Balstilimab

Summary

Balstilimab (CHEMBL4297877) is a phase-3 clinical-stage antibody; indicated across 19 conditions including soft tissue sarcoma and urinary bladder neoplasm.

At a glance

• Status: Max clinical phase 3 (not approved)
• Modality: Antibody
• Indications: 19 conditions
• Clinical trials: 50

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL4297877
Name	Balstilimab
Type	Antibody
Max phase	3

Also known as: AGEN-2034, Agen2034, AGEN2034, Balstilimab, BALSTILIMAB

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

19 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
soft tissue sarcoma	2	MONDO:0018078	EFO:1001968
urinary bladder neoplasm	2	MONDO:0004987	EFO:0000294
angiosarcoma	2	MONDO:0016982	EFO:0003968
melanoma	2	MONDO:0005105	EFO:0000756
human papilloma virus infection	2	MONDO:0005161	EFO:0001668
oropharynx cancer	2	MONDO:0004608	EFO:1001931
lymphoma	2	MONDO:0005062	EFO:0000574
exocrine pancreatic carcinoma	2	MONDO:0005192	EFO:0002618
colorectal neoplasm	2	MONDO:0005335	EFO:0004142
renal cell carcinoma	2	MONDO:0005086	EFO:0000681
pancreatic ductal adenocarcinoma	2	MONDO:0005184	MONDO:0005184
neoplasm	1	MONDO:0005070	EFO:0000616
diffuse intrinsic pontine glioma	1	MONDO:0006033	EFO:1000026
non-small cell lung carcinoma	1	MONDO:0005233	EFO:0003060
ovarian cancer	1	MONDO:0008170	MONDO:0008170
endometrium neoplasm	1	MONDO:0021251	MONDO:0011962

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

Clinical trials

Total trials: 50.

