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更新于：2026-11-09
TQB-2102
更新于：2026-11-09
概要
基本信息
药物类型 ADC |
别名 TQB 2102、TQB-2102 |
作用方式 拮抗剂、抑制剂 |
作用机制 HER2拮抗剂(受体蛋白酪氨酸激酶 erbB-2拮抗剂)、TOP1抑制剂(DNA拓扑异构酶I抑制剂)、ADCC(抗体依赖的细胞毒作用) |
在研适应症 |
非在研适应症- |
非在研机构- |
最高研发阶段申请上市 |
首次获批日期- |
最高研发阶段(中国)申请上市 |
特殊审评突破性疗法 (中国)、优先审评 (中国) |
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18
项与 TQB-2102 相关的临床试验NCT07512583
Phase Ib/II Clinical Trial of TQB2930 Injection in Combination With TQB2102 for Injection in Patients With HER2-Expressing Advanced Solid Tumors
NCT07483684
A Randomized, Open-Label, Active-Controlled, Multicenter Phase III Clinical Study to Evaluate Injection TQB2102 Versus Investigator's Choice of Treatment Regimens in Patients With HER2 IHC3+ Advanced Colorectal Cancer Who Progressed After Treatment With Oxaliplatin, Irinotecan and Fluoropyrimidine-Based Drugs
NCT07043725
A Randomized, Open-label, Multicenter, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection Versus TCbHP in Neoadjuvant Treatment of Breast Cancer With Positive HER2 Expression
100 项与 TQB-2102 相关的临床结果
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100 项与 TQB-2102 相关的转化医学
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100 项与 TQB-2102 相关的专利（医药）
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12
项与 TQB-2102 相关的文献（医药）2026-05-01ANNALS OF ONCOLOGY
Preclinical characterization and phase I results of TQB2102, a first-in-class HER2 biparatopic antibody-drug conjugate, in patients with advanced solid tumors
Article
作者: Chen, T X ; Xia, W ; Tian, X ; Yu, Y ; Zhang, S ; Zhang, Z P ; Xiong, H H ; Lin, R B ; Lin, S Y ; Zheng, Q F ; Qu, X J ; Ruan, D Y ; Liu, Z Y ; Xu, R H ; Shen, C ; Lv, P ; Lou, L G ; Suo, A L ; Tang, S N ; Zhang, Y Q ; Wang, S S ; Wang, X ; Du, X B ; Bi, X W ; Li, Y H ; Huang, J J ; Li, X ; Yin, Y M ; Peng, J J ; Xu, F ; Shi, Y X ; Hong, R X ; Yuan, Z Y ; Jiang, K K ; Li, N ; Wang, L ; Xu, T J ; Xue, C ; An, X
BACKGROUND:
TQB2102 is a next-generation biparatopic antibody-drug conjugate targeting human epidermal growth factor receptor 2 (HER2) extracellular domain 2 (ECD2) and ECD4 epitopes that is conjugated to a topoisomerase I inhibitor via an enzyme-cleavable linker. This study evaluated the safety, efficacy, and pharmacokinetics of TQB2102 in patients with advanced solid tumors.
PATIENTS AND METHODS:
In this phase I, multicenter, first-in-human trial, patients with advanced solid tumors were recruited from 12 centers in China. Eligible patients received intravenous TQB2102 once every 3 weeks. This phase I trial included a dose-escalation phase (1.5, 3.0, 4.5, 6.0, 7.5, and 9.0 mg/kg) and a dose-expansion phase (6.0 and 7.5 mg/kg). The primary endpoints were to assess the safety and determine the dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended phase II dose (RP2D) of TQB2102.
RESULTS:
Between 8 March 2023 and 1 February 2025, 195 patients were enrolled, mainly those having metastatic breast cancer (MBC, n = 80), colorectal cancer (CRC, n = 37), and gastric/gastroesophageal junction (G/GEJ) adenocarcinoma (n = 37). No DLTs occurred, and the MTD was not reached. The RP2D was selected as 6.0 mg/kg and 7.5 mg/kg every 3 weeks. The most common grade ≥3 treatment-related adverse events were decreased neutrophil count (23.2%), decreased white blood cell count (10.8%), anemia (8.8%), and decreased lymphocyte count (8.2%). Only one patient (0.5%) had drug-related interstitial lung disease. The objective response rate (ORR) was attained in patients with HER2-positive solid tumors, including MBC at 52.4%, CRC at 38.7%, and G/GEJ adenocarcinoma at 40.0%. Notably, patients with HER2-low MBC achieved an ORR of 47.2%. The ORRs were 70.0% and 50.0% in HER2-positive and HER2-low MBC patients with brain metastases.
