Envafolimab

Phase 3Monoclonal antibody

Envafolimab is a monoclonal antibody that works as a Programmed Cell Death 1 Ligand 1 Binding Agent.[2] It is being investigated across 17 indications, with its most advanced program in Phase 3.[1]

Envafolimab is one of 369 small molecule programs targeting Undifferentiated Pleomorphic Sarcoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

368

Competitors

Pipeline

Status by Indication[3][1]

Indication

Undifferentiated Pleomorphic SarcomaActive, not recruiting

Intrahepatic CholangiocarcinomaActive, not recruiting

Metastatic Colorectal CancerNot yet recruiting

Fallopian Tube CancerActive, not recruiting

Malignant Epithelial Tumor of OvaryActive, not recruiting

Colorectal CancerRecruiting

Gastric CancerRecruiting

Endometrial CancerRecruiting

Cervical CancerNot yet recruiting

TreatmentNot yet recruiting

Undifferentiated Pleomorphic SarcomaPhase 2

Active, not recruiting

Intrahepatic CholangiocarcinomaPreclinical

Active, not recruiting

Metastatic Colorectal CancerPhase 3

Not yet recruiting

Fallopian Tube CancerPreclinical

Active, not recruiting

Malignant Epithelial Tumor of OvaryPreclinical

Active, not recruiting

Colorectal CancerPhase 2

Recruiting

Gastric CancerPhase 2

Recruiting

Endometrial CancerPhase 2

Recruiting

Cervical CancerPhase 2

Not yet recruiting

TreatmentPhase 2

Not yet recruiting

Showing 10 of 17 indications

Competition

Competitive Landscape

332 competitors in Treatment

#DrugCompanyPhaseTrials

Envafolimab

TTracon Pharmaceuticals Inc.

Phase 3

1 2

Dexilant

Takeda

Preclinical

2 3

Theo-Dur

Pfizer

Preclinical

1 4

Levulan

Sun Pharmaceutical Industries, Inc.

Preclinical

1 5

Lamprene

Novartis

Preclinical

1 6

Foscavir

CClinigen, Inc.

Preclinical

6 7

Valium

Akero Therapeutics

Preclinical

2 8

Lotemax

PPharmos

Preclinical

1 9

Norpramin

VValidus Pharmaceuticals

Preclinical

1 10

Barhemsys

Tibotec Pharmaceuticals, Ireland

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Soft Tissue Sarcoma

NCT05941325

Phase 2Recruiting

Endometrial Cancer

NCT05112991

Q1 2027

Phase 1Recruiting

Advanced or Metastatic Solid Tumor

NCT07260305

Q2 2027

Phase 2Recruiting

Gastric Cancer

NCT06791083

Q3 2027

Phase 1/2Recruiting

Treatment Failure

NCT06663007

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer3 trials

A Study of Envafolimab in Subjects With Stage III Non-Small Cell Lung Cancer

Unknown status·—·Phase 2·NCT05414630·30 enrolled

A Study of Local Envafolimab Injection Combined With Chemotherapy in Non-small Cell Lung Cancer

Unknown status·NNorthern Jiangsu People's Hospital·Phase 2·NCT06108726·16 enrolled

A Prospective, Single-arm Exploratory Clinical Study of SRT Combined With Envafolimab and Endostar in the First-line Treatment of Driver Gene-negative Advanced Non-small Cell Lung Cancer With PD-L1 Positive Expression

Not yet recruiting·TThe First People's Hospital of Lianyungang·Phase 2·NCT07818304·61 enrolled

Cervical Cancer2 trials

Study of Chemoradiotherapy With Envafolimab For The Treatment of Locally Advanced Cervical Cancer

Not yet recruiting·—·Phase 2·NCT05799469·36 enrolled

Envafolimab Combined With Endostar and Concurrent Chemoradiotherapy for Locally Advanced Primary Cervical Cancer

Not yet recruiting·PPeking University Third Hospital··NCT05879796·30 enrolled

Locally Advanced2 trials

Neoadjuvant Envafolimab in Resectable and Locally Advanced MSI-H/dMMR Rectal Cancer

Not yet recruiting·FFudan University··NCT05645094·38 enrolled

Preoperative Short Course Radiotherapy With Envafolimab, Endostatin and SOX Regimen in Locally Advanced Gastric

Unknown status·UUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology·Phase 2·NCT05387681·35 enrolled

Rectal Adenocarcinoma2 trials

Total Neoadjuvant Therapy With Short-course Radiation Followed by Envafolimab Plus CAPEOX for MSS Locally Advanced Ultra Low Rectal Adenocarcinoma

Unknown status·SSir Run Run Shaw Hospital·Phase 2·NCT05858567·30 enrolled

Preoperative Short-course Radiation Followed by Envafolimab Plus CAPEOX for MSS Locally Advanced Rectal Adenocarcinoma (PRECAM)

