Table 1.
Current ongoing clinical trials for Tim-3-specific monoclonal antibodies or antagonist agents.
| Name of the compound | Mechanism of action | Study phase | Trial ID | Targeted population | Status |
|---|---|---|---|---|---|
| MBG453 + spartalizumab and stereotactic radiosurgery | Tim-3 inhibitor | Phase I | ClinicalTrials.gov NCT03961971 |
In patients with recurrent glioblastoma multiforme | Active, not recruiting |
| INCMGA00012 + INCAGN02385 and INCAGN02390 | Anti-PD-1, anti-LAG-3, anti-TIM-3 | Phases I and II | ClinicalTrials.gov NCT04370704 |
In patients with melanoma | Recruiting |
| TSR-042 | PD-1 inhibitor dostarlimab | Phase II | ClinicalTrials.gov NCT04139902 |
To test the effects of anti-PI-1 inhibitor (TSR-042) or anti-PD-1/anti-TIM-3 combination (TSR-042/TSR-022) in patients with operable melanoma | Recruiting |
| TSR-042 + TSR-022 | PD-1 inhibitor dostarlimab + Tim-3 inhibitor | ||||
| RO7121661 | PD-1/TIM-3 bispecific antibody | Phase I | ClinicalTrials.gov NCT03708328 |
In participants with advanced and/or metastatic solid tumors | Active, not recruiting |
| TSR-022 + TSR-042 | Anti-TIM-3 antibody, anti-PD-1 antibody | Phase II | ClinicalTrials.gov NCT03680508 |
In treating patients with locally advanced or metastatic liver cancer | Recruiting |
| Sym021 (monotherapy) | Anti-PD-1 | Phase I | ClinicalTrials.gov NCT03311412 |
In patients with locally advanced/unresectable or metastatic solid tumor malignancies or lymphomas that are refractory to available therapy or for which no standard therapy is available | Completed |
| Sym021 + Sym022 | Anti-PD-1 + anti-LAG-3 | ||||
| Sym021 + Sym023 | Anti-PD-1 + anti-TIM-3 | ||||
| Sym021 + Sym022 + Sym023 | Anti-PD-1 + anti-LAG-3 + anti-TIM-3 | ||||
| TSR-022 (conducted in two parts: part 1 consisting of dose escalation and part 2 dose expansion) | Anti-TIM-3 antibody | Phase I | ClinicalTrials.gov NCT02817633 |
In patients with advanced solid tumors (AMBER) | Recruiting |
| RO7121661 (compared with nivolumab) | PD1-TIM3 BsAb | Phase II | ClinicalTrials.gov NCT04785820 |
In patients with advanced or metastatic ESCC refractory or intolerant to fluoropyrimidine- or taxane- and platinum-based regimen | Recruiting |
| RO7247669 (compared with nivolumab) | PD1-LAG3 BsAb | ||||
| BGB-A425 + tislelizumab | Humanized IgG1-variant monoclonal antibody against TIM-3 + humanized IgG4-variant monoclonal antibody against PD-1 | Phases I and II | ClinicalTrials.gov NCT03744468 |
In locally advanced or metastatic solid tumors for phase I, dose escalation and phase II safety lead-in, HNSCC, NSCLC, and RCC participants for phase II | Recruiting |
| BGB-A425 + tislelizumab | |||||
| MBG453 (sabatolimab) | Anti-TIM-3 antibody | Phases I and II | ClinicalTrials.gov NCT04623216 |
In participants with AML/secondary AML who are in complete remission with positive measurable residual disease post-allogeneic hematopoietic stem cell transplantation (MRD+ post-aHSCT) | Recruiting |
| MBG453 (sabatolimab) + azacitidine | Anti-TIM-3 antibody + chemical analog of cytidine | ||||
| MBG453 (sabatolimab) + azacitidine | Anti-TIM-3 antibody + chemical analog of cytidine | Phase III | ClinicalTrials.gov NCT04266301 |
In adult subjects with intermediate, high, or very high-risk myelodysplastic syndrome (MDS) as per IPSS-R, or chronic myelomonocytic leukemia-2 (CMML-2) who have an indication for treatment with azacitidine in the first-line setting and are not eligible for intensive chemotherapy or HSCT according to medical judgment by the investigator | Active, not recruiting |
| HDM201 + MBG453 | Potential antineoplastic activity + anti-TIM-3 antibody Or |
Phase I | ClinicalTrials.gov NCT03940352 |
In subjects with AML or high-risk MDS | Active, not recruiting |
| For all subjects, TP53wt status must be characterized by, at a minimum, no mutations noted in exons 5, 6, 7, and 8 |
aHSCT, autologous hematopoietic stem cell transplantation; ESCC, esophageal squamous cell carcinoma; HNSCC, squamous cell carcinoma of the head and neck; HSCT, autologous hematopoietic stem cell transplantation; LAG-3, lymphocyte activation gene-3; RCC, renal cell carcinoma; TIM-3, T-cell immunoglobulin and mucin domain 3.