CONCLUSIONS:
TQB2102 demonstrates a manageable safety profile and preliminary antitumor activity in advanced solid tumors. A phase III trial in patients with HER2-low MBC has been initiated.
2026-01-01JOURNAL OF CLINICAL ONCOLOGY
Efficacy and Safety of Neoadjuvant TQB2102 in Locally Advanced or Early Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: A Randomized, Open-Label, Multicenter, Phase II Trial
Article
作者: Hu, Yan-Yan ; Liu, Guang-Yu ; Wang, Zhi-Hong ; Wu, Jiong ; Shao, Zhi-Ming ; Zhang, Qing-Yuan ; Hu, Xiao-Bo ; Zhang, Wen-Juan ; Li, Jun-Jie ; Li, Zhen-Ling ; Zeng, Xiao-Hua ; Chen, Li
PURPOSE:
To evaluate the efficacy and safety of the bispecific human epidermal growth factor receptor 2 (HER2)–directed antibody-drug conjugate (ADC) TQB2102 in the neoadjuvant treatment of HER2-positive breast cancer.
PATIENTS AND METHODS:
This randomized, open-label, multicenter, phase II study (ClinicalTrials.gov identifier:
NCT06198751
) enrolled HER2-positive patients with stage II and III disease. Patients were stratified by hormone receptor status and randomly assigned (1:1) to receive 6.0 mg/kg once every 3 weeks of TQB2102 for six (cohort 1) or eight cycles (cohort 2) or 7.5 mg/kg once every 3 weeks for six (cohort 3) or eight cycles (cohort 4). The primary end point was total pathologic complete response (tpCR) rate across all four cohorts (n = 26 per cohort). When the lower limit of the 90% CI (Clopper-Pearson exact binomial test) for tpCR rate exceeded 40%, efficacy was considered better than that of the historical control.
RESULTS:
Between February 5, 2024, and September 24, 2024, 104 patients were enrolled, with 26 patients in each cohort. The tpCR rates were 57.7% (15 of 26 [90% CI, 43.2 to 71.3];
P
= .04) for cohort 1, 76.9% (20 of 26 [90% CI, 62.3 to 87.6];
P
< .01) for cohort 2, 61.5% (16 of 26 [90% CI, 46.5 to 74.8];
P
= .02) for cohort 3, and 69.2% (18 of 26 [90% CI, 54.6 to 81.3];
P
< .01) for cohort 4. The incidence rates of grade ≥3 treatment-related adverse events were 23.1% (6 of 26) for cohort 1, 30.8% (8 of 26) for cohort 2, 30.8% (8 of 26) for cohort 3, and 26.9% (7 of 26) for cohort 4. No treatment-related deaths occurred in any groups.
CONCLUSION:
To our knowledge, this was the first study to report the efficacy and safety of the bispecific HER2-directed ADC TQB2102 in the neoadjuvant setting for HER2-positive breast cancer. TQB2102 showed robust activity and was well-tolerated.
2024-11-14JOURNAL OF MEDICINAL CHEMISTRY
Evaluation of Double Self-Immolative Linker-Based Antibody–Drug Conjugate FDA022-BB05 with Enhanced Therapeutic Potential
Article
作者: Yin, Sicheng ; Liu, Shuangxi ; Zhang, Yifan ; Yang, Tong ; Zhang, Wenbo ; Shen, Keyu ; Xie, Qian ; Zhu, Shulei ; Gao, Bei ; Wu, Yinghan ; Song, Ruiwen ; Cao, Xuemei ; Qiu, Xuefei ; Cheng, Zhiyang ; Wang, Baoxia ; Zhao, Teng ; Xu, Jun ; Wu, Jingsong ; Li, Weinan ; Wang, Lei ; Guo, Qingsong ; Lu, Wei
Typical antibody-drug conjugates (ADCs) with valine-alanine linkage, often conjugated with the amino group in payloads, face challenges when interacting with hydroxyl group-containing payloads. Herein, we introduced a transformative Val-Ala-based double self-immolative linker-payload platform, reshaping ADCs by optimizing hydroxyl group-containing payload integration. Utilizing this platform, FDA022-BB05 was successfully conjugated with the hydroxyl group-containing payload DXd using trastuzumab (FDA022) as the monoclonal antibody (mAb). FDA022-BB05 demonstrated enhanced stability, effective cathepsin B sensitivity, reduced cell proliferation, increased bystander killing, and targeted delivery. Notably, acute toxicity evaluations in diverse preclinical models indicated favorable safety profiles and tolerability, with a broad therapeutic index in HER2-positive and -negative xenografts. Overall, these compelling findings support the promising therapeutic potential of FDA022-BB05, emphasizing the significance of diverse linker-payload platform strategies. This ADC is a valuable addition to targeted cancer therapy development, currently advancing through phase I clinical trials.
