Drugs / Envafolimab
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Envafolimab

also known as KN035 · ASC22 · Envolimab · KN053

Monoclonal antibody targets CD274 via inhibition

Developed for
non-small cell lung carcinoma · biliary tract cancer · cancer · colorectal cancer · hepatocellular carcinoma · nasopharyngeal carcinoma · rectal cancer · biliary tract neoplasm
+31 more · chronic hepatitis B virus infection · colon carcinoma · esophageal squamous cell carcinoma · gastroesophageal junction adenocarcinoma · gastrointestinal stromal tumor · HIV infectious disease · lung neoplasm · renal cell carcinoma · soft tissue sarcoma · cervical cancer · clear cell renal carcinoma · colonic neoplasm · colorectal neoplasm · digestive system neoplasm · endometrial cancer · gallbladder cancer · gastric adenocarcinoma · gastric cancer · HER2 positive breast carcinoma · malignant epithelial tumor of ovary · mucosal melanoma · myxofibrosarcoma · neoplasm · neoplastic meningitis · non-small cell squamous lung carcinoma · osteosarcoma · pancreatic neoplasm · prostate cancer · rectum adenocarcinoma · sarcoma · undifferentiated pleomorphic sarcoma
Investigated by
3D Medicines (Sichuan) Co., Ltd. · Fudan University · Sir Run Run Shaw Hospital · Sun Yat-sen University · Tianjin Medical University Cancer Institute and Hospital · Ascletis Pharmaceuticals Co., Ltd.
+62 more · Chongqing University Cancer Hospital · First Affiliated Hospital Xi'an Jiaotong University · Jiangsu Alphamab Biopharmaceuticals Co., Ltd · Peking Union Medical College Hospital · Second Affiliated Hospital, School of Medicine, Zhejiang University · The First Affiliated Hospital with Nanjing Medical University · Tracon Pharmaceuticals Inc. · Anhui Chest Hospital · Anhui Provincial Cancer Hospital · Anhui Provincial Hospital · Beijing Bethune Charitable Foundation · Beijing Clinical Service Center · Beijing Hospital · Bethune Charitable Foundation · Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Chipscreen Biosciences, Ltd. · Eastern Hepatobiliary Surgery Hospital · First Affiliated Hospital of Chongqing Medical University · First Affiliated Hospital of Fujian Medical University · Fujian Cancer Hospital · Fujian Medical University Union Hospital · Guangdong Provincial People's Hospital · Guizhou Provincial People's Hospital · Hairong Liu · Hebei Medical University · Henan Cancer Hospital · Huadong Hospital · Jian Li · Jiangsu Cancer Institute & Hospital · Jiangsu Simcere Pharmaceutical Co., Ltd. · Kangabio AUSTRALIA LTD PTY · Liangjun Zhu M.M. · Nanjing First Hospital, Nanjing Medical University · Northern Jiangsu People's Hospital · Peking University · Peking University First Hospital · Peking University Shenzhen Hospital · Qilu Hospital of Shandong University · RenJi Hospital · Second Affiliated Hospital of Guangzhou Medical University · Second Xiangya Hospital of Central South University · Shanghai 6th People's Hospital · Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Shanghai Public Health Clinical Center · Shanghai Zhongshan Hospital · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Tao Jiang · The Affiliated Hospital of Xuzhou Medical University · The First Affiliated Hospital of Xiamen University · The First People's Hospital of Lianyungang · The Second Affiliated Hospital of Chongqing Medical University · Three Gorges Hospital of Chongqing University · Tianjin Medical University Second Hospital · Tongji Hospital · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · West China Hospital · Yunnan Cancer Hospital · Zhangjiagang First People's Hospital · Zhejiang Cancer Hospital · Zhejiang University · Zhongda Hospital · 池畔

