drugset
Drugs / ERFONRILIMAB
last change Mar 2026 re-read 9 days ago

ERFONRILIMAB

also known as KN046

Monoclonal antibody targets CD274, CTLA4 via inhibition

Developed for
non-small cell lung carcinoma · cancer · carcinoma · colorectal cancer · esophageal squamous cell carcinoma · hepatocellular carcinoma · thymic carcinoma · breast cancer
+8 more · digestive system cancer · HER2 positive breast carcinoma · lymphoma · malignant pancreatic neoplasm · neoplastic disease or syndrome · non-small cell squamous lung carcinoma · pancreatic ductal adenocarcinoma · triple-negative breast carcinoma
Investigated by
Jiangsu Alphamab Biopharmaceuticals Co., Ltd · Peking University Cancer Hospital & Institute · Peking University · Alphamab (Australia) Co Pty Ltd. · First Affiliated Hospital of Suzhou Medical College · Fudan University
+9 more · InxMed (Shanghai) Co., Ltd. · Shanghai Chest Hospital · Shanghai Pulmonary Hospital, Shanghai, China · Shanghai Zhongshan Hospital · Sunshine Lake Pharma Co., Ltd. · Suzhou Kintor Pharmaceutical Inc · Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Weill Medical College of Cornell University · Zhejiang Raygene Pharmaceuticals Co., Ltd

Trials 28

today NCT05832892 · Ph 1/2 NCT05985109 · Ph 2 NCT06099821 · Ph 2 NCT06023758 · Ph 2 NCT06020352 · Ph 2/3 NCT05985707 · Ph 2 NCT06834399 · Ph 2 NCT05827796 · Ph 1/2 NCT05420220 · Ph 2 NCT05149326 · Ph 3 NCT04925947 · Ph 2 NCT04984668 · Ph 1/2 NCT05001724 · Ph 2/3 NCT04601610 · Ph 1/2 NCT04612712 · Ph 1/2 NCT04521179 · Ph 2 NCT04469725 · Ph 2 NCT04474119 · Ph 3 NCT04542837 · Ph 2 NCT04165993 · Ph 2 NCT04040699 · Ph 1 NCT04054531 · Ph 2 NCT03925870 · Ph 2 NCT03872791 · Ph 1/2 NCT03927495 · Ph 2 NCT03838848 · Ph 2 NCT03733951 · Ph 1 NCT03529526 · Ph 1
201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT04040699 Sep 2019 → Sep 2022 HER2 positive breast carcinoma Peking University Completed No outcome recorded
Phase 1 NCT03733951 Dec 2018 → Jan 2023 cancer, lymphoma Jiangsu Alphamab Biopharmaceuticals Co., Ltd Completed No outcome recorded
Phase 1 NCT03529526 May 2018 → Oct 2019 cancer Alphamab (Australia) Co Pty Ltd. Unknown No outcome recorded
Phase 1/26 trials · 1 met primary
Phase 1/2 NCT05832892 Nov 2023 → Nov 2024 neoplastic disease or syndrome Shanghai Zhongshan Hospital Unknown No outcome recorded
Phase 1/2 NCT05827796 Dec 2022 → Dec 2025 overdue malignant pancreatic neoplasm InxMed (Shanghai) Co., Ltd. Recruiting No outcome recorded
Phase 1/2 NCT04984668 Nov 2021 → Apr 2025 cancer Suzhou Kintor Pharmaceutical Inc Unknown No outcome recorded
Phase 1/2 NCT04601610 Jun 2021 → May 2022 hepatocellular carcinoma Jiangsu Alphamab Biopharmaceuticals Co., Ltd Terminated No outcome recorded Stop: Business
Phase 1/2 NCT04612712 Jan 2021 → Jun 2022 — Suzhou Zelgen Biopharmaceuticals Co.,Ltd Terminated No outcome recorded Stop: Business
Phase 1/2 NCT03872791 May 2019 → Aug 2022 triple-negative breast carcinoma Jiangsu Alphamab Biopharmaceuticals Co., Ltd Completed Met primary
Phase 215 trials
Phase 2 NCT05985109 Oct 2023 → Dec 2026 expected colorectal cancer Peking University Cancer Hospital & Institute Recruiting No outcome recorded
Phase 2 NCT06099821 Oct 2023 → Dec 2026 expected digestive system cancer Peking University Cancer Hospital & Institute Recruiting No outcome recorded
Phase 2 NCT06023758 Sep 2023 → Sep 2025 overdue carcinoma Peking University Recruiting No outcome recorded
Phase 2 NCT05985707 Aug 2023 → Dec 2026 expected carcinoma Peking University Cancer Hospital & Institute Not yet recruiting No outcome recorded
Phase 2 NCT06834399 Apr 2023 → Dec 2024 colorectal cancer Zhejiang Raygene Pharmaceuticals Co., Ltd Terminated No outcome recorded Stop: Business
Phase 2 NCT05420220 Jul 2022 → Dec 2024 non-small cell lung carcinoma Jiangsu Alphamab Biopharmaceuticals Co., Ltd Completed No outcome recorded
Phase 2 NCT04925947 Dec 2021 → May 2023 thymic carcinoma Weill Medical College of Cornell University Terminated No outcome recorded
Phase 2 NCT04521179 Dec 2020 → Jan 2022 — Jiangsu Alphamab Biopharmaceuticals Co., Ltd Completed No outcome recorded
Phase 2 NCT04469725 Dec 2020 → Jul 2023 thymic carcinoma Jiangsu Alphamab Biopharmaceuticals Co., Ltd Terminated No outcome recorded Stop: Business
Phase 2 NCT04542837 Sep 2020 → Feb 2022 hepatocellular carcinoma Peking University Cancer Hospital & Institute Completed No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT06020352 Aug 2023 → Jul 2025 non-small cell lung carcinoma Shanghai Pulmonary Hospital, Shanghai, China Unknown No outcome recorded
Phase 2/3 NCT05001724 Oct 2021 → Feb 2023 non-small cell lung carcinoma Jiangsu Alphamab Biopharmaceuticals Co., Ltd Terminated No outcome recorded
Phase 32 trials · 1 met primary
Phase 3 NCT05149326 Jan 2022 → Apr 2024 pancreatic ductal adenocarcinoma Jiangsu Alphamab Biopharmaceuticals Co., Ltd Unknown No outcome recorded
Phase 3 NCT04474119 Sep 2020 → Aug 2022 non-small cell squamous lung carcinoma Jiangsu Alphamab Biopharmaceuticals Co., Ltd Unknown Met primary
Comparator or background therapy1 trial
Phase 1/2 NCT05425602 Background Jul 2022 → Dec 2023 — Maxinovel Pty., Ltd. Unknown No outcome recorded

