近日，正大天晴在中美临床试验登记平台公示TIM3单抗TQB2618的I期临床研究方案，如下：
TQB2618注射液在晚期实体瘤患者中的安全性、耐受性及药代动力学I期临床试验（CTR20202150）
A Study to Evaluate the Tolerance and Pharmacokinetics of TQB2618 Injection in Subjects With Advanced Solid Tumors（NCT04623892）
该临床主要评价TQB2618注射液在晚期恶性实体瘤患者中的安全性和耐受性； 评价TQB2618注射液在晚期恶性实体瘤患者中的药代动力学特征、受体占位情况、免疫原性特征； 评价TQB2618注射液在晚期恶性实体瘤患者中的初步疗效； 探索TQB2618注射液治疗相关的生物标志物。首要研究终点为MTD；起始剂量1mg/人，剂量递增至1800mg/人，单次给药；3周期为一个给药周期，直至确定MTD或研究者认为无需继续剂量爬坡为止。
临床试验中心为浙江省肿瘤医院，计划招募50位受试者。
该临床公示于2020.10.29，预计将于2020.12.1正式开启。
| Reagent name (manufacturer) | Isotype | ClinicalTrials.gov identifier | Phase | Coblockade | Cancer type | Further reading |
| MGB453 (Novartis Pharmaceuticals) | IgG4 (S228P) | NCT02608268 | I/IIb | Anti-PD-1 | Advanced malignancies | 99 100 |
| MGB453 (Novartis Pharmaceuticals) | IgG4 (S228P) | NCT03066648 | I | Monotherapy or anti-PD-1 or Hypomethylating Agent (HMA)(decitabine or azacitidine) | AML, MDS | 14 99 100 |
| MGB453 (Novartis Pharmaceuticals) | IgG4 (S228P) | NCT03946670 | II | Randomized; HMA (decitabine or azacitidine) | MDS | 14 99 100 |
| TSR-022 (Tesaro) | IgG4 | NCT02817633 | I | Anti-PD-1 | Advanced solid tumors | 101–104 |
| TSR-022 (Tesaro) | IgG4 | NCT030680508 | II | Anti-PD-1 | Liver cancer | 101–103 |
| Sym023 (Symphogen A/S) | ? | NCT03489343 | I | Monotherapy | Solid tumors and lymphomas | 105 |
| Sym023 (Symphogen A/S) | ? | NCT03311412 | I | Anti-PD-1 | Solid tumors and lymphomas | 105 |
| BGBA425 (BeiGene) | IgG1 (variant, engineered to remove FcγR binding) | NCT03744468 | I | Anti-PD-1 | Solid tumors | 106 |
| R07121661 (Hoffmann-La Roche) | Bispecific antibody | NCT03708328 (development halted) | I | Targets both TIM-3 and PD-1 | Solid tumors metastatic melanoma, NSCLC | 107 |
| LY3321367 (Eli Lilly and Company) | ? | NCT03099109 (development halted) | Ia/Ib | Anti-PD-L1 | Advanced relapsed/refractory solid tumors | 108 |
| ICAGN02390 (Incyte Corporation) | IgG1k, N297A (Fc-engineered silent) | NCT03652077 | I | Monotherapy | Solid tumors | 109 |
| BMS-986258 (Bristol-Myers Squibb) | IgG1, silent | NCT03446040 | I | Anti-PD-1, human recombinant hyaluronidase | Advanced cancer | N/A |
AML, acute myelogenous leukemia; MDS, myelodysplastic syndrome; N/A, not applicable; NSCLC, non-small cell lung cancer; TIM-3, T-cell immunoglobulin and mucin domain 3.
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