Trials 86 · started per year

today
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201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 14 trials
Phase 1 NCT07260305 Nov 2024 → Jan 2027 expected Kangabio AUSTRALIA LTD PTY Recruiting No outcome recorded
Phase 1 NCT03248843 Sep 2017 → Mar 2020 3D Medicines (Sichuan) Co., Ltd. Completed No outcome recorded
Phase 1 NCT03101488 Mar 2017 → Sep 2019 cancer 3D Medicines (Sichuan) Co., Ltd. Completed No outcome recorded
Phase 1 NCT02827968 Jan 2017 → Aug 2020 cancer 3D Medicines (Sichuan) Co., Ltd. Completed No outcome recorded
Phase 1/25 trials
Phase 1/2 NCT07636798 Jun 2026 → Mar 2029 expected biliary tract cancer West China Hospital Recruiting No outcome recorded
Phase 1/2 NCT06663007 Sep 2024 → May 2027 expected prostate cancer Tianjin Medical University Second Hospital Recruiting No outcome recorded
Phase 1/2 NCT06226766 Jan 2024 → Jul 2025 neoplasm Jiangsu Alphamab Biopharmaceuticals Co., Ltd Terminated No outcome recorded
Phase 1/2 NCT05448820 Nov 2022 → Nov 2023 soft tissue sarcoma Tracon Pharmaceuticals Inc. Unknown No outcome recorded
Phase 1/2 NCT05024214 Nov 2021 → Dec 2026 expected hepatocellular carcinoma, non-small cell lung carcinoma, renal cell carcinoma 3D Medicines (Sichuan) Co., Ltd. Recruiting No outcome recorded
Phase 272 trials
Phase 2 NCT04910386 Jun 2027 → Jun 2029 expected biliary tract neoplasm 3D Medicines (Sichuan) Co., Ltd. Not yet recruiting No outcome recorded
Phase 2 NCT07599995 May 2026 → Mar 2028 expected biliary tract cancer Sir Run Run Shaw Hospital Not yet recruiting No outcome recorded
Phase 2 NCT06059261 Feb 2026 → Feb 2027 expected nasopharyngeal carcinoma Chongqing University Cancer Hospital Recruiting No outcome recorded
Phase 2 NCT07283198 Dec 2025 → Aug 2027 expected non-small cell lung carcinoma Jiangsu Alphamab Biopharmaceuticals Co., Ltd Not yet recruiting No outcome recorded
Phase 2 NCT07256223 Dec 2025 → Nov 2027 expected clear cell renal carcinoma Fudan University Not yet recruiting No outcome recorded
Phase 2 NCT07159191 Sep 2025 → Feb 2027 expected renal cell carcinoma Peking Union Medical College Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07142863 Aug 2025 → Aug 2026 overdue osteosarcoma Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Not yet recruiting No outcome recorded
Phase 2 NCT06772233 Jul 2025 → Jul 2027 expected gastrointestinal stromal tumor Peking University Not yet recruiting No outcome recorded
Phase 2 NCT07559864 Jul 2025 → Jun 2027 expected gastrointestinal stromal tumor Jian Li Recruiting No outcome recorded
Phase 2 NCT07003815 Jun 2025 → Dec 2026 expected biliary tract cancer Tongji Hospital Not yet recruiting No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT06959693 Jun 2025 → Sep 2028 expected colorectal cancer Sun Yat-sen University Not yet recruiting No outcome recorded
Phase 33 trials
Phase 3 NCT06123754 Nov 2023 → Dec 2027 expected non-small cell lung carcinoma 3D Medicines (Sichuan) Co., Ltd. Recruiting No outcome recorded
Phase 3 NCT05752136 Apr 2023 → Apr 2025 overdue rectal cancer Sir Run Run Shaw Hospital Recruiting No outcome recorded
Phase 3 NCT03478488 Apr 2018 → Sep 2024 overdue biliary tract neoplasm 3D Medicines (Sichuan) Co., Ltd. Active not recruiting No outcome recorded
Phase 41 trial
Phase 4 NCT07573943 May 2024 → Dec 2026 expected chronic hepatitis B virus infection The Second Affiliated Hospital of Chongqing Medical University Recruiting No outcome recorded
Also used as a comparator or background therapy in 5 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT06074497 Comparator Dec 2023 → May 2026 overdue Kangabio AUSTRALIA LTD PTY Active not recruiting No outcome recorded
Phase 1 NCT05849311 Comparator May → Nov 2023 3D Medicines (Sichuan) Co., Ltd. Completed No outcome recorded
Phase 22 trials
Phase 2 NCT07327411 Background Dec 2025 → Feb 2027 expected refractory malignant neoplasm Second Affiliated Hospital of Soochow University Not yet recruiting No outcome recorded
Phase 2 NCT06698965 Background Oct 2024 → Oct 2029 expected small cell lung carcinoma Shanghai Chest Hospital Recruiting No outcome recorded
Phase not applicable1 trial
NCT06702566 Background Jul 2024 → Jul 2026 overdue acute leukemia, cancer Tianjin Medical University Cancer Institute and Hospital Recruiting No outcome recorded

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 92 sources stand behind the page.