Phase distribution

Phase	Trials
PHASE2	28
PHASE1	8
PHASE1/PHASE2	7
PHASE3	3
EARLY_PHASE1	2
PHASE2/PHASE3	1
Not specified	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT06279130	PHASE2/PHASE3	RECRUITING	Pan-tumor Neoadjuvant Basket Study of Immune Check-point Inhibition and Novel Immuno-oncology Combinations
NCT06346197	PHASE3	RECRUITING	Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas
NCT07152821	PHASE3	RECRUITING	Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcinoma
NCT04943627	PHASE3	WITHDRAWN	Balstilimab Versus Investigator Choice Chemotherapy in Patients With Recurrent Cervical Cancer (BRAVA)
NCT04028063	PHASE2	ACTIVE_NOT_RECRUITING	Doxorubicin Plus Dual Checkpoint Blockade for Soft Tissue Sarcomas
NCT05205330	PHASE1/PHASE2	ACTIVE_NOT_RECRUITING	Vorbipiprant (CR6086) / Balstilimab (AGEN2034) Combination in Stage IV Refractory pMMR - MSS CRC, and Other Metastatic GI Cancers
NCT05529316	PHASE2	ACTIVE_NOT_RECRUITING	A Study of Botensilimab (AGEN1181) for the Treatment of Advanced Melanoma
NCT05571293	PHASE2	ACTIVE_NOT_RECRUITING	Combination Immunotherapy in Colorectal Cancer
NCT05608044	PHASE2	ACTIVE_NOT_RECRUITING	A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
NCT05627635	PHASE1/PHASE2	ACTIVE_NOT_RECRUITING	FOLFOX and Bevacizumab in Combination With Botensilimab and Balstilimab (3B-FOLFOX) for the Treatment of Microsatellite Stable (MSS) Metastatic Colorectal Cancer
NCT05638698	PHASE2	ACTIVE_NOT_RECRUITING	Tg01 Vaccine / Qs-21 Stimulon™ With Or Without Balstilimab As Maintenance Therapy Following Adjuvant Chemotherapy In Patients With Resected Pancreatic Cancer
NCT05672316	PHASE1/PHASE2	ACTIVE_NOT_RECRUITING	Botensilimab, Balstilimab and Regorafenib for the Treatment of Patients With Microsatellite Stable Metastatic Colorectal Cancer Who Have Progressed on Prior Chemotherapy
NCT05845450	PHASE2	RECRUITING	Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN)
NCT05864534	PHASE2	RECRUITING	Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma
NCT05891821	PHASE2	RECRUITING	Assessment of the Safety and Efficacy of Balstilimab for the Treatment of Relapsed/Refractory Lymphomas (IMMONC0001)
NCT06251973	PHASE2	ACTIVE_NOT_RECRUITING	A Study of agenT-797 in Combination With Botensilimab, Balstilimab, Ramucirumab, and Paclitaxel for People With Esophageal, Gastric, or Gastro-esophageal Junction Cancer
NCT06268015	PHASE2	ACTIVE_NOT_RECRUITING	Botensilimab and Balstilimab Optimization in Colorectal Cancer
NCT06300463	PHASE2	RECRUITING	Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases
NCT06322108	PHASE2	RECRUITING	Assessment of the Safety and Efficacy of Balstilimab in Combination With Botensilimab for the Treatment of Non-Small Cell Lung Cancer (IMMONC0008)
NCT06780787	PHASE2	RECRUITING	FOLFOX, Botensilimab, and Balstilimab for the Treatment of Localized Rectal Cancer Before Surgery
NCT06782555	PHASE1/PHASE2	RECRUITING	A Study of Evofosfamide in Combination with Zalifrelimab and Balstilimab
NCT06782932	PHASE1/PHASE2	RECRUITING	Comparing Neoadjuvant/Adjuvant GVAX vs a mKRASvax Given With Anti-PD-1 and Anti-CD137 for Surgically Resectable Pancreatic Cancer
NCT06843434	PHASE2	RECRUITING	A Study of Botensilimab and Balstilimab for Rectal Adenocarcinoma
NCT06843551	PHASE2	RECRUITING	The Miami EMPIRE Trial - Eradication of Metastatic Pancreatic Cancer With Immuno-Radiation
NCT07227636	PHASE2	RECRUITING	A Study of Botensilimab and Balstilimab for Colorectal Cancer With ctDNA+ After Surgery and Chemotherapy
NCT07516366	PHASE2	NOT_YET_RECRUITING	Testing the Safety and Feasibility of Immunotherapy Drugs, Botensilimab and Balstilimab, Before Surgery for Clear Cell Renal Cell Carcinoma, NEO RoBOT Trial
NCT07550088	PHASE2	NOT_YET_RECRUITING	BAL/BOT/agenT-797 in pMMR CRC With Liver Metastases
NCT07551596	PHASE2	NOT_YET_RECRUITING	Testing the Combination of Anti-Cancer Drugs, Botensilimab (AGEN1181) and Balstilimab (AGEN2034), After Standard Treatment for Colorectal Cancer, Combat Trial
NCT07595874	PHASE2	NOT_YET_RECRUITING	Neoadjuvant Botensilimab and Balstilimab for the Treatment of Advanced Resectable Colorectal Cancer NEST3
NCT03104699	PHASE1/PHASE2	COMPLETED	A Study of AGEN2034 in Advanced Tumors and Cervical Cancer
NCT03495882	PHASE1/PHASE2	COMPLETED	Subjects With Metastatic or Locally Advanced Solid Tumors, and Expansion Into Select Solid Tumors (Cervical)
NCT03894215	PHASE2	TERMINATED	RaPiDS- A Phase 2 Study of Anti-PD-1 Independently or in Combination With Anti-CTLA-4 in Second-Line Cervical Cancer
NCT04430036	PHASE2	TERMINATED	AGEN1884 Plus AGEN2034 Combined With Cisplatin-Gemcitabine for Muscle-Invasive Bladder Cancer
NCT04607200	PHASE2	WITHDRAWN	AGEN2034 & AGEN1884 in Patients With Recurrent, Inoperable Angiosarcoma
NCT05033132	PHASE2	WITHDRAWN	A Phase II Study of Balstilimab Independently or in Combination With Zalifrelimab in Advanced Cervical Cancer
NCT05363709	PHASE2	WITHDRAWN	BALSTILIMAB on Viral Clearance in HPV+ Oropharyngeal Cancer Patients
NCT05561491	PHASE2	WITHDRAWN	A Study of ONCOS-102 in Combination With Other Novel Immune-therapies in Advanced Treatment-resistant Melanoma Patients
NCT05928806	PHASE2	SUSPENDED	Advanced Renal Cell Cancer Combination ImmunoThErapy Clinical Trial
NCT06575725	PHASE2	WITHDRAWN	Botensilimab, Balstilimab and Regorafenib or Botensilimab and Balstilimab for the Treatment of Advanced or Metastatic Microsatellite Stable Colorectal Cancer
NCT03860272	PHASE1	ACTIVE_NOT_RECRUITING	Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced 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).