1,091
项与 TQB-2102 相关的新闻（医药）2026-11-08
优先审批抗体药物偶联物引进/卖出临床3期疫苗
2026-11-08
·秋日启境
2026-11-08
·抗体圈
抗体药物偶联物引进/卖出临床1期多肽偶联药物上市批准
100 项与 TQB-2102 相关的药物交易
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研发状态
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| HER2低表达乳腺癌 | 申请上市 | 中国 | 2026-09-11 | |
| HER2阳性结直肠癌 | 临床3期 | 中国 | 2026-03-24 | |
| 晚期结直肠腺癌 | 临床3期 | 中国 | 2026-03-01 | |
| 晚期 HER2 阳性乳腺癌 | 临床3期 | 中国 | 2025-07-07 | |
| HER2阳性转移性乳腺癌 | 临床3期 | 中国 | 2025-06-23 | |
| HR阳性/HER2低表达乳腺癌 | 临床3期 | 中国 | 2024-09-24 | |
| 晚期恶性实体瘤 | 临床2期 | 中国 | 2026-05-27 | |
| HER2阳性实体瘤 | 临床2期 | 中国 | 2026-05-27 | |
| 女性生殖器官肿瘤 | 临床2期 | 中国 | 2025-03-13 | |
| HER2阳性胃食管腺癌 | 临床2期 | 中国 | 2024-11-21 |
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临床结果
临床结果
适应症
分期
评价
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临床2期 | 86 | TQB2102 7.5 mg/kg + bemotrizumab | 鹹廠製窪餘觸鬱糧窪糧(糧衊壓襯選衊獵餘鑰壓) = 鹹艱積鏇衊窪獵艱衊襯 顧糧鹽遞鬱願鏇獵膚範 (餘鹽衊窪鑰遞構艱願壓 ) 更多 | 积极 | 2026-10-23 | ||
TQB2102 7.5 mg/kg + bemotrizumab + capecitabine 1000 mg/m2 | 鹹廠製窪餘觸鬱糧窪糧(糧衊壓襯選衊獵餘鑰壓) = 簾糧鬱網壓觸選廠鏇餘 顧糧鹽遞鬱願鏇獵膚範 (餘鹽衊窪鑰遞構艱願壓 ) 更多 | ||||||
临床1期 | HER2阳性胆道肿瘤 HER2 Positive | 44 | TQB2102 7.5 mg/kg | 顧廠壓築夢願廠願艱醖(膚鏇簾淵衊蓋齋鑰選壓) = 壓構壓餘範鹽範鑰壓範 網顧蓋獵齋餘窪鹽襯憲 (醖蓋憲鹹顧範獵觸艱選 ) 更多 | 积极 | 2025-12-05 | |
TQB2102 6.0 mg/kg | 築齋膚鏇衊窪鹹簾顧鑰(齋遞構積顧選襯廠製蓋) = 鏇夢遞鑰鹹膚觸願壓製 鏇網鏇齋憲繭製繭獵淵 (蓋襯觸壓淵獵鹽衊夢構, 2.3 ~ 51.8) 更多 | ||||||
临床2期 | HER2阳性乳腺癌 HER2 Positive | 104 | TQB2102 6.0 mg/kg (6 cycles) | 夢醖鹽構繭廠淵網蓋壓(膚願壓憲鏇廠憲願齋夢) = 襯窪簾遞憲壓獵製構襯 艱繭淵簾積醖蓋窪夢範 (鏇選膚齋淵壓壓獵鑰蓋, 43.2 ~ 71.3) 更多 | 积极 | 2025-11-25 | |