Completed·SSir Run Run Shaw Hospital·Phase 2·NCT05216653·32 enrolled

First-line Treatment2 trials

Envafolimab as First-line Treatment of Aged Patients in Advanced NSCLC

Unknown status·TThe First Affiliated Hospital of Xiamen University·Phase 2·NCT05055167·20 enrolled

Envafolimab Combined With Endostar in the First-line Treatment of Advanced NSCLC

Unknown status·TThe First People's Hospital of Lianyungang·Phase 2·NCT05203276·40 enrolled

27 more indications

Colorectal Cancer2 trials

Envafolimab Monotherapy or Envafolimab + CAPEOX as Neoadjuvant Therapy for Locally Advanced Colorectal Cancer

Recruiting·SSun Yat-sen University·Phase 2·NCT06014372·55 enrolled

Envafolimab Combined With Endostatin in Recurrent or Metastatic MSS-type Colorectal Cancer

Unknown status·FFirst Affiliated Hospital Xi'an Jiaotong University·Phase 2·NCT05551247·30 enrolled

Gastric Adenocarcinoma1 trial

Envafolimab Combined With Chemotherapy in Metastatic or Recurrent Gastric Adenocarcinoma

Unknown status·LLiangjun Zhu M.M.·Phase 2·NCT05237349·38 enrolled

Treatment Failure1 trial

RC48 Monotherapy or Combination With Envafolimab for CDK12 Alterations mCRPC With Standard Treatment Failure

Recruiting·TTianjin Medical University Second Hospital·Phase 1/2·NCT06663007·72 enrolled

Fallopian Tube Cancer1 trial

A Prospective, Randomized Controlled Study of Cyclophosphamide, Bevacizumab With or Without Envafolimab in Recurrent Epithelial Ovarian Cancer (EOC), Fallopian Tube Cancer, and Primary Peritoneal Cancer

Not yet recruiting·HHebei Medical University Fourth Hospital··NCT06010667·60 enrolled

Metastatic Sarcoma1 trial

YH001 Plus Envafolimab With or Without Doxorubicin in Patients With Advanced or Metastatic Sarcoma

Unknown status·TTracon Pharmaceuticals Inc.·Phase 1/2·NCT05448820·15 enrolled

Advanced NSCLC1 trial

Trial of Chidamide in Combination With Envafolimab in Patients With PD-1 Inhibitor Resistant Advanced NSCLC.

Completed·CChipscreen Biosciences, Ltd.·Phase 2·NCT05068427·34 enrolled

Esophageal Cancer1 trial

Envafolimab Combined With Abraxane and Cisplatinas as Neoadjuvant Treatment for Resectable Esophageal Cancer

Unknown status·FFujian Medical University Union Hospital·Phase 2·NCT05828381·33 enrolled

Ovarian Cancer1 trial

Envafolimab, Lenvatinib Combined With VP-16 in Platinum-resistant Recurrent Epithelial Ovarian Cancer

Unknown status·ZZhongda Hospital·Phase 2·NCT05422183·20 enrolled

Anti-angiogenic Therapy1 trial

A Clinical Study of Immunotherapy Combined With Chemotherapy and Anti-angiogenic Therapy in Operable NSCLC

Unknown status·SSecond Xiangya Hospital of Central South University·Phase 2·NCT05360979·42 enrolled

Systemic Therapy1 trial

Local Injection and Systemic Therapy in the Treatment of NSCLC.

Not yet recruiting·HHenan Cancer Hospital·Phase 2·NCT06618391·84 enrolled

Bevacizumab1 trial

Envafolimab Combined With Trifluridine/Tipiracil and Bevacizumab in the Treatment of Refractory mCRC.

Unknown status·TThe First Affiliated Hospital with Nanjing Medical University·Phase 2·NCT06060704·33 enrolled

Gastrointestinal Tumors1 trial

Endostar Combined With SBRT and Envafolimab in the Treatment of Advanced Gastrointestinal Tumors

Unknown status·NNanjing First Hospital, Nanjing Medical University·Phase 2·NCT06301828·16 enrolled

Advanced or Metastatic Solid Tumor1 trial

A Phase I Study to Investigate the Safety and Tolerability of KGX101 Monotherapy and Combination Therapy With Envafolimab in Advanced or Metastatic Solid Tumor Patients

Recruiting·KKangabio AUSTRALIA LTD PTY·Phase 1·NCT07260305·57 enrolled

Soft Tissue Sarcoma1 trial

A Single-arm, Open-label, Single-center Prospective Study of Fruquintinib Combined With Envafolimab in the Treatment of Advanced or Unresectable Locally Advanced Bone and Soft Tissue Sarcoma

Recruiting·SShanghai 6th People's Hospital·Phase 2·NCT05941325·20 enrolled

Endometrial Cancer1 trial

Study of Envafolimab Alone or With Lenvatinib in Patients With Advanced Endometrial Cancer

Recruiting·33D Medicines (Sichuan) Co., Ltd.·Phase 2·NCT05112991·108 enrolled

Metastatic Colorectal Cancer1 trial

A Clinical Study to Evaluate the Efficacy and Safety of Envafolimab Combined With Cetuxima-βand mFOLFOX6 in Patients With MSS, RAS/BRAF Wild-Type Metastatic Colorectal Cancer (mCRC)

