Table 4 Anti-TIM-3 mAbs and associated clinical trials in solid tumors and leukemia
From: Targeting LAG-3, TIM-3, and TIGIT for cancer immunotherapy
Clinical trial identifier | Phase | Start date | Status | Cancer type (population, N) | Interventions and Combination | Target | Primary Outcome Measures | Secondary Outcome Measures |
|---|---|---|---|---|---|---|---|---|
NCT05738980 | Not Applicable | Feb 1, 2023 | Recruiting | HCC, N = 88 | Auto-anti-TIM-3-blocked RAK cells | TIM-3 | RFS | OS |
NCT03489343 | I | May 24, 2018 | Completed | Advanced Solid Tumor or Lymphomas, N = 24 | Sym023 | TIM-3 | AEs, DLTs | Immunogenicity, OR, SD, TTP |
NCT04623892 | I | Dec 01, 2020 | Unknown | Advanced Solid Tumors, N = 50 | TQB2618 | TIM-3 | MTD | Tmax, Cmax, ORR, PFS, DOR, DCR |
NCT04823624 | II | Sep 2021 | Unknown | Lower Risk MDS, N = 20 | MBG453 | TIM-3 | ORR, | TEAEs, PFS, OS |
NCT03652077 | I | Sep 24, 2018 | Completed | Select Advanced Malignancies, N = 40 | INCAGN02390 | TIM-3 | AEs, Tmax, PAD | Immunogenicity, ORR, DOR, DCR, PFS, Cmax, Tmax |
NCT05020912 | II | Dec 13, 2021 | Completed | HR/vHR MDS, N = 20 | MBG453 + azacytidine + venetoclax | TIM-3 | DLTs, CRR | CR, ORR, PFS, OS |
NCT03946670 | II | Jun 4, 2019 | Active, not recruiting | IM/H/VH-MDS, N = 127 | MBG453 + HMAs | TIM-3 | CRR, PFS | OS, LFS, ORR, DCR |
NCT04623216 | I/II | Sep 14, 2021 | Recruiting | AML/AML MRD + post-aHSCT, N = 59 | MBG453 + Azacitidine | TIM-3 | DLTs, CRR | grade III or IV aGvHD, cGvHD, ADA, Cmax, iR-AEs |
NCT04878432 | II | Mar 17, 2022 | Recruiting | IM/H/VH-MDS, N = 90 | MBG453 + HMA | TIM-3 | TEAEs, SAEs | CRR, OS, PFS, LFS, DOR |
NCT04266301 | III | Jun 8, 2020 | Active, not | IM/H/VH-MDS, CMML-2, N = 530 | MBG453 + Azacitidine | TIM-3 | OS | Safety, CR, etc. |
NCT04443751 | I | Sep 10, 2020 | Recruiting | R/R-AML, HR-MDS, N = 42 | SHR-1702 | TIM-3 | MTD, RP2D | Safety, PK, etc. |
NCT04150029 | II | Sep 1, 2020 | recruiting | ND-AML, N = 86 | MBG453 + HMA + Venetoclax | TIM-3 | Safety, DLTs CR rate | CR/CRi rate, OS, etc. |
NCT04812548 | II | May 31, 2021 | Not yet recruiting | HR-MDS, N = 76 | MBG453 + HMA + Venetoclax | TIM-3 | Safety, DLTs, CR rate | ORR, PFS, etc. |
CTR20201781 | III | Aug 6, 2020 | recruiting | HR-MDS, CMML-2, N = 100 | MBG453 + Azacitidine | TIM-3 | OS | Safety, CR, etc. |
NCT03680508 | II | Dec 19, 2019 | Recruiting | HCC, N = 42 | TSR-022 + TSR-042 | TIM-3, PD-1 | ORR | irRC, DOR, TTP PFS, OS |
NCT03311412 | I | Nov 20, 2017 | Completed | Advanced Solid Tumor or Lymphomas, N = 89 | Sym023 ± Sym021 | TIM-3, PD-1 | AEs, DLTs | Immunogenicity, OR, SD, TTP |
NCT03099109 | Ia/Ib | Apr 12, 2017 | Active, not recruiting | advanced relapsed/refractory solid tumors, N = 275 | LY3300054 ± LY3321367 | TIM-3, PD-L1 | DLTs | PK, ORR, PFS, DOR, TTP, DCR |
NCT02608268 | I-Ib/II | Nov 23, 2015 | Terminated | Advanced Malignancies, N = 252 | PDR001 ± MBG453 | TIM-3, PD-1 | Safety, ORR, DLTs | BOR, Cmax, DOR, OS, PFS, irRC |
NCT02817633 | I | Jul 8, 2016 | Recruiting | Advanced Solid Tumors, N = 475 | TSR-042 ± TSR-022 | TIM-3, PD-1 | DLTs, AEs, SAEs, TEAEs, irAEs, ORR | ORR, DOR, DCR, PFS, OS |
NCT04641871 | I | Oct 12, 2020 | Active, not recruiting | BTC, ESCC, N = 148 | Sym021 + Sym023 + irinotecan | TIM-3, PD-1 | ORR, AEs, SAEs | Cmax, Tmax, ORR, DOR, DCR, PFS, OS |
