v.) + Paclitaxel(i.v.) + Carboplatin(i.v.) I NCT00674102 15 participants Completed Open Label [96]
Locally Advanced and Metastatic NSCLC ASA404 (i.v.) + Paclitaxel(i.v.) + Carboplatin(i.v.) I/II NCT00832494 Randomized 105 participants Completed Open Label [97]
Refractory Tumors ASA404 (i.v.) I NCT00856336 Randomized 15 participants Completed Multicentre, Double blind [98]
Solid Tumors ASA404 I NCT00863733 Non-Randomized 63 participants Completed Open-label, Single Group Assignment [99]
Small Cell Lung Cancer ASA404 (i.v.) + Paclitaxel(i.v.) + Carboplatin(i.v.) II NCT01057342 17 participants Completed Open Label [100]
Advanced or Recurrent Solid Tumors ASA404 (i.v.) I NCT01285453 9 participants Completed Single Group Assignment [101]
Advanced/Metastatic Solid Tumors or Lymphomas ADU-S100(i.t.)+/−ipilimumab(i.v.) I NCT02675439 Non-Randomized 47 participants Active, not recruiting Open Label, Multicenter Study [102]
Advanced/metastatic solid tumors or lymphomas MK-1454(i.t.)+/−pembrolizumab(i.v.) I NCT03010176 Non-Randomized 235 participants Recruiting Open-label, Multicenter Study [103]
Advanced/Metastatic Solid Tumors and Lymphomas ADU-S100(i.t.) + PDR001(i.v.) Ib NCT03172936 Non-Randomized 106 participants Active, not recruiting Open Label, Multicenter Study [104]
Advanced Solid Tumors GSK3745417 (i.v.) +/−pembrolizumab (i.v.) I NCT03843359 Non-Randomized 300 participants Recruiting Open-label [105]
recurrent and Metastatic HNSCC ADU-S100(i.t.) + pembrolizumab(i.v.) II NCT03937141 33 participants Recruiting Open Label [106]
Advanced Solid Cancers BMS-986301+/−(Nivolumab+Ipilimumab) I NCT03956680 75 participants Recruiting Open Label [107]
Advanced Treatment-Refractory Malignancies I: IMSA101(i.t.)+/−ICI; IIA: IMSA101 + IO therapy; IIA: IMSA101 + ICI I/IIa NCT04020185 Non-Randomized 115 participants Recruiting Open-label, dose escalation, dose expansion [108]
Melanoma, HNSCC and Advanced Solid Tumor SB 11285(i.v.) + Nivolumab Ia/Ib NCT04096638 Non-Randomized 110 participants Recruiting multicenter, open-label, dose-escalation, cohort expansion study [109]
Non-muscle Invasive Bladder Cancer E7766(i.v.) I/Ib NCT04109092 Non-Randomized 120 participants Not yet recruiting Open-label, Multicenter [110]
Advanced Solid Tumors or Lymphomas E7766(i.t.) I/Ib NCT04144140 Non-Randomized 120 participants Not yet recruiting Open-Label, Multicenter [111]
Metastatic or unresectable, recurrent HNSCC pembrolizumab(i.t.)+/−MK-1454(i.v.) II NCT04220866 Randomized 200 participants Recruiting [112]
  1. Note: +/−, combination/alone
  2. Abbreviations: i.t. intratumoral injection, i.v. intravenous injection