CN / EN
CN / EN

Technology & Product Pipeline

Current position： Home Technology & Product Pipeline Clinical Development Platform(Pipeline)

Clinical Development Platform(Pipeline)

Product pipeline
Patient relationships
Registration number Status of trial Name of drug Indication Popular trial subject (patient recruitment link)
CTR20232608 In progress; enrollment completed KL590586 capsules Advanced solid tumors harboring RET fusions or mutations To evaluate the randomized, open-label, two-cycle, double-cross food effects of KL590586 capsules in healthy subjects in a phase I clinical trial
CTR20231740 In progress A166 For Injection HER2-positive unresectable or metastatic breast cancer A randomized, open-label, controlled trial of A166 for injection versus trastuzumab emtansine for injection (T-DM1) in patients with HER2-positive unresectable or metastatic breast cancer who were previously treated with trastuzumab and taxanes , Multicenter phase III clinical trial
CTR20230825
NCT05816252		 In progress SKB264 for Injection NSCLC Phase 2 clinical study of SKB264 monotherapy or combination therapy for advanced or metastatic NSCLC patients
CTR20231535
NCT05870319		 In progress SKB264 for Injection Locally advanced or metastatic NSCLC with EGFR mutations that have failed treatment with EGFR-TKI A phase 3 study on the efficacy of SKB264 monotherapy compared to the combination of pemetrexed and platinum-based therapy in locally advanced or metastatic NSCLC with EGFR mutations that have failed treatment with EGFR-TKI
CTR20181301
NCT05311397		 In progress; recruitment completed A166 For Injection HER2 expression locally advanced or metastatic solid tumor Phase 1 clinical study on the safety and tolerability of A166 injectable solution
CTR20201069
NCT04152499		 In progress SKB264 for Injection Solid tumor SKB264 Phase 1-2 Trial in patients with locally advanced or metastatic solid tumors
CTR20202664 Completed KL130008 for Capsule Rheumatoid arthritis Research to evaluate efficacy and safety of KL130008 capsule for mild or moderate activity RA patients
CTR20210516 In progress; recruitment completed A166 For Injection Non-small cell lung cancer Observe efficacy and safety for overexpression of A166 for injection in non-small cell lung cancer her2 or patients with her2 mutations)
CTR20211028 In progress KL-A289 for Injection Advanced solid tumors Phase 1a/1b clinical trial of injectable KL-A289 in monotherapy or combination therapy for advanced solid tumors
CTR20211066 In progress SKB337 for Injection Advanced solid tumors Phase 1 clinical trial of open and dose expansion study for safety, tolerability and pharmacokinetic of injectable SKB337 in patients with advanced solid tumors
CTR20211319 In progress A166 For Injection Urothelial cancer Single-arm and open Phase 1b clinical trial of A166 for injection for patients with HER2 overexpression unresectable locally advanced, relapsed or metastatic urothelial cancer who have failed prior standard of care
CTR20211547
NCT05265091		 In progress KL590586 for Capsule Advanced solid tumors with RET gene fusions or mutations Assess safety, tolerability and pharmacokinetic of KL590586 capsule in advanced solid tumors patients with RET gene fusions or mutations
CTR20212950 In progress A166 For Injection HER2-positive Advanced malignant solid tumors Phase 1b clinical trial of A166 for injection for patients with HER2-positive Colorectal Cancer
CTR20213396 In progress A166 For Injection Gastric cancer or GEJ cancer Open and multi-center Phase 1b clinical trial of A166 for injection in patients with HER2-positive locally advanced or metastatic gastric cancer or GEJ cancer
CTR20220285
NCT05367635		 In progress SKB315 for Injection Advanced solid tumors with CLDN18.2 expression A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SKB315 for Injection in Patients with Advanced Solid Tumors Expressing CLDN18.2
CTR20220691
NCT05294172		 In progress KL-A167 for Injection Recurrent or metastatic nasopharyngeal carcinoma Phase 3 clinical research of injectable KL-A167 in patients withrecurrent or metastatic nasopharyngeal carcinoma
CTR20220878
NCT05347134		 In progress SKB264 for Injection Triple-negative breast cancer Phase 3 trial of SKB264 for patients with locally advanced, relapsed or metastatic triple-negative breast cancer who received at least 2L setting
CTR20220980
NCT05351788		 In progress SKB264 for Injection locally advanced or metastatic non-small cell lung cancer Phase 2 clinical research of SKB264 combination therapies in patients with advanced or metastatic non-small cell lung cancer
CTR20220985
NCT05387928		 In progress KL340399 for Injection Advanced solid tumors Phase 1 Clinical Study to Evaluate the Safety, Tolerability,Pharmacokinetics and Preliminary Efficacy of KL340399 Injection in Patients With Advanced Solid Tumors
CTR20221755
NCT05445908		 In progress SKB264 for Injection Triple-negative breast cancer Phase 2 clinical research of SKB264 in combination with KL-A167 as compared with SKB264 monotherapy for patients with triple-negative breast cancer
CTR20221772