NCT05645315 | Ib | Apr 28, 2022 | Recruiting | Advanced Solid Tumors, N = 127 | TQB2618 + TQB2450 | TIM-3, PD-L1 | ORR, DLTs | Immunogenicity, PFS, OS, DCR, AEs |
NCT05563480 | II | Oct 27, 2022 | Recruiting | R/M NPC, N = 90 | TQB2618 + Penpulimab | TIM-3, PD-1 | MTD, ORR, PFS | OS, DCR, DOR, AEs, SAEs |
NCT03066648 | Ib | Jul 6, 2017 | Active, not recruiting | AML/HR-MDS, N = 241 | PDR001  ± MBG453 with HMA | TIM-3, PD-1 | AEs, SAEs, DLTs | ORR, DOR, DCR, PFS, TTP, Cmax, Tmax, Half-life |
NCT05834543 | Ib | May 2023 | Not yet recruiting | Advanced ESCC, N = 75 | TQB2618  + Penpulimab  + Chemotherapy | TIM-3, PD-1 | PFS, ORR | OS, DCR, DOR, AEs, SAEs |
NCT05451407 | I | Aug 9, 2022 | Not yet recruiting | Advanced Melanoma, N = 50 | TQB2618  + Toripalimab | TIM-3, PD-1 | DLTs, ORR | PFS, OS, DCR |
NCT04139902 | II | Jun 12, 2020 | Recruiting | operable melanoma, N = 56 | TSR-022  ± TSR-042 | TIM-3, PD-1 | MPR | PFS, OS, AEs, Frequency of Delays in Surgery |
NCT05400876 | Ib | Jun 9, 2022 | Recruiting | R/R Lymphoma, N = 92 | TQB2618  + Penpulimab | TIM-3, PD-1 | DLTs, ORR | CRR, DCR, DOR, PFS, OS, AEs |
NCT03940352 | I | Jun 24, 2019 | Active, not recruiting | AML, HR-MDS, N = 52 | MBG453  + HDM201 | TIM-3, p53-MDM2 | AEs, SAEs, DLTs | ORR, BOR, PFS |
NCT05783921 | I/II | Mar 2023 | Not yet recruiting | R/M-HNSCCs, N = 60 | TQB2618  + Penpulimab  + Chemotherapy | TIM-3, PD-1 | PFS, ORR | PFS, OS, DOR, DCR, CBR, AEs, SAEs |
NCT03961971 | I | Feb 18, 2020 | Active, not recruiting | Recurrent GBM, N = 16 | MBG453  + Spartalizumab  + Stereotactic radiosurgery SRS | TIM-3, PD-1 | SAEs | grade 3 or higher toxicity, PFS, OS, ORR |
NCT05367401 | I/II | Dec 20, 2024 | Not yet recruiting | Unfit ND-AML/HR-MDS/R/R-AML, N = 63 | MBG453  + Magrolimab  + Azacitidine | TIM-3, CD47 | DLTs, CR | ADA, Cmax, Time from first CR to relapse or death, CRR |
NCT04370704 | I/II | Jul 27, 2020 | Recruiting | Melanoma, N = 146 | INCAGN02385 INCAGN02390 + INCMGA00012 | TIM-3, PD-1, LAG-3 | TEAEs, ORR, DOR, DCR, PFS | ORR, DCR, PFS |
NCT04810611 | I | Jun 18, 2021 | Recruiting | LR-MDS, N = 90 | MBG453  ± NIS793  ± Canakinumab | TIM-3, TGF-β, IL-1β | DLTs, AEs, SAEs | BOR, TTP DOR, PFS, ORR |
NCT03744468 | I/II | Nov 13, 2018 | Recruiting | Advanced Solid Tumors, N = 358 | BGB-A425  + Tislelizumab  + LBL-007 | TIM-3, PD-1, LAG-3 | TEAEs, SAEs, MTD, ORR | DOR, DCR, PFS, PK, Cmax |
NCT04586244 | II | Jan 14, 2022 | Recruiting | Urothelial Carcinoma, N = 45 | INCAGN02390  + INCAGN02385  + Retifanlimab | TIM-3, LAG-3, PD-1 | CD8 + lymphocytes changes | TEAEs, pCR, MPR |
NCT05287113 | II | Nov 14, 2022 | Recruiting | PD-L1-Positive R/M-HNSCCs, N = 162 | Retifanlimab  + INCAGN02385  + INCAGN02390 | TIM-3, LAG-3, PD-1 | PFS | ORR, DOR, DCR, OS, TEAEs |
NCT03307785 | I | Oct 12, 2017 | Active, not recruiting | Advanced or Metastatic Cancer, N = 58 | TSR-022  + TSR-042  + Niraparib  + Chemotherapy | TIM-3, PD-L1, PARP1/2 | DLTs, AEs, TEAEs, STEAEs, AESIs | ORR, DCR, DOR, PFS, ADA, AUC, Cmax |
NCT04810611 | I | Jun 18, 2021 | Recruiting | LR-MDS, N = 90 | MBG453  ± NIS793  ± Canakinumab | TIM-3, TGF-β, IL-1β | DLTs, AEs, SAEs | BOR, TTP DOR, PFS, ORR |