News releases announcing trial results or a regulatory action · 35

DateIssuerRelease
2024-12-13 Jiangsu Alphamab Biopharmaceuticals Co., Ltd Results 康宁杰瑞于2024年ESMO IO大会公布KN046联合阿昔替尼治疗晚期非小细胞肺癌的Ⅱ期临床研究数据 alphamabonc.com ↗
在队列A中，PD-L1 TPS≥1%（N=44）和≥50%（N=15）患者的ORR分别为56.8%（95% CI 41.0，71.7）和73.3%（95% CI 44.9，92.2）；确认的ORR分别为54.5%（95% CI 38.8，69.6）和66.7%（95% CI 38.4，88.2）。
2024-03-22 Jiangsu Alphamab Biopharmaceuticals Co., Ltd Results KN046联合化疗一线治疗转移性非小细胞肺癌研究结果在Cell子刊全文发表 alphamabonc.com ↗
结果表明，KN046联合含铂双药化疗一线治疗转移性非小细胞肺癌疗效可观且耐受性好。
2024-02-06 Jiangsu Alphamab Biopharmaceuticals Co., Ltd Results 康宁杰瑞KN046联合白蛋白结合型紫杉醇一线治疗晚期三阴乳腺癌研究结果在Nature子刊全文发表 alphamabonc.com ↗
结果表明，KN046联合白蛋白结合型紫杉醇一线治疗三阴乳腺癌显示出令人欣喜的无进展生存期（PFS）和总生存期（OS）获益，且耐受性良好，安全性可控。
2023-10-24 Jiangsu Alphamab Biopharmaceuticals Co., Ltd Results 康宁杰瑞于ESMO公布KN046多项肺癌和胸腺癌研究新数据 alphamabonc.com ↗
KN046治疗既往EGFR-TKI(s)治疗失败的EGFR敏感突变晚期非小细胞肺癌疗效显著，生存获益明显延长，mOS达到20.2个月。
2023-07-10 Jiangsu Alphamab Biopharmaceuticals Co., Ltd Results KN046晚期非小细胞肺癌研究结果在国际知名期刊EJC发表 alphamabonc.com ↗
在3 mg/kg和5 mg/kg组中，BICR评估的客观缓解率（ORR）分别为13.3%和14.7%。
2023-06-07 Jiangsu Alphamab Biopharmaceuticals Co., Ltd Results KN046一期临床研究结果在国际知名期刊JITC发表 alphamabonc.com ↗
研究结果表明KN046具有良好的安全性，对晚期实体瘤患者尤其是鼻咽癌(NPC)患者具有良好的耐受性和抗肿瘤疗效；生物标志物分析发现高CD8表达和高PD-L1表达的患者的中位总生存期更长。
2023-06-06 Jiangsu Alphamab Biopharmaceuticals Co., Ltd Results 康宁杰瑞在ASCO 2023年会上更新KN026联合KN046治疗HER2阳性实体瘤的临床研究数据 alphamabonc.com ↗
其中15例结直肠癌患者ORR为53.3%(95% CI: 26.6, 78.7)，中位DOR为11.7个月(95% CI:3.2, NE)，中位PFS为12.2个月(95% CI: 2.7, NE)，12个月生存率为80.0%(95% CI: 50.0,93.1)。
2022-12-12 Jiangsu Alphamab Biopharmaceuticals Co., Ltd Results KN046联合白蛋白紫杉醇用于三阴乳腺癌治疗的最终研究结果在SABCS 2022公布 alphamabonc.com ↗
研究结果表明，KN046耐受性良好；KN046联合白蛋白结合型紫杉醇对晚期三阴乳腺癌患者有效，无论患者的PD-L1是否阳性，都显示出无进展生存期（PFS）和总生存期（OS）获益。
2022-10-31 Jiangsu Alphamab Biopharmaceuticals Co., Ltd Regulatory KN026联合KN046治疗HER2阳性胃或胃食管结合部癌注册临床研究获批 alphamabonc.com ↗
2022年10月31日，中国苏州，康宁杰瑞生物制药（股票代码：9966.HK），HER2双抗KN026联合PD-L1/CTLA-4 双抗KN046的Ⅲ期注册临床试验申请，获得国家药品监督管理局批准，用于治疗HER2阳性局部进展不可切除或转移性胃/胃食管结合部癌。
