Table 5.
Anti-TIGIT mAbs and associated clinical trials in cancer
| Clinical trial identifier | Phase | Start date | Status | Cancer type (population, N) | Interventions and Combination | Target | Primary Outcome Measures | Secondary Outcome Measures |
|---|---|---|---|---|---|---|---|---|
| NCT04353830 | I | May 22, 2020 | Complete | Advanced malignancy, N = 34 | IBI939 | TIGIT | AEs, DLTs | AUC, ADA |
| NCT04354246 | I | Mar 31, 2020 | Recruiting | Advanced cancer, N = 110 | COM902 | TIGIT | MTD, PK | ORR, CR |
| NCT04335253 | I/IIa | Feb 18, 2020 | Completed | Advanced cancer, N = 40 | EOS-448 | TIGIT | RP2D, DLTs | AUC, Cmax |
| NCT05394168 | I | Sep 15, 2022 | Not yet recruiting | Advanced/Metastatic Solid Tumor or Lymphoma, N = 20 | HLX53 | TIGIT | MTD, DLTs | ORR, Cmax |
| NCT03945253 | I | Aug 5, 2019 | complete | Advanced Solid Tumor, N = 6 | ASP8374 | TIGIT | AEs, DLTs | BOR |
| NCT04254107 | I | May 29, 2020 | Recruiting | NSCLC, GC, GEJ, N = 417 | SAE-TGT | TIGIT | AEs, DLTs | ORR, CR |
| NCT03563716 | II | Aug 10, 2018 | Active, not recruiting | NSCLC, N = 660 |
Tiragolumab + Tecentriq |
TIGIT PD-L1 | ORR, PFS | OS, DOR |
| NCT04294810 | III | Mar 4, 2020 | Recruiting | NSCLC, N = 136 |
Tiragolumab + Atezolizumab |
OS, PFS | DOR, ORR | |
| NCT05661578 | II | May 4, 2023 | Recruiting | PD-L1-selected Solid Tumor, N = 60 |
Tiragolumab + Mosunetuzumab or ± atezolizumab |
TIGIT PD-L1 | AEs | AUC, Cmax |
| NCT05315713 | I/II | May 10, 2022 | Active, not recruiting | NHL, FL, N = 118 |
Tiragolumab + Mosunetuzumab or ± Atezolizumab |
TIGIT CD20/CD3; TIGIT PD-L1 | ORR | CR, DOR |
| NCT04672369 | Ib | Jun 6, 2021 | Active, not recruiting | Advanced LCA, N = 42 |
IBI939 + Sintilimab |
TIGIT PD-1 | ORR | OR, PFS, DCR |
| NCT04672356 | I | Jan 25, 2021 | Active, not recruiting | Advanced LCA, N = 20 | AEs, RP2D | ORR, DCR | ||
| NCT02964013 | I | Dec 13, 2016 | Active, not recruiting | Neoplasms, N = 492 |
Vibostolimab + Pembrolizumab |
TIGIT PD-1 | DLTs, AEs | ORR, DLTs |
| NCT05014815 | II | Nov 16, 2021 | Active, not recruiting | Locally Advanced, Unresectable, or Metastatic NSCLC, NSCLC Stage IV, N = 270 |
Ociperlimab + Tislelizumab + Chemotherapy |
TIGIT PD-1 | PFS | ORR, DOR, OS |
| NCT04952597 | II | Jul 15, 2021 | Active, not recruiting | LS-SCLCr, N = 126 | PFS | CR, DOR, ORR | ||
| NCT04047862 | Ib | Aug 26, 2019 | Recruiting | Locally Advanced and Metastatic Solid Tumor, N = 542 |
Ociperlimab + Tislelizumab |
TIGIT PD-1 | DLTs, ORR, SAE | DOR, DCR |
| NCT05267054 | Ib/II | Apr 25, 2022 | Recruiting | rrDLBCL, Refractory DLBCL, N = 80 | Ociperlimab + Tislelizumab/rituximab | TIGIT PD-1/CD20 | AEs, RP2D | ORR, DOR |
| NCT05211895 | III | Feb 18, 2022 | Recruiting | NSCLC, N = 860 | Domvanalimab + Durvalumab | TIGIT PD-L1 | PFS, BICR | OS, ORR |
