Drugs / Tifcemalimab
Trials 20
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT06732258 | Jan 2025 → Feb 2026 | small cell lung carcinoma | Sichuan University | Withdrawn | No outcome recorded |
| Phase 1 | NCT05427396 | Jul 2022 → Jan 2024 | colorectal cancer, esophageal squamous cell carcinoma | Shanghai Junshi Bioscience Co., Ltd. | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT04773951 | Apr 2021 → Apr 2023 | melanoma, renal carcinoma, urothelial carcinoma | Shanghai Junshi Bioscience Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04477772 | Jul 2020 → Mar 2024 | lymphoma | Shanghai Junshi Bioscience Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04278859 | Apr 2020 → Jul 2023 | neoplasm | Shanghai Junshi Bioscience Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04137900 | Oct 2019 → Mar 2026 | metastatic malignant neoplasm | TopAlliance Biosciences | Unknown | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT06370754 | Apr 2024 → Apr 2026 overdue | malignant pancreatic neoplasm | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT05664971 | Feb 2023 → Oct 2025 | lung cancer | Shanghai Junshi Bioscience Co., Ltd. | Completed | No outcome recorded |
| Phase 1/2 | NCT05000684 | Aug 2021 → Oct 2024 | lung cancer | Shanghai Junshi Bioscience Co., Ltd. | Completed | No outcome recorded |
| Phase 1/2 | NCT04929080 | May 2021 → Mar 2023 | head and neck squamous cell carcinoma, nasopharyngeal carcinoma | Shanghai Junshi Bioscience Co., Ltd. | Completed | No outcome recorded |
| Phase 28 trials | ||||||
| Phase 2 | NCT06730932 | Oct 2025 → Oct 2026 expected | — | RenJi Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07101614 | Sep 2025 → Nov 2027 expected | triple-negative breast carcinoma | Shengjing Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06924606 | Jul 2025 → Jul 2026 | non-small cell lung carcinoma | Shanghai Junshi Bioscience Co., Ltd. | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT06648200 | Nov 2024 → Sep 2030 expected | small cell lung carcinoma | Shanghai Pulmonary Hospital, Shanghai, China | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06588335 | Sep 2024 → Sep 2025 overdue | esophageal squamous cell carcinoma | Henan Provincial People's Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06690697 | Jun 2024 → Jun 2026 overdue | clear cell renal carcinoma | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT06256237 | Apr 2024 → Jan 2027 expected | small cell lung carcinoma | Shanghai Pulmonary Hospital, Shanghai, China | Recruiting | No outcome recorded |
| Phase 2 | NCT05891080 | Jul 2023 → Jul 2025 overdue | non-small cell lung carcinoma | Shanghai Pulmonary Hospital, Shanghai, China | Not yet recruiting | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT06170489 | Dec 2023 → May 2025 overdue | Hodgkins lymphoma | Shanghai Junshi Bioscience Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT06095583 | Nov 2023 → Jul 2027 expected | small cell lung carcinoma | Shanghai Junshi Bioscience Co., Ltd. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2024-04-01 | Shanghai Junshi Bioscience Co., Ltd. | Regulatory 日本PMDA同意君实生物开展tifcemalimab联合特瑞普利单抗治疗局限期小细胞肺癌患者的Ⅲ期临床研究 junshipharma.com ↗
北京时间2024年4月1日，君实生物（1877.HK，688180.SH）宣布，日本药品和医疗器械管理局（PMDA）已于近日同意公司开展抗BTLA单抗tifcemalimab（产品代号：TAB004/JS004）联合特瑞普利单抗作为局限期小细胞肺癌（LS-SCLC）放化疗后未进展患者的巩固治疗的随机、双盲、安慰剂对照、国际多中心Ⅲ期临床研究。 |
| 2023-06-28 | Shanghai Junshi Bioscience Co., Ltd. | Regulatory 美国FDA同意君实生物开展tifcemalimab（抗BTLA单抗）联合特瑞普利单抗治疗局限期小细胞肺癌患者的III期临床研究 junshipharma.com ↗
北京时间2023年6月28日，君实生物（1877.HK，688180.SH）宣布，美国食品药品监督管理局（FDA）已于近日同意公司开展抗BTLA单抗tifcemalimab（产品代号：TAB004/JS004）联合特瑞普利单抗作为局限期小细胞肺癌（LS-SCLC）放化疗后未进展患者的巩固治疗的随机、双盲、安慰剂对照、国际多中心III期临床研究。 |
| 2022-12-11 | Shanghai Junshi Bioscience Co., Ltd. | Results 君实生物在第64届美国血液学会（ASH）年会公布抗BTLA单抗tifcemalimab治疗复发或难治性淋巴瘤的研究结果 junshipharma.com ↗
本次更新结果发现，在28例接受tifcemalimab联合特瑞普利单抗治疗的可评估复发或难治性淋巴瘤患者中，尽管85%患者曾接受抗PD-1抗体治疗后进展，但仍获得39.3%的ORR和85.7%的DCR，且该组中所有获得缓解的患者中位DoR仍未成熟。 |
| 2022-06-07 | Shanghai Junshi Bioscience Co., Ltd. | Results 君实生物宣布icatolimab和特瑞普利单抗近40项研究成果在2022年美国临床肿瘤学会（ASCO）年会上公布 junshipharma.com ↗
结果显示，在单药治疗部分的25例可评估患者中，观察到1例部分缓解（PR）和7例疾病稳定（SD）。 |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-04-01 | Shanghai Junshi Bioscience Co., Ltd. | 日本PMDA同意君实生物开展tifcemalimab联合特瑞普利单抗治疗局限期小细胞肺癌患者的Ⅲ期临床研究 junshipharma.com ↗ |
| 2023-06-28 | Shanghai Junshi Bioscience Co., Ltd. | 美国FDA同意君实生物开展tifcemalimab（抗BTLA单抗）联合特瑞普利单抗治疗局限期小细胞肺癌患者的III期临床研究 junshipharma.com ↗ |
| 2022-12-11 | Shanghai Junshi Bioscience Co., Ltd. | 君实生物在第64届美国血液学会（ASH）年会公布抗BTLA单抗tifcemalimab治疗复发或难治性淋巴瘤的研究结果 junshipharma.com ↗ |
| 2022-06-07 | Shanghai Junshi Bioscience Co., Ltd. | 君实生物宣布icatolimab和特瑞普利单抗近40项研究成果在2022年美国临床肿瘤学会（ASCO）年会上公布 junshipharma.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 21 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tifcemalimab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06732258 ↗ |
| Known as | Icatolimab | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095352 ↗ |
| Known as | JS004 | “combined with toripalimab and Tifcemalimab (JS004) in the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC).” NCT06732258 ↗ |
| Known as | JS004/TAB004 | “A Randomized, Double-Blind, Placebo-Controlled, Multi-Regional Phase III Clinical Study of Toripalimab Alone or in Combination With Tifcemalimab (JS004/TAB004) as Consolidation...” NCT06095583 ↗ |
| Known as | TAB004 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04137900 ↗ |
| Action | Inhibit | “Blockade of BTLA pathway and PD-1 pathway by monoclonal antibodies” NCT04137900 ↗ |
| Modality | Monoclonal antibody | “a recombinant humanized IgG4κ monoclonal antibody specific to BTLA” NCT04137900 ↗ |
| Route | Intravenous | “TAB004 alone or TAB004 plus toripalimab will be administered as a 60-minute i.v. infusion” NCT04137900 ↗ |
| Target | BTLA | “target receptor BTLA” NCT04137900 ↗ |