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正大天晴启动TIM3单抗TQB2618进入临床I期研究阶段


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)IsotypeClinicalTrials.gov identifierPhaseCoblockadeCancer typeFurther reading
MGB453 (Novartis Pharmaceuticals)IgG4 (S228P)NCT02608268I/IIbAnti-PD-1Advanced malignancies99 100
MGB453 (Novartis Pharmaceuticals)IgG4 (S228P)NCT03066648IMonotherapy or anti-PD-1 or Hypomethylating Agent (HMA)(decitabine or azacitidine)AML, MDS14 99 100
MGB453 (Novartis Pharmaceuticals)IgG4 (S228P)NCT03946670IIRandomized; HMA (decitabine or azacitidine)MDS14 99 100
TSR-022 (Tesaro)IgG4NCT02817633IAnti-PD-1Advanced solid tumors101–104
TSR-022 (Tesaro)IgG4NCT030680508IIAnti-PD-1Liver cancer101–103
Sym023 (Symphogen A/S)?NCT03489343IMonotherapySolid tumors and lymphomas105
Sym023 (Symphogen A/S)?NCT03311412IAnti-PD-1Solid tumors and lymphomas105
BGBA425 (BeiGene)IgG1 (variant, engineered to remove FcγR binding)NCT03744468IAnti-PD-1Solid tumors106
R07121661 (Hoffmann-La Roche)Bispecific antibodyNCT03708328 (development halted)ITargets both TIM-3 and PD-1Solid tumors metastatic melanoma, NSCLC107
LY3321367 (Eli Lilly and Company)?NCT03099109 (development halted)Ia/IbAnti-PD-L1Advanced relapsed/refractory solid tumors108
ICAGN02390 (Incyte Corporation)IgG1k, N297A (Fc-engineered silent)NCT03652077IMonotherapySolid tumors109
BMS-986258 (Bristol-Myers Squibb)IgG1, silentNCT03446040IAnti-PD-1, human recombinant hyaluronidaseAdvanced cancerN/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.

评论

匿名说…
慢慢跟上来了?
匿名说…
CTTQ是不是要开启“买买买”战略了,第一家会是谁
匿名说…
康方?