TQB2102 6.0 mg/kg (8 cycles) | 夢醖鹽構繭廠淵網蓋壓(膚願壓憲鏇廠憲願齋夢) = 艱窪遞夢壓艱積夢顧鑰 艱繭淵簾積醖蓋窪夢範 (鏇選膚齋淵壓壓獵鑰蓋, 62.3 ~ 87.6) 更多 | ||||||
WCLC2025 人工标引  | 临床2期 | 59 | (HER2 mutation) | 簾窪範繭襯艱顧製繭餘(製繭衊淵糧糧顧襯觸築) = 遞膚願壓醖衊壓網糧製 窪範簾壓簾範網膚鹽範 (鏇獵衊夢網鑰糧襯膚糧 ) 更多 | 积极 | 2025-09-09 | |
(HER2 gene amplification or protein overexpression, IHC 2+/3+) | 簾窪範繭襯艱顧製繭餘(製繭衊淵糧糧顧襯觸築) = 鬱製糧構願艱選選衊衊 窪範簾壓簾範網膚鹽範 (鏇獵衊夢網鑰糧襯膚糧 ) 更多 | ||||||
临床2期 | HER2突变型非小细胞肺癌 HER2 mutation | HER2 gene amplification or protein overexpression | EGFR mutation | 59 | (HER2 mutation) | 鏇鬱積構壓鏇選選獵築(構選壓鹽網選鏇餘遞蓋) = 衊選製襯鹽鬱遞製醖廠 積廠選膚蓋壓餘窪製繭 (憲衊壓餘壓蓋齋廠範蓋 ) 更多 | 积极 | 2025-09-09 | |
(HER2 gene amplification or protein overexpression (IHC 2+/3+)) | 鏇鬱積構壓鏇選選獵築(構選壓鹽網選鏇餘遞蓋) = 淵壓襯鏇繭簾網鹽築鹹 積廠選膚蓋壓餘窪製繭 (憲衊壓餘壓蓋齋廠範蓋 ) 更多 | ||||||
临床1期 | HER2低表达乳腺癌 HER2 low-expressing | 73 | 網獵築衊齋夢廠鹽網鹽(鬱繭製觸遞獵築夢鏇膚) = 構窪餘蓋淵鑰淵糧遞鏇 觸膚憲憲顧鹽願顧獵醖 (網鑰觸齋觸衊築製膚餘 ) | 积极 | 2025-05-30 | ||
網獵築衊齋夢廠鹽網鹽(鬱繭製觸遞獵築夢鏇膚) = 鹹窪鑰糧願糧窪憲鬱鑰 觸膚憲憲顧鹽願顧獵醖 (網鑰觸齋觸衊築製膚餘 ) | |||||||
临床1期 | 181 | 壓夢構繭築願蓋鑰觸鑰(蓋憲鑰顧鏇繭網夢積襯) = 築鹽窪襯鏇範構積鹽夢 範鑰醖願壓繭鹹遞夢衊 (憲糧鹹窪糧鹹構鬱簾鑰 ) 更多 | 积极 | 2025-05-30 | |||
(HER2 positive MBC) | 壓夢構繭築願蓋鑰觸鑰(蓋憲鑰顧鏇繭網夢積襯) = 製糧餘鑰襯鬱築淵糧襯 範鑰醖願壓繭鹹遞夢衊 (憲糧鹹窪糧鹹構鬱簾鑰 ) 更多 | ||||||
临床2期 | 52 | (6 cycles) | 構鬱鏇積選襯製遞壓範(憲醖糧選選選範蓋範糧) = 鹹鑰淵鬱獵範遞觸窪簾 選鹽夢糧淵鑰顧選壓鹽 (鑰網鬱齋窪簾衊獵鹽齋, 36.9% ~ 76.7) 更多 | 积极 | 2025-05-30 | ||
(8 cycles) | 構鬱鏇積選襯製遞壓範(憲醖糧選選選範蓋範糧) = 鏇鏇齋艱夢淵衊網範鹹 選鹽夢糧淵鑰顧選壓鹽 (鑰網鬱齋窪簾衊獵鹽齋, 56.3% ~ 91) 更多 |
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