| NCT05130177 | II | Mar 16, 2022 | Recruiting | Melanoma, N = 26 |
Domvanalimab + Zimberelimab |
TIGIT PD-1 |
ORR, CR, PR | PFS, OS |
| NCT05568095 | III | Nov 21, 2022 | Recruiting | Advanced Upper Gastrointestinal Tract Adenocarcinoma, N = 970 |
Domvanalimab + Zimberelimab, Plus Chemotherapy |
TIGIT PD-1 | OS | PFS, ORR |
| NCT04826393 | I | Mar 9, 2022 | Active, not recruiting | GBM, N = 14 |
Domvanalimab + Cemiplimab |
TIGIT PD-1 | Tmax, MTD | PFS, OS |
| NCT03260322 | I | Sep 8, 2017 | Completed | Advanced Solid Tumor, N = 169 |
Domvanalimab + Pembrolizumab |
TIGIT PD-1 | DLTs, TEAEs | BOR, ORR |
| NCT05289492 | I/II | May 1, 2022 | Recruiting | MM, N = 162 |
EOS-448 + iberdomide ± dexamethasone |
TIGIT cereblon/GR | SAEs, AEs | PFS, TTR, DCR |
| NCT05026606 | II | Oct 1, 2021 | Active, not recruiting | Recurrent-OCCC, Recurrent Platinum-Resistant-FTC, N = 20 |
Etigilimab + Nivolumab |
TIGIT PD-1 | ORR | irPFS, DCR |
| NCT04761198 | Ib/II | Mar 23, 2021 | Active, not recruiting | Solid Tumor Adult, Advanced Solid Tumor, Metastatic Solid Tumor, N = 125 |
Etigilimab + Nivolumab |
TIGIT PD-1 | ORR | |
| NCT04570839 | I/II | Aug 31, 2020 | Active, not recruiting | OV, Solid Tumor, N = 100 |
BMS-986207 + COM701 and Nivolumab |
TIGIT PVRIG PD-1 | AEs, DLTs | ORR |
| NCT04585815 | Ib/II | Nov 10, 2020 | Active, not recruiting | Carcinoma, NSCLC, N = 24 |
BMS-986207 + COM701and Nivolumab |
TIGIT PD-1 VEGFR Kit PDGFR | DLTs, CR | DR, TTR |
| NCT05327530 | II | Aug 17, 2022 | Recruiting | Locally Advanced or Metastatic UC, N = 252 |
M6223 + Avelumab |
TIGIT PD-L1 | PFS, TEAEs | OS, OR |
ADA: Anti-drug Antibody, AEs: Adverse Events, AUC: Area Under the Plasma Concentration versus Time Curve, BOR: Best Overall Response, BICR: Blinded Independent Central Review, FTC: Carcinoma of Fallopian tube, CR: Complete Response, DLBCL: Diffuse Large B cell Lymphoma, DCR: Disease Control Rate, DLTs: Dose-limiting Toxicities,, DOR: Duration of Response, FL: Follicular Lymphoma, GC: Gastric Cancer, GEJ: Gastroesophageal Junction, GBM: Glioblastoma, iPFS: Immune-related Progression-Free Survival, LS-SCLCr: Limited Stage Small Cell Lung Cancer, LCA: Lung cancer, Cmax: Maximum Observed Serum Concentration, MM: Multiple Myeloma, MTD: Maximum Tolerated Dose, NHL: Non-Hodgkin Lymphoma, NSCLC: Non-small Cell Lung Cancer, OR: Objective Response, ORR: Objective Response Rate, OV: Ovarian Cancer, OCCC: Ovarian Clear Cell Carcinoma, OS: Overall Survival, PK: Pharmacokinetics, PFS: Progression-free Survival, RP2D: Recommended Phase 2 dose, rrDLBCL: Relapsed or Refractory Diffuse Large B cell Lymphoma, SAE: Serious Adverse Event, Tmax: Time of Maximum Concentration, TTR: Time to Response, TEAEs: Treatment-emergent Adverse Events, UC: Urothelial Carcinoma