Table 1.
Clinical trials of targeting cancer metabolism
| 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 | / |