Drugs / Tinengotinib
Trials 13
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT04705922 | Dec 2020 → Mar 2021 | — | TransThera Sciences (Nanjing), Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03654547 | Jan 2019 → Jan 2023 | triple-negative breast carcinoma | TransThera Sciences (Nanjing), Inc. | Completed | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT06457919 | Jun 2024 → Jun 2027 expected | prostate cancer | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06221774 | Feb 2024 → Aug 2025 | castration-resistant prostate carcinoma, clear cell renal carcinoma, urothelial carcinoma | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Unknown | No outcome recorded |
| Phase 1/2 | NCT05253053 | Apr 2022 → Aug 2024 | cholangiocarcinoma, gallbladder cancer, gastric cancer, prostate cancer +4 | TransThera Sciences (Nanjing), Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT04742959 | Mar 2021 → Feb 2024 | cholangiocarcinoma, gallbladder cancer, gastric cancer, prostate cancer +5 | TransThera Sciences (Nanjing), Inc. | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT07498478 | Mar 2026 → Jun 2027 expected | breast cancer | TransThera Sciences (Nanjing), Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT07052253 | Jul 2025 → May 2027 expected | hepatocellular carcinoma | Akeso | Recruiting | No outcome recorded |
| Phase 2 | NCT06057571 | Nov 2023 → Jul 2025 overdue | cholangiocarcinoma | TransThera Sciences (Nanjing), Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04919642 | Dec 2021 → Feb 2024 | cholangiocarcinoma | TransThera Sciences (Nanjing), Inc. | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT07328919 | Jan 2026 → Dec 2029 expected | intrahepatic cholangiocarcinoma | TransThera Sciences (Nanjing), Inc. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05948475 | Dec 2023 → Dec 2026 expected | cholangiocarcinoma | TransThera Sciences (Nanjing), Inc. | Active not recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT06370013 | — | cholangiocarcinoma | TransThera Sciences (Nanjing), Inc. | Available | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2026-05-27 | TransThera Sciences (Nanjing), Inc. | Regulatory 替恩戈替尼联合新型内分泌治疗用于经治后进展的转移性去势抵抗性前列腺癌中国II期临床试验获批开展 transthera.com ↗
公司核心产品替恩戈替尼(Tinengotinib, TT-00420) 联合新型内分泌治疗（NHT）用于经治后进展的转移性去势抵抗性前列腺癌(mCRPC)的II期临床试验，已于2026年5月25日获国家药品监督管理局（NMPA）批准。 |
| 2025-06-27 | TransThera Sciences (Nanjing), Inc. | Results 药捷安康宣布在《肿瘤学年鉴》发表了核心产品替恩戈替尼针对胆管癌的转化医学结果 transthera.com ↗
此外，研究还验证了其在体外和体内针对临床获得性 FGFR2 耐药突变的活性，并通过病例报告证明了其临床疗效。 |
| 2025-06-24 | TransThera Sciences (Nanjing), Inc. | Regulatory 药捷安康宣布FDA授予替恩戈替尼治疗mCRPC的快速通道认证 transthera.com ↗
药捷安康（南京）科技股份有限公司（“药捷安康”，“公司”）宣布，核心产品替恩戈替尼针对治疗去势抵抗性转移性前列腺癌（mCRPC），获得美国FDA的快速通道认证（FTD）。 |
| 2025-03-28 | TransThera Sciences (Nanjing), Inc. | Regulatory 药捷安康与康方生物达成战略合作：共同推进Tinengotinib联合卡度尼利/依沃西治疗晚期肝癌联合疗法 transthera.com ↗
本次合作的临床方案已于近日获得了中国国家药品监督管理局的临床默示许可。 |
| 2024-12-09 | TransThera Sciences (Nanjing), Inc. | Results 【2024 ESMO Asia】药捷安康公布tinengotinib联合阿替利珠单抗治疗晚期胆道系统肿瘤Ib/II期最新临床数据 transthera.com ↗
20例疗效可评估的肝内胆管癌（iCCA）患者中，客观缓解率（ORR）和疾病控制率（DCR）分别为25.0%和80.0%，中位无进展生存期（mPFS）为8.77个月，12个月生存率为70.1%。 |