NCT05549804		 In progress KL340399 for Injection Advanced solid tumors Phase 1 clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of KL340399 Intratumoral in Patients With Advanced Solid Tumors
CTR20221881
NCT05496426		 In progress KL130008 for Capsule severe alopecia areata Clinical research to evaluate safety and effectiveness of KL130008 capsule
CTR20221961
NCT05790694		 In progress HBM9378（SKB378）for Injection Asthma Phase 1 clinical research in Chinese healthy subjects of randomized, double-blind, placebo-controlled, single-dose and dose expansion to evaluate safety and pharmacokinetic of HBM9378(SKB378) following subcutaneous injection for dosing
CTR20222274 In progress KL280006 for Injection Uremic pruritus Research to evaluate effectiveness and safety of Injectable KL280006 in patients on hemodialysis with moderate-to-severe uremic pruritus
CTR20222948
NCT05631262		 In progress SKB264 for Injection Advanced solid tumors Multi-center and open Phase 2 research to evaluate effectiveness and safety of SKB264 monotherapy in selected patient with advanced solid tumors
CTR20223165
NCT05642780		 In progress SKB264 for Injection Solid Tumors A basket study to evaluate effectiveness and safety of SKB264 in combination with Pembrolizumab in subjects for solid tumors
CTR20230853 Completed KL130008 capsule (new prescription drug) Healthy subjects Randomized, open, two-period, two-sequence, and double-crossover Phase 1 clinical research to evaluate bioequivalence and food effects of KL130008 capsule in healthy subjects
CTR20202451
NCT04835142		 In progress; recruitment completed Recombinant Chimeric Anti-EGFR Monoclonala Antibody For Injection RAS wild-type metastatic colorectal cancer Phase 3 clinical research to compare effectiveness and safety of each of A140 and Erbitux® in combination with mFOLFOX6 as a first-line treatment option in patients with RAS wild-type metastatic colorectal cancer
CTR20192416 In progress; enrollment completed KL-A167 for Injection lymphomas Research on continuous administration of injectable KL-A167 for lymphomas
CTR20212088 In progress; enrollment completed A166 For Injection Breast cancer Phase 2 clinical research of A166 for injection in end-stage HER2+ BC patients
CTR20180954
NCT03580564		 Completed KL-A167 for Injection relapsed or refractory Hodgkin lymphoma Phase 2 clinical research of Injectable KL-A167 for relapsed or refractory Hodgkin lymphoma
CTR20181197 Completed KL-A167 for Injection Relapsed or refractory malignant lymphomas Phase 1 clinical research of Injectable KL-A167 for relapsed or refractory malignant lymphomas
CTR20181198 Completed KL-A167 for Injection Advanced solid tumors Phase 1a research of injectable KL-A167 for advanced solid tumors
CTR20181491 Completed KL-A167 for Injection Relapsed or refractory Extranodal NK/T-cell lymphoma(nasal type) with EB virus+ and B-cell non-Hodgkin lymphoma Phase 1b research of Injectable KL-A167 for relapsed or refractory lymphoma
CTR20181763 Completed KL130008 for capsule Rheumatoid Arthritis Phase 1 research of safety and tolerability of KL130008 capsule in healthy subjects
CTR20182165 Completed KL280006 for Injection post-surgery analgesic Research of safety and pharmacokinetic of injectable KL280006 in healthy subjects
CTR20190152
NCT03848286		 Completed KL-A167 for Injection Relapsed or refractory nasopharyngeal cancer Phase 2 clinical research of Injectable KL-A167 in patients with relapsed or metastatic nasopharyngeal cancer
CTR20191446 Completed KL130008 for capsule Rheumatoid Arthritis Phase 1 clinical research of tolerability and PK/PD of KL130008 capsule in patients with Rheumatoid Arthritis
CTR20200985 Completed KL060332 for capsule Hepatitis B Phase 1a clinical research of safety, tolerability and pharmacokinetic of KL060332 capsule and KL060332 tablets in healthy subjects
CTR20201371 Completed KL280006 for Injection Acute pain Phase 2 clinical research of injectable KL280006 in post-surgery analgesic for laparoscopic operation
CTR20211299 Completed KL130008 for Capsule Rheumatoid Arthritis Research to evaluate efficacy and safety of KL130008 capsule in mild or moderate activity RA patients
CTR20211808 Completed SKB336 for Injection Prevention and treatment of thromboembolic disorders Phase 1a clinical research of safety, tolerability and pharmacokinetic of injectable SKB336 in healthy patients
CTR20212178 Completed KL060332片 Chronic Hepatitis B Research of safety, effectiveness and pharmacokinetic of KL060332 tablets in patients with chronic Hepatitis B
CTR20212404 Completed KL280006 for Injection Acute pain Phase 2 clinical trial for KL280006 injection for post-surgery analgesic to acute pain following laparoscopic operation had been completed
CTR20232807
NCT06081959		 In progress SKB264 for Injection HR+/HER2-breast cancer A Randomized, Open-label, Multicenter Phase 3 Study of SKB264 Versus Treatment of Physician's Choice (TPC) in Patients With Unresectable Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer Who Had Failed at Least One Line of Chemotherapy
CTR20232730 In progress; enrollment completed KL590586 capsules Advanced solid tumors harboring RET fusions or mutations Study on material balance and biotransformation of KL590586 capsules
请选择要上传的文件
取消 确定
关闭