FieldValueCited text
Known as envafolimab “Based on phase I clinical trial data of Envafolimab, a dose reduction design was conducted to minimize the incidence of adverse events while ensuring therapeutic efficacy.” NCT05914389
81

“Phase I study of envafolimab (KN035), a novel subcutaneous single-domain anti-PD-L1 monoclonal antibody, in Japanese patients with advanced solid tumors.” PMID 35932387 Aug 2022

“The subjects receive Envafolimab/placebo treatment with a dosage of 600 mg/3 ml subcutaneously injected every 3 weeks.” NCT06123754

“JSKN033 is a fixed-dose combination consisting of JSKN003 (a HER2-targeted ADC) and envafolimab (a PD-L1 inhibitor)” NCT07283198

“JSKN033 is a combination drug product comprised of JSKN003 and envafolimab for subcutaneous injection.” NCT06226766

“intraoperative arterial envafolimab and lenvatinib as first-line therapy for unresectable BTC” NCT07636798

Envafolimab, a humanized single-domain anti-PD-L1 antibody fused to an Fc fragment” PMID 34154614 Jun 2021

Envafolimab: 150mg, subcutaneous injection, administered on days 1, 8, and 15” NCT07266493

“PD-L1 inhibitor includes durvalumab,Atezolizumab,Adebrelimab,Envafolimab.” NCT06702566

Envafolimab: 400 mg on Day 1, repeated every 3 weeks (Q3W).” NCT07599995

“PD-L1 inhibitor,Envafolimab 400mg,d1,q3w, until PD” NCT07327411

“Drug: EnvafolimabNCT06060704

EnvafolimabNCT06618391

NCT06656559

NCT05904015

NCT05959356

NCT05360979

NCT06013943

NCT06074497

NCT05534113

NCT06041724

NCT06014372

NCT05203276

NCT06772233

NCT05213221

NCT05849311

NCT06239870

NCT06030934

NCT05055167

NCT05387681

NCT06059261

NCT05335460

NCT05941325

NCT05417230

NCT04770207

NCT06108726

NCT06218004

NCT05422183

NCT05237349

NCT05799469

NCT05298020

NCT06321081

NCT04891198

NCT07159191

NCT05529355

NCT07142863

NCT07003815

NCT05752136

NCT05858567

NCT05552651

NCT06698965

NCT05385185

NCT06959693

NCT06692491

NCT06791083

NCT05414630

NCT05828381

NCT06301828

NCT05722977

NCT05582109

NCT07243626

NCT05216653

NCT05465733

NCT05969847

NCT06055816

NCT05910034

NCT06498622

NCT05112991

NCT07559864

NCT05685550

NCT04910386

NCT05243355

NCT05551247

NCT06663007

NCT04480502

NCT05068427

NCT07256223

NCT05024214

NCT05397769

NCT06734182

NCT05448820

NCT07260305

Known as ASC22 ClinicalTrials.gov intervention name — accepted as the source's own label NCT04465890
3

NCT05129189

NCT05330143

NCT07573943

Known as Envolimab “Envafolimab indication: Envolimab is the world's first subcutaneous injection of PD-L1 monoclonal antibody.” NCT05203276
Known as KN035 “Phase I study of envafolimab (KN035), a novel subcutaneous single-domain anti-PD-L1 monoclonal antibody, in Japanese patients with advanced solid tumors.” PMID 35932387 Aug 2022
6

NCT04182789

NCT04034823

NCT03101488

NCT02827968

NCT03667170

NCT03478488

Known as KN053 “Drug: Envafolimab This product is administered by subcutaneous injection. The recommended dose of subcutaneous injection is 150 mg, administered weekly (QW). Other Name: KN053NCT05752136
Action Inhibit “Phase 1 Study of Anti-PD-L1 Monoclonal Antibody KN035 to Treat Locally Advanced or Metastatic Solid Tumors” NCT02827968
Modality Monoclonal antibody “KN035 is a monoclonal antibody drug” NCT02827968
Route Subcutaneous “formulated for subcutaneous injection” NCT02827968
Target CD274 “a PD-L1 inhibitor” NCT07283198