Table 3.
Anti-Tim-3 clinical trials.
| Reagent name (manufacturer) | ClinicalTrials.gov Identifier | Phase | Cancer type | Co-blockade | Primary outcome | Secondary outcome | Recruitment status |
|---|---|---|---|---|---|---|---|
| Sym023 (Symphogen A/S) | NCT03489343 | I | Solid tumors and lymphoma | Monotherapy | MTD; RP2D | Immunogenicity; ORR; SD; TTP | Completed |
| Sym023 (Symphogen A/S) | NCT03311412 | I | Solid tumors and lymphoma | Anti-PD-1 (Sym021) | Treatment emergent AEs meeting DLT criteria (safety and tolerability) | Immunogenicity; ORR; SD; TTP; maximum concentration | Recruiting |
| TSR-022 (Tesaro) | NCT03680508 | II | Locally advanced or metastatic liver cancer | Anti-PD-1 (TSR-042) | ORR | DOR; TTP; PFS; alpha-fetoprotein (AFP) response | Recruiting |
| TSR-022 (Tesaro) | NCT02817633 | I | Advanced solid tumors | Anti-PD-1 (TSR-042) | DLT; AEs; ORR | DOR; DCR; OS; t1/2 of TSR-022 in combination with TSR-042 | Recruiting |
| TSR-022 (Tesaro) | NCT04139902 | II | Melanoma | Anti-PD-1 (TSR-042) | MPR | AEs; relapse-free survival; OS; frequency of cancellations of surgery | Recruiting |
| LY3321367 (Eli Lilly and Company) | NCT03099109 | Ia/Ib | Advanced relapsed/refractory solid tumors | Anti-PD-1 (LY3300054) | Number of participants with DLTs | Cmax of LY3321367; Cmax of LY3321367 in combination with LY3300054; PFS; DOR; TTR; DCR | Active, no recruiting |
| RO7247669 (Hoffmann-La Roche) | NCT04785820 | II | Advanced or metastatic esophageal squamous cell carcinoma | Targets both Tim-3 and PD-1 | OS | AEs; DCR; PFS; serum concentrations of RO7247669; CD8+Tim-3+ | Recruiting |
| AZD7789 (AstraZeneca) | NCT04931654 | I/IIa | NSCLC | Targets both Tim-3 and PD-1 | AEs; DLT; preliminary anti-tumor activity of AZD7789 | ORR; DCR; DOR; OS; Cmax; immunogenicity; clearance; | Not yet recruiting |
| MBG453 (Novartis Pharmaceuticals) | NCT03961971 | I | Glioblastoma multiforme | Anti-PD-1 (spartalizumab) | Number of participants with serious AEs | PFS; OS; ORR | Recruiting |
| MBG453 (Novartis Pharmaceuticals) | NCT04823624 | II | Myelodysplastic syndromes | Monotherapy | ORR | OS; PFS; TTP; DOR | Not yet recruiting |
| MBG453 (Novartis Pharmaceuticals) | NCT02608268 | I-Ib/II | Advanced malignancies | Anti-PD-1 (PDR001) | Safety and tolerability; ORR; DLTs | BOR; presence and concentration of anti-MBG453 antibodies; Cmax; OS; DOR; PFS; | Active, not recruiting |
| MBG453 (Novartis Pharmaceuticals) | NCT03946670 | II | Myelodysplastic syndromes | Randomized; HMA (decitabine or azacitidine) | CR rate; PFS | OS; event free survival; leukemia-free survival; response rate; time to CR | Active, not recruiting |
| INCAGN02390 (Incyte Corporation) | NCT03652077 | I | Advanced malignancies | Monotherapy | Number of treatment-emergent adverse events; maximum tolerated dose of INCAGN02390 | ORR; DOR; DCR; PFS; immunogenicity; level of binding of INCAGN02390 to Tim-3 | Active, not recruiting |
| BMS-986258 (Bristol-Myers Squibb) | NCT03446040 | I-II | Advanced cancer | Anti-PD-1 (Nivolumab), human recombinant hyaluronidase | AEs; serious AEs; incidence of AEs leading to discontinuation or to death | ORR; PFS; Cmax; DOR; incidence of anti-drug antibody to BMS-986258 | Recruiting |
| RO7121661 (Hoffmann-La Roche) | NCT03708328 | I | Solid tumors, metastatic melanoma; NSCLC | Targets both Tim-3 and PD-1 | DLT; ORR; DCR; DOR; PFS | Cmax; total clearance; Volume of Distribution at Steady State; terminal half-life | Active, not recruiting |
| BGB-A425 (BeiGene) | NCT03744468 | I | Solid tumors | Anti-PD-1 (Tislelizumab) | Safety and tolerability (MTD, RP2D and MAD) | DOR; DCR; PFS; Cmax; terminal half-life; immunogenicity | Recruiting |
Abbreviations: MTD, maximum tolerated dose; RP2D, recommended phase 2 dose; OR, objective response rate; SD, stable disease; TTP, time to progression; DLT, dose-limiting toxicities; AE, adverse event; PFS, progression free survival; DOR, duration of response; DCR, disease control rate; MPR, major pathologic response; Cmax, maximum concentration; BOR, best overall response; NSCLC, non-small cell lung cancer; MAD, maximum administered dose.