2022-09-14 Jiangsu Alphamab Biopharmaceuticals Co., Ltd Results KN046两项治疗晚期非小细胞肺癌的更新研究数据公布 alphamabonc.com ↗
64例患者进行疗效评估，客观缓解率（ORR）为14.1%（95% CI：6.64，25.02），中位无进展生存期（mPFS）为3.68个月（95% CI：2.89，5.52），中位总生存期（mOS）为18.40个月（95% CI：12.88，21.91）。
2022-09-14 Jiangsu Alphamab Biopharmaceuticals Co., Ltd Results KN046联合化疗一线治疗晚期非小细胞肺癌更新数据在ESMO 2022上公布 alphamabonc.com ↗
KN046联合含铂双药化疗一线治疗晚期非小细胞肺癌Ⅱ期临床研究（研究编号：KN046-202）的两年生存随访数据，以壁报形式在2022年欧洲肿瘤内科学会（ESMO 2022）年会上公布。
2022-09-14 Jiangsu Alphamab Biopharmaceuticals Co., Ltd Results KN026联合KN046用于一线HER2阳性胃/胃食管结合部癌治疗的最新数据公布 alphamabonc.com ↗
客观缓解率（ORR）高达77.8%（95% CI: 57.7, 91.4），疾病控制率（DCR）为92.6%（95% CI: 75.7, 99.1）。

All press releases naming this drug 37 releases

DateIssuerRelease

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 30 sources stand behind the page.

FieldValueCited text
Known as ERFONRILIMAB ChEMBL registry synonym — accepted as the source's own label CHEMBL4650483 ↗
Known as KN046 “This study aimed to evaluate the efficacy and safety of KN046, a novel recombinant humanised antibody targeting PD-L1 and CTLA-4 in advanced non-small cell lung cancer (NSCLC)...” PMID 37393762 ↗ Jun 2023
28

“and the dose of KN046 was 5 mg/kg as a fixed dose administered every 3 weeks.” NCT05425602 ↗

“KN046 is a PD-L1 - CTLA-4 bispecific antibody.” NCT04521179 ↗

“30 mg/kg Q3W KN026 5 mg/kg Q3W KN046” NCT04165993 ↗

NCT03927495 ↗

NCT04925947 ↗

NCT05149326 ↗

NCT03733951 ↗

NCT04984668 ↗

NCT06834399 ↗

NCT06023758 ↗

Show 18 more sources
Action Inhibit “Programmed cell death 1 ligand 1 inhibitor” CHEMBL4650483 ↗
2

“Cytotoxic T-lymphocyte protein 4 inhibitor” CHEMBL4650483 ↗

“Anti-PD-L1 / CTLA-4 Bispecific Antibody” NCT05425602 ↗
Modality Monoclonal antibody “KN046 is a PD-L1 - CTLA-4 bispecific antibody.” NCT04521179 ↗
Route Intravenous “Intravenous (IV) infusions” NCT03733951 ↗
Target CD274 “Programmed cell death 1 ligand 1 inhibitor” CHEMBL4650483 ↗
Target CTLA4 “Cytotoxic T-lymphocyte protein 4 inhibitor” CHEMBL4650483 ↗