| 2024-04-12 | TransThera Sciences (Nanjing), Inc. | Results 【2024 AACR Late Breaking】药捷安康公布tinengotinib针对FGFR1-3变异的泛实体瘤临床数据 transthera.com ↗
疗效为BOR 33.3%，DCR 88.2%，mPFS 6.90个月。 |
| 2024-01-23 | TransThera Sciences (Nanjing), Inc. | Results 【2024 ASCO GI】药捷安康tinengotinib获选口头报告/多项壁报，公开相关临床研究数据 transthera.com ↗
在大会上，公司通过口头报告形式展示了核心产品Tinengotinib针对既往经FGFR抑制剂治疗后获得性耐药的胆管癌患者的令人兴奋的II期临床中期研究数据（ORR 40%，DCR 90%），再次验证tinengotinib治疗有着明确未满足需求胆管癌患者的潜力。 |
| 2023-12-07 | TransThera Sciences (Nanjing), Inc. | Results 【2023 SABCS】药捷安康口头报告公开tinengotinib针对乳腺癌的临床数据 transthera.com ↗
11例HR+/HER2- 乳腺癌患者的肿瘤总体响应率（ORR）为45%，临床获益率（CBR，CR+PR+SD ≥ 24周）为64%，疾病控制率（DCR）为82%，中位无进展生存期（mPFS）为5.68个月。 |
| 2023-07-21 | TransThera Sciences (Nanjing), Inc. | Regulatory 双喜临门｜药捷安康tinengotinib（TT-00420）获CDE批准进入关键注册性临床，并被纳入突破性治疗品种名单 transthera.com ↗
南京，中国 | 2023年7月21日，药捷安康（南京）科技股份有限公司（以下简称“药捷安康”或“公司”）宣布，公司自主研发产品tinengotinib（TT-00420）于近日获中国国家药品监督管理局（NMPA）药品审评中心（CDE）批准开展关键注册性临床试验（FIRST-CN08），并纳入突破性治疗品种名单（以下简称“BTD”），用于治疗既往系统性化疗以及FGFR抑制剂治疗失败或复发的，不可切除的晚期或转移性胆管癌患者。 |
| 2023-04-19 | TransThera Sciences (Nanjing), Inc. | Results “AACR 2023” 药捷安康首次公开tinengotinib对携带FGFR变异的泛实体瘤的作用机制和治疗潜力 transthera.com ↗
报告展示了tinengotinib与FGFR的独特结合方式及体内外对FGFR 1/2/3卓越的抑制活性，为pan-FGFR实体瘤适应症的开发提供了理论和临床依据。 |
All press releases naming this drug 12 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 16 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | tinengotinib | “Patints orally self-administered tinengotinib 10 mg daily in 28-day cycles in 28-day treatment cycles until documented disease progression, unacceptable toxicity, or withdrawal...” PMID 41349554 ↗ Dec 202510“Tinengotinib (TT-00420), a Novel Spectrum-Selective Small-Molecule Kinase Inhibitor, Is Highly Active Against Triple-Negative Breast Cancer.” PMID 36223547 ↗ Feb 2023 “Study of TT-00420 (Tinengotinib) Tablet as Monotherapy and Combination Therapy in Patients With Advanced Solid Tumors” NCT04742959 ↗ “TT-00420 (Tinengotinib) Capsule” NCT04705922 ↗ “Drug: TT-00420 (tinengotinib)” NCT07052253 ↗ “TT-00420 (tinengotinib)” NCT07328919 ↗ |
| Known as | TT00420 | “This is a Phase II, open-label study to evaluate the efficacy and safety of TT00420 in patients with advanced/metastatic and surgically unresectable cholangiocarcinoma (CCA)...” NCT04919642 ↗10“Tinengotinib (TT-00420), a Novel Spectrum-Selective Small-Molecule Kinase Inhibitor, Is Highly Active Against Triple-Negative Breast Cancer.” PMID 36223547 ↗ Feb 2023 “TT-00420 (Tinengotinib) Tablets Combined With Fulvestrant Injection” NCT07498478 ↗ “TT-00420 (tinengotinib)” NCT06057571 ↗ |
| Action | Inhibit | “strongly inhibited Aurora A/B, FGFR1/2/3, VEGFRs, JAK1/2, and CSF1R in biochemical assays” PMID 36223547 ↗ Feb 2023 |
| Modality | Small molecule | “Novel Spectrum-Selective Small-Molecule Kinase Inhibitor” PMID 36223547 ↗ Feb 2023 |
| Route | Oral | “Administered Orally” NCT03654547 ↗ |
| Target | CSF1R | “strongly inhibited Aurora A/B, FGFR1/2/3, VEGFRs, JAK1/2, and CSF1R in biochemical assays” PMID 36223547 ↗ Feb 2023 |
| Target | FGFR1 | “strongly inhibited Aurora A/B, FGFR1/2/3, VEGFRs, JAK1/2, and CSF1R in biochemical assays” PMID 36223547 ↗ Feb 2023 |
| Target | JAK1 | “strongly inhibited Aurora A/B, FGFR1/2/3, VEGFRs, JAK1/2, and CSF1R in biochemical assays” PMID 36223547 ↗ Feb 2023 |