Drugs / KL-A167

Trials 6

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 25 trials
Phase 2 NCT07371208 Dec 2025 → Aug 2028 expected breast cancer Shanghai Jiao Tong University School of Medicine Recruiting No outcome recorded
Phase 2 NCT05445908 Aug 2022 → Sep 2027 expected breast carcinoma Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Active not recruiting No outcome recorded
Phase 2 NCT05351788 May 2022 → Aug 2026 overdue non-small cell lung carcinoma Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Recruiting No outcome recorded
Phase 2 NCT03848286 Mar 2019 → Jul 2021 metastatic malignant neoplasm, nasopharyngeal carcinoma Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Completed No outcome recorded
Phase 2 NCT03580564 Aug 2018 → Aug 2020 classic Hodgkin lymphoma Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Completed No outcome recorded
Phase 31 trial
Phase 3 NCT05294172 Jun 2022 → Dec 2027 expected metastatic carcinoma, nasopharyngeal carcinoma Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Active not recruiting No outcome recorded
Comparator or background therapy1 trial
Phase 2 NCT07296809 Background Jan 2026 → Dec 2028 expected small cell lung carcinoma Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 9

DateIssuerRelease
2025-08-19 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Results Nature Medicine Publishes Results of Phase II Study of Sacituzumab Tirumotecan Plus Tagitanlimab as First-Line Therapy for NSCLC kelun-biotech.com ↗
2025-01-21 Klus Pharma Inc. Regulatory Kelun-Biotech’s Product Tagitanlimab Approved for Marketing for Second Indication in China kluspharma.com ↗
2025-01-21 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Regulatory Kelun-Biotech’s Product Tagitanlimab Approved for Marketing in Second Indication in Combination with Cisplatin and Gemcitabine For the First-line Treatment of Patients with recurrent or metastatic NPC kelun-biotech.com ↗
2025-01-03 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Regulatory Kelun-Biotech's Anti-PD-L1 (Tagitanlima)Receives NMPA Approval for Marketing kelun-biotech.com ↗
This is the world's first PD-L1 monoclonal antibody approved for the treatment of NPC.
2024-12-31 Klus Pharma Inc. Regulatory Kelun-Biotech's Anti-PD-L1 (Tagitanlimab) Receives NMPA Approval for Marketing kluspharma.com ↗
This marks the world's first PD-L1 monoclonal antibody approved for the treatment of NPC.
2024-09-29 Klus Pharma Inc. Results Multiple Study Results of Kelun-Biotech’s TROP2-ADC SKB264 (sac-TMT) Presented at 2024 CSCO Congress kluspharma.com ↗
After median follow up of 14.0 mo and 6.9 mo for cohort 1A and 1B, the ORR was 48.6% (18/37, 2 pending confirmation), DCR was 94.6% and median PFS was 15.4 mo (95% CI: 6.7, NE)
2024-09-29 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Results Multiple Study Results of Kelun-Biotech’s TROP2-ADC SKB264 (sac-TMT) At 2024 CSCO Congress kelun-biotech.com ↗
After median follow up of 14.0 mo and 6.9 mo for cohort 1A and 1B, the ORR was 48.6% (18/37, 2 pending confirmation), DCR was 94.6% and median PFS was 15.4 mo
2024-05-24 Klus Pharma Inc. Results Two Abstracts of SKB264/sac-TMT (TROP2 ADC) published at 2024 ASCO Annual Meeting kluspharma.com ↗
At the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting to be held in Chicago, Illinois from May 31 to June 4, 2024, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the “Company”) will present the latest results from two clinical studies.
2024-05-24 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Results ASCO 2024| Two Abstracts of the Study Results of Kelun-Biotech’s TROP2-ADC SKB264/sac-TMT Published Today–OptiTROP-Breast01 study AND the OptiTROP-Lung01 study kelun-biotech.com ↗
The abstracts for the above studies were published on ASCO’s official website on [May 23, 2024], local time.

All press releases naming this drug 9 releases

DateIssuerRelease

Evidence & citations 2 cited values

Every value below carries the sentence it was read from. 7 sources stand behind the page.

FieldValueCited text
Known as KL-A167 “combined with KL-A167 (900 mg, Day 1, every 2 weeks)” NCT07371208 ↗
6

NCT05294172 ↗

NCT03848286 ↗

NCT05445908 ↗

NCT03580564 ↗

NCT05351788 ↗

NCT07296809 ↗

Route Intravenous “900 mg intravenously (IV)” NCT03580564 ↗