Table 1 Clinical trials of targeting cancer metabolism

From: Cold and hot tumors: from molecular mechanisms to targeted therapy

Phase

ICIs Combination Therapy (immune checkpoint)

Doses

[n.treatment]

OS

PFS

Disease

Trial

Status

Ref.

III

Epacadostat (IDO1) + Pembrolizumab (PD-1)

epacadostat (100 mg) orally twice daily plus pembrolizumab (200 mg) intravenously every 3 weeks

[n = 354]

/

4.7 m

Unresectable or metastatic melanoma

NCT02752074

Completed

302

 

Placebo + Pembrolizumab (PD-1)

pembrolizumab (200 mg) intravenously every 3 weeks

[n = 352]

/

4.9 m

    

II

Oleclumab (CD73) + Durvalumab (PD-L1)

durvalumab (1,500 mg) every 4 weeks in combination with oleclumab (3,000 mg) every 2 weeks

[n = 21]

/

/

Resectable NSCLC

NCT03794544

Completed

303

 

Durvalumab (PD-L1)

durvalumab (1,500 mg) every 4 weeks

[n = 26]

/

/

    

II

ADI-PEG 20 (pegargiminase)

pegargiminase (320 IU/m2) (36.8 mg/m2) intramuscular every 1 weeks

[n = 22]

/

/

SCLC

NCT01266018

Terminated

304

I

DFMO (ODC)

Difluoromethylornithine (DFMO) (500-1500 mg/m2) every day

[n = 21]

/

/

NB

NCT01059071

Completed

305

I/II

L-NMMA (p-NOS) + Docetaxel

Docetaxel (two doses of 75 and 100 mg/m2) and L-NMMA (seven doses of 5, 7.5, 10, 12.5, 15, 17.5, and 20 mg/kg), L-NMMA was given intravenously on days 1 to 5 every 3 weeks, and docetaxel was given intravenously after L-NMMA on day 1 every 3 weeks. One cycle of treatment was defined as each 3-week regimen.

[n = 35]

/

/

TNBC

NCT02834403

Completed

306

I/II

Olutasidenib (mIDH1)

Olutasidenib was administered orally in doses of 150 mg once daily, 150 mg twice per day, and 300 mg once daily.

[n = 32]

/

/

AML

NCT02719574

Completed

307

 

Olutasidenib (mIDH1) + Azacitidine (mIDH1)

Olutasidenib was administered orally in doses of 150 mg once daily, 150 mg twice per day, and 300 mg once daily. Azacitidine (75 mg/m2) was administered subcutaneously or intravenously daily for 7 days on, 21 days off.

[n = 46]

/

/

    

III

Enasidenib (mIDH2)

enasidenib 100 mg per day orally (continuous); subcutaneous (SC) azacitidine 75 mg/m2 per day for 7 days per cycle; LDAC 20 mg twice-daily SC for 10 days per cycle; IDAC 0.5 to 1.5 g/m2 per day intravenous (IV) for 3 to 6 days per cycle; or BSC only

[n = 158]

6.5 m

/

AML

NCT02577406

Completed

308

 

Conventional care regimens (CCRs)

azacitidine, intermediate-dose cytarabine (IDAC), low-dose cytarabine (LDAC), or best supportive care (BSC) only

[n = 161]

6.2 m

/