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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