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Botensilimab+ Balstilimab

Phase 2

Non-small Cell Lung Cancer | Small molecule | Oncology |Agenus Inc.|Last Updated: Jun 8, 2026

Target and mechanism

Target class-Mab (Antibody)
ModalitySmall molecule

Also known as Botensilimab, botensilimab

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment45

FDA Designations

FAST_TRACK

Clinical trial landscape

Botensilimab+ Balstilimab · 1 trial · 1 indication

Phase 2 1
NCT06322108Assessment of the Safety and Efficacy of Balstilimab in Combination With Botensilimab for the Treatment of Non-Small Cell Lung Cancer (IMMONC0008)Non-small Cell Lung Cancer
ACTIVE NOT_RECRUITING45 Analytics
PHASE2ACTIVE NOT_RECRUITING
Assessment of the Safety and Efficacy of Balstilimab in Combination With Botensilimab for the Treatment of Non-Small Cell Lung Cancer (IMMONC0008)
Non-small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

12-Month Progression-Free Survival (PFS)
First dose to up to 12 months

12-Month PFS is defined as the proportion of patients who remain alive and progression-free at 12 months from the first dose of investigational drug, where tumor progression is documented per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) and modified Response Evaluation Criteria in Solid Tumors version 1.1 for immune-based therapeutics (iRECIST) as assessed by investigator.

Secondary Endpoints

Objective Response Rate (ORR)
First dose to up to 6 months
Disease Control Rate (DCR)
First dose to up to 6 months
Duration of Response (DOR)
First dose to up to 48 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Botensilimab + BalstilimabEXPERIMENTALbotensilimab 75 mg IV every 6 weeks (up to 4 doses) + balstilimab 240 mg IV every 2 weeks

Interventions

NameTypeDescription
Botensilimab + BalstilimabDRUGBotensilimab is a fragment crystallizable (Fc)-engineered human immunoglobulin G1 (IgG1) monoclonal antibody that targets cytotoxic T lymphocyte-associated protein 4 (CTLA-4). Balstilimab is a human monoclonal antibody that targets programmed cell death protein 1 (PD-1).
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Histologically and IHC confirmed diagnosis of metastatic NSCLC which has not received any prior anticancer medicinal therapy for metastatic disease. 2. Negative for actionable EGFR mutations and ALK rearrangements. 3. Patients with recurrence after prior neoadjuvant or adjuva...

Countries:Armenia
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Competitive Landscape -Non-Small Cell Lung Cancer 389 trials

Recent Changes (Last 90 Days)

MEDIUMJun 8, 2026NCT06322108Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 8, 2026NCT06322108Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 8, 2026NCT06322108Status: RECRUITING → ACTIVE_NOT_RECRUITING

Frequently asked questions about Botensilimab+ Balstilimab

What is Botensilimab used for?

Botensilimab is an investigational antibody being studied for the treatment of several cancers, including non-small cell lung cancer, metastatic colorectal cancer, metastatic pancreatic ductal adenocarcinoma, early rectal cancer, and advanced cancer. It is being developed by Agenus Inc. and is currently in Phase 1 clinical trials.

What does Botensilimab target?

Botensilimab is a monoclonal antibody, indicated by its -mab suffix. As an antibody, it is designed to bind to specific targets involved in cancer. However, the specific molecular target has not been disclosed in the available information.

Who makes Botensilimab?

Botensilimab is being developed by Agenus Inc., a biopharmaceutical company. Agenus is publicly traded under the ticker symbol AGEN. The company is conducting clinical trials to evaluate Botensilimab for various oncology indications.

What phase is Botensilimab in?

Botensilimab is currently in Phase 1 clinical development. It has received Fast Track designation from the FDA. Botensilimab is investigational and has not been approved by the FDA for any indication.

What clinical trials is Botensilimab in?

Botensilimab is being studied in several clinical trials, including NCT05529316 for advanced melanoma, NCT05608044 for metastatic colorectal cancer, NCT06076837 for metastatic pancreatic cancer, and NCT06268015 for colorectal cancer. These trials are in Phase 1 or Phase 2 and are active but not recruiting.

Is Botensilimab the same as Botensilimab plus Balstilimab?

Botensilimab is sometimes studied in combination with balstilimab, another investigational antibody. The combination is referred to as Botensilimab plus Balstilimab. Clinical trials such as NCT05608044 and NCT06268015 are evaluating this combination for colorectal cancer.