1.作用机制：

SKB264是由科伦博泰拥有自主知识产权的靶向TROP2的人员化单克隆抗体、可酶促裂解的LINKER连接着新型拓扑异构酶I抑制剂组合而成的抗体偶联药物（TROP2-ADC），毒素分子具有中等细胞毒性，连接子可以很好地平衡细胞外的稳定性和细胞内的裂解。

2.临床试验：

SKB264目前正在中美开展针对多个肿瘤的II期临床试验，已初步获得令人期待的临床数据，同时也在积极推进联合用药的临床研究，以期早日为更多肿瘤患者带来福音。2022年上半年，SKB264已开展3项联合用药临床研究：

2022年4月11日，SKB264联合或不联合KL-A167（PD-L1单抗）一线治疗不可手术切除的局部晚期、复发或转移性TNBC患者的II期临床实验获批开展。CTR20221755

2022年4月7日，SKB264单药治疗至少经二线治疗失败的晚期或转移性TNBC患者的III期注册临床研究获批开展，成为首个进入注册性临床研究并具有自主知识产权的国产TROP2-ADC。CTR20220878

Patient recruitment

Registration number Status of trial Name of drug Indication Popular trial subject (patient recruitment link)
New Drug Research Platform Clinical Development Platform Production & Quality Platform Commercialization