Envafolimab

Summary

Envafolimab (CHEMBL4298006) is a phase-3 clinical-stage antibody; indicated across 30 conditions including rectal cancer and hepatocellular carcinoma.

At a glance

• Status: Max clinical phase 3 (not approved)
• Modality: Antibody
• Indications: 30 conditions
• Clinical trials: 67

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL4298006
Name	Envafolimab
Type	Antibody
Max phase	3

Also known as: ASC-22, Asc22, ASC22, Envafolimab, Kn 035, KN-035, Kn035, KN035, ENVAFOLIMAB

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

30 indications (0 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
rectal cancer	3	MONDO:0006519	EFO:1000657
hepatocellular carcinoma	2	MONDO:0007256	EFO:0000182
neoplasm	2	MONDO:0005070	EFO:0000616
breast neoplasm	2	MONDO:0021100	MONDO:0007254
chronic hepatitis B virus infection	2	MONDO:0005366	EFO:0004239
biliary tract neoplasm	2	MONDO:0005304	EFO:0003891
HIV infectious disease	2	MONDO:0005109	EFO:0000180
gastric adenocarcinoma	2	MONDO:0005036	EFO:0000503
non-small cell lung carcinoma	2	MONDO:0005233	EFO:0003060
nasopharyngeal neoplasm	2	MONDO:0005375	EFO:0004252
soft tissue sarcoma	2	MONDO:0018078	EFO:1001968
ovarian cancer	2	MONDO:0008170	MONDO:0008170
endometrium neoplasm	2	MONDO:0021251	MONDO:0011962
colonic neoplasm	2	MONDO:0005401	MONDO:0021063
lung neoplasm	2	MONDO:0021117	MONDO:0021117
colorectal neoplasm	2	MONDO:0005335	EFO:0004142
esophageal squamous cell carcinoma	2	MONDO:0005580	EFO:0005922
malignant pancreatic neoplasm	2	MONDO:0009831	EFO:1000359
sarcoma	2	MONDO:0005089	EFO:0000691
adenocarcinoma	2	MONDO:0004970	MONDO:0003219
gallbladder neoplasm	2	MONDO:0021253	MONDO:0005411
nasopharyngeal carcinoma	2	MONDO:0015459	MONDO:0015459

8 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 67.