Not yet recruiting·SSun Yat-sen University·Phase 2/3·NCT06959693·590 enrolled

Biliary Tract Cancer1 trial

RC48-ADC Combinatioed Envolizumab in Locally Advanced or Metastatic Biliary Tract Cancer With Positive HER-2

Unknown status·JJiangsu Cancer Institute & Hospital·Phase 2·NCT05417230·29 enrolled

Esophageal Squamous Cell Carcinoma1 trial

Envafolimab Combined With Chemotherapy in Neoadjuvant Therapy for Resectable Esophageal Squamous Cell Carcinoma

Unknown status·TTao Jiang·Phase 2·NCT05552651·40 enrolled

Treatment1 trial

Study of Precision Treatment for Rare Tumours in China Guided by PDO and NGS

Not yet recruiting·PPeking University Shenzhen Hospital·Phase 2·NCT06692491·200 enrolled

Gastric Cancer1 trial

Clinical Study of Envafolimab Combined With Fruquintinib and Chemotherapy for Neoadjuvant Treatment of Gastric Cancer

Recruiting·FFirst Affiliated Hospital of Fujian Medical University·Phase 2·NCT06791083·40 enrolled

Patients With Advanced Solid Tumors1 trial

ENVAFOLIMAB Single-agent Treatment in Patients With Advanced Solid Tumors

Recruiting·33D Medicines (Sichuan) Co., Ltd.·Phase 2·NCT04891198·126 enrolled

Total Neoadjuvant Therapy1 trial

Organ Preservation Following Enverolimab-based Total Neoadjuvant Therapy for Locally Advanced Very Low Rectal Cancer

Not yet recruiting·UUnknown Sponsor·Phase 2·NCT05969847·72 enrolled

Locally Advanced Colon Cancer1 trial

To Determine the Efficacy and Safety of Envafolimab Combined With XELOX for Locally Advanced Colon Cancer

Unknown status·FFujian Cancer Hospital·Phase 2·NCT05335460·36 enrolled

Undifferentiated Pleomorphic Sarcoma1 trial

ENVASARC: Envafolimab And Envafolimab With Ipilimumab In Patients With Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma

Active, not recruiting·TTracon Pharmaceuticals Inc.·Phase 2·NCT04480502·207 enrolled

Envafolimab1 trial

Study on Therapeutic Effect of Combination of Envafolimab, Lenavatinib and TACE in Advanced HCC Patients

Completed·ZZhejiang University·Phase 2·NCT05213221·39 enrolled

Pancreatic Cancer1 trial

Envafolimab Combined With Endostar and Chemotherapy for First-line Treatment of Advanced Pancreatic Cancer

Unknown status·TThe Affiliated Hospital of Xuzhou Medical University·Phase 2·NCT05298020·20 enrolled

Rectal Cancer1 trial

Preoperative Short-course Radiation Followed by Envafolimab Plus CAPEOX for MSS Locally Advanced Rectal Adenocarcinoma: a Prospective, Multicenter, Randomized Controlled Study (PRECAM-R)

Recruiting·SSir Run Run Shaw Hospital·Phase 3·NCT05752136·108 enrolled

Sources

References

[1]
ClinicalTrials.gov — 39 trial records for Envafolimab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Envafolimab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Envafolimab. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Tracon Pharmaceuticals Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Programmed Cell Death 1 Ligand 1 Binding Agent[2]
Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: TTracon Pharmaceuticals Inc.

Envafolimab

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Q3 2027

Trials by Indication[1]

Non-Small Cell Lung Cancer3 trials

Cervical Cancer2 trials

Locally Advanced2 trials

Rectal Adenocarcinoma2 trials

First-line Treatment2 trials

Colorectal Cancer2 trials

Gastric Adenocarcinoma1 trial

Treatment Failure1 trial

Fallopian Tube Cancer1 trial

Metastatic Sarcoma1 trial

Advanced NSCLC1 trial

Esophageal Cancer1 trial

Ovarian Cancer1 trial

Anti-angiogenic Therapy1 trial

Systemic Therapy1 trial

Bevacizumab1 trial

Gastrointestinal Tumors1 trial

Advanced or Metastatic Solid Tumor1 trial

Soft Tissue Sarcoma1 trial

Endometrial Cancer1 trial

Metastatic Colorectal Cancer1 trial

Biliary Tract Cancer1 trial

Esophageal Squamous Cell Carcinoma1 trial

Treatment1 trial

Gastric Cancer1 trial

Patients With Advanced Solid Tumors1 trial

Total Neoadjuvant Therapy1 trial

Locally Advanced Colon Cancer1 trial

Undifferentiated Pleomorphic Sarcoma1 trial

Envafolimab1 trial

Pancreatic Cancer1 trial

Rectal Cancer1 trial

References

Drug Info

Quick Facts

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