Assessment of the Safety and Efficacy of Balstilimab in Combination With Botensilimab for the Treatment of Non-Small Cell Lung Cancer (IMMONC0008)

NCT06322108 | Recruiting Phase 2 FDA Drug

• 1 other identifier: IMMONC0008
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to see if the combination of immunotherapy agents botensilimab and balstilimab is safe and effective in participants with metastatic non-small cell lung cancer (NSCLC) as a first-line treatment.

Conditions

Non-small Cell Lung Cancer

Keywords

Immunotherapy; Cancer; NSCLC

Outcome Measures

Primary Outcomes (1)

• 12-Month Progression-Free Survival (PFS)

  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.

  First dose to up to 12 months

Secondary Outcomes (14)

• 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

• Time to Next Treatment (TTNT)

  First dose to up to 48 months

• Overall Survival (OS) Time

  First dose to up to 48 months

Study Arms (1)

Botensilimab + Balstilimab

EXPERIMENTAL

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

Drug: Botensilimab + Balstilimab

Interventions

Botensilimab + Balstilimab DRUG

Botensilimab 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).

Also known as: AGEN1181 + AGEN2034

Botensilimab + Balstilimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically and IHC confirmed diagnosis of metastatic NSCLC which has not received any prior anticancer medicinal therapy for metastatic disease.
• Negative for actionable EGFR mutations and ALK rearrangements.
• Patients with recurrence after prior neoadjuvant or adjuvant chemotherapy or radiation therapy or immune checkpoint inhibitors for non-metastatic disease are eligible if recurrence occurred \>6 months after the end of neoadjuvant or adjuvant treatment.
• Documented informed consent of the participant and/or legally authorized representative
• ≥ 18 years of age.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy ≥ 3 months.
• Patients should have measurable metastatic disease as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and iRECIST guidelines.
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (within 7 days prior to day 1 of protocol therapy) (except subjects with Gilbert syndrome who must have a total bilirubin level of ≤3.0 × ULN).
• Aspartate aminotransferase (AST) ≤ 2.5 x ULN, unless presence of liver metastases for which ≤ 5 x ULN is allowed (within 7 days prior to day 1 of protocol therapy).
• Alanine aminotransferase (ALT) ≤ 2.5 x ULN, unless presence of liver metastases for which ≤ 5 x ULN is allowed (within 7 days prior to day 1 of protocol therapy).
• Creatinine clearance ≥ 45 ml/min (within 7 days prior to day 1 of protocol therapy).
• Alkaline phosphatase ≤ 3 x ULN (within 7 days prior to day 1 of protocol therapy).
• Hemoglobin ≥ 9 g/dl (within 7 days prior to day 1 of protocol therapy).
• Absolute neutrophil count (ANC) ≥ 1500/ul (within 7 days prior to day 1 of protocol therapy).

You may not qualify if:

• Prior treatment with anti-CTLA-4 and anti-PD-(L)1 therapy. Note: Prior treatment with anti-PD-(L)1 therapy in the adjuvant setting is permitted if recurrence occurred \>6 months after the end of adjuvant treatment.
• Patients with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) within 14 days or another immunosuppressive medication within 30 days of the first dose of study treatment. Inhaled or topical steroids, and adrenal replacement steroid dose ≤ 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
• Prior allogeneic organ transplantation.
• Surgical intervention within 4 weeks prior to study treatment, except for minor procedures such as port placement.
• Prior allergic reaction or hypersensitivity to any of the study drug components.
• Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years before starting treatment, i.e., with use of disease-modifying agents or immunosuppressive drugs.
• Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥ III), serious uncontrolled cardiac arrhythmia requiring medication.
• a. QTcF (QTc interval corrected using Fridericia's formula) of \> 480 ms.
• Any persistent toxicities (Common Terminology Criteria for Adverse Events \[CTCAE\] grade ≥ 2) from prior cancer therapy, excluding endocrinopathies stable on medication, stable neuropathy that is grade 2 or less, and alopecia.
• Active brain metastases or leptomeningeal metastases with the following exceptions:
• a. Treated brain metastases require a) surgical resection, or b) stereotactic radiosurgery. Whole-brain radiation is not allowed. Subjects must have also discontinued steroid treatment 28 days prior to enrollment for the purpose of managing their brain metastases and they must be asymptomatic and radiologically stable ≥28 days before enrollment.
• Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 730 days (or 2 years) prior to enrollment, i.e., subjects with a history of prior malignancy are eligible if treatment was completed at least 730 days (or 2 years) before enrollment and the subject has no evidence of disease. Subjects with history of prior early-stage basal/squamous cell skin cancer, low-risk prostate cancer eligible for active surveillance or noninvasive or in situ cancers who have undergone definitive treatment at any time are also eligible.
• Any evidence of current interstitial lung disease (ILD) or pneumonitis, or prior history of ILD or non-infectious pneumonitis requiring glucocorticoids.
• Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
• History or current evidence of any condition, co-morbidity, therapy, any active infections, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.

Sponsors & Collaborators

• Immune Oncology Research Institute: lead
• Agenus Inc.: collaborator

Study Sites (1)

Hematology Center named after prof. R. Yeolyan

Yerevan, 0014, Armenia

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasms

Interventions

balstilimab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Gevorg Tamamyan, MD, PhD, DSc

  Immune Oncology Research Institute

  STUDY DIRECTOR

• Samvel Bardakhchyan, MD, PhD

  Immune Oncology Research Institute

  STUDY CHAIR

• Samvel Bardakhchyan, MD, PhD

  Immune Oncology Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samvel Bardakhchyan, MD, PhD

CONTACT

+374 (010) 283800; samvelbardakhchyan@gmail.com

Amalya Sargsyan, MD

CONTACT

+374 (10) 283800; amalyasargsyan@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 20, 2024
• Study Start: June 13, 2024
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)