Phase distribution

Phase	Trials
PHASE2	53
PHASE1	5
Not specified	4
PHASE1/PHASE2	3
PHASE3	1
PHASE2/PHASE3	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT05752136	PHASE3	RECRUITING	Preoperative Short-course Radiation Followed by Envafolimab Plus CAPEOX for MSS Locally Advanced Rectal Adenocarcinoma
NCT06959693	PHASE2/PHASE3	NOT_YET_RECRUITING	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)
NCT03667170	PHASE2	RECRUITING	KN035 for dMMR/MSI-H Advanced Solid Tumors
NCT04480502	PHASE2	ACTIVE_NOT_RECRUITING	ENVASARC: Envafolimab And Envafolimab With Ipilimumab In Patients With Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma
NCT04891198	PHASE2	RECRUITING	ENVAFOLIMAB Single-agent Treatment in Patients With Advanced Solid Tumors
NCT05024214	PHASE1/PHASE2	RECRUITING	Phase Ib/II Trial of Envafolimab Plus Lenvatinib for Subjects With Solid Tumors
NCT05112991	PHASE2	RECRUITING	Study of Envafolimab Alone or With Lenvatinib in Patients With Advanced Endometrial Cancer
NCT05722977	PHASE2	NOT_YET_RECRUITING	Surufatinib and Envafolimab as Second or More-line Therapy in Advanced Soft Tissue Sarcoma Patients
NCT05799469	PHASE2	NOT_YET_RECRUITING	Study of Chemoradiotherapy With Envafolimab For The Treatment of Locally Advanced Cervical Cancer
NCT05910034	PHASE2	NOT_YET_RECRUITING	Envafolimab Plus Docetaxel In Combination With or Without Trilaciclib Versus Docetaxel in Advanced NSCLC
NCT05959356	PHASE2	RECRUITING	Cetuximab and Envafolimab Plus mFOLFOXIRI as First-line Treatment for RAS/BRAF Wild-type, MSS, Unresectable Left-side Metastatic Colorectal Cancer
NCT05969847	PHASE2	NOT_YET_RECRUITING	Organ Preservation Following Enverolimab-based Total Neoadjuvant Therapy for Locally Advanced Very Low Rectal Cancer
NCT06014372	PHASE2	RECRUITING	Envafolimab Monotherapy or Envafolimab + CAPEOX as Neoadjuvant Therapy for Locally Advanced Colorectal Cancer
NCT06055816	PHASE2	RECRUITING	Gemcitabine Combined With Endostar and Envafolimab in Elderly Patients With Locally Advanced Nasopharyngeal Carcinoma
NCT06059261	PHASE2	RECRUITING	Envafolimab Combined With Chemoradiotherapy and Recombinant Human Endostatin for LA-NPC.
NCT06321081	PHASE2	RECRUITING	ICE Study: Combination of Irinotecan Plus Cetuximab and Envafolimab as a Rechallenge Regimen in mCRC
NCT06498622	PHASE2	RECRUITING	Adjuvant Treatment of Patients With High Risk of Recurrent Hepatocellular Carcinoma With Donafenib in Combination With Envafolimab
NCT06618391	PHASE2	NOT_YET_RECRUITING	Local Injection and Systemic Therapy in the Treatment of NSCLC.
NCT06656559	PHASE2	NOT_YET_RECRUITING	Endoscopic Retrograde Cholangiopancreatography With Radiofrequency Ablation (ERCP-RFA) Combined With Envafolimab and Surufatinib Sequential Therapy for Unresectable Biliary Tract Carcinoma
NCT06663007	PHASE1/PHASE2	RECRUITING	RC48 Monotherapy or Combination With Envafolimab for CDK12 Alterations mCRPC With Standard Treatment Failure
NCT06692491	PHASE2	NOT_YET_RECRUITING	Study of Precision Treatment for Rare Tumours in China Guided by PDO and NGS
NCT06791083	PHASE2	RECRUITING	Clinical Study of Envafolimab Combined With Fruquintinib and Chemotherapy for Neoadjuvant Treatment of Gastric Cancer
NCT07003815	PHASE2	NOT_YET_RECRUITING	Envafolimab With Chemotherapy and Simvastatin in Advanced Biliary Tract Cancer
NCT07142863	PHASE2	NOT_YET_RECRUITING	Envafolimab Combined With Neoadjuvant Chemotherapy Treat Stage IIb Resectable Osteosarcoma Patients
NCT07256223	PHASE2	NOT_YET_RECRUITING	A Clinical Trial of Envafolimab Combined With Lenvatinib for Kidney Cancer With Liver Spread
NCT07559864	PHASE2	RECRUITING	Comparing Regorafenib Combined With Envafolimab to Physician’s Choice in Patients With Metastatic Gastrointestinal Stromal Tumors Harboring KIT Exon 17 Mutations Refractory to Standard Treatment
NCT04034823	PHASE2	UNKNOWN	KN035 in Combination With Trastuzumab and Docetaxel in HER2-positive Breast Cancer
NCT04182789	PHASE2	UNKNOWN	KN035 in Patients With Advanced Multiple Primary Tumors
NCT04465890	PHASE2	COMPLETED	A Phase II Study of Subcutaneously Injected PD-L1 Antibody ASC22 in Chronic Hepatitis B Patients
NCT05055167	PHASE2	UNKNOWN	Envafolimab as First-line Treatment of Aged Patients in Advanced NSCLC
NCT05068427	PHASE2	COMPLETED	Trial of Chidamide in Combination With Envafolimab in Patients With PD-1 Inhibitor Resistant Advanced NSCLC.
NCT05129189	PHASE2	UNKNOWN	Functional Cure Study of Anti-PD-L1 Antibody ASC22 in Combination With Chidamide in HIV-infected Patients With Antiviral Suppression
NCT05203276	PHASE2	UNKNOWN	Envafolimab Combined With Endostar in the First-line Treatment of Advanced NSCLC
NCT05213221	PHASE2	COMPLETED	Study on Therapeutic Effect of Combination of Envafolimab, Lenavatinib and TACE in Advanced HCC Patients
NCT05216653	PHASE2	COMPLETED	Preoperative Short-course Radiation Followed by Envafolimab Plus CAPEOX for MSS Locally Advanced Rectal Adenocarcinoma (PRECAM)
NCT05237349	PHASE2	UNKNOWN	Envafolimab Combined With Chemotherapy in Metastatic or Recurrent Gastric Adenocarcinoma
NCT05243355	PHASE2	UNKNOWN	Envafolimab Combined With Chemotherapy and Recombinant Human Endostatin in the First-line Treatment of Sq-NSCLC
NCT05298020	PHASE2	UNKNOWN	Envafolimab Combined With Endostar and Chemotherapy for First-line Treatment of Advanced Pancreatic Cancer
NCT05330143	PHASE2	COMPLETED	Study to Evaluate Safety, Tolerance and Efficacy of ASC22 Combined With ART in Subjects With HIV
NCT05335460	PHASE2	UNKNOWN	To Determine the Efficacy and Safety of Envafolimab Combined With XELOX for Locally Advanced Colon Cancer

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).