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Also known as Balstilmab, BAL, AGEN2034
Balstilimab · 8 trials · 20 indications
Comparison of survival of patients under Botensilimab + Balstilimab versus the standard of care FOLFOX/XELOX + nivolumab
Unacceptable toxicity rate in cycle 1 of \< 33%
Overall survival and progression-free survival at 12 and 18 months, as well as median progression-free and overall survival.
ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) assessed per the Lugano criteria
Determine the progression-free survival rate at 6 months of combination therapy with doxorubicin, AGEN1884, and AGEN2034 in anthracycline-naïve patients with advanced or metastatic soft tissue sarcomas.
Phase 1: To determine the recommended phase 2 dose of ivermectin in combination with balstilimab or pembrolizumab using NCI-CTCAE v5.0
Phase 2: To determine the efficacy of ivermectin in combination with balstilimab or pembrolizumab in mTNBC using the objective response rate (ORR)
Incidence of TEAEs using NCI CTCAE v5.0
Proportion of patients who have achieved CR, PR, or stable disease (SD) per RECIST 1.1 / iRECIST during the Dose Escalation part
A DLT was defined as any treatment-related toxicity that was National Cancer Institute Common Terminology Criteria for Adverse Event Grade ≥3, confirmed by the safety monitoring committee to be relevant for the study drug treatment, and that occurred during the first 3 weeks of balstilimab treatment in the dose escalation portion of the study (DLT evaluation period).
An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which did not necessarily have a causal relationship with the treatment. TEAEs were AEs with onset dates during the on-treatment period, or the worsening of an event during the on-treatment period. A summary of all Serious Adverse Events and Other Adverse Events (nonserious), regardless of causality, is located in the 'Reported Adverse Events' Section.
ORR was defined as percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR), as determined by an IERC per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). BOR was defined as the best response recorded from the start of the study treatment until the end of treatment. CR was defined as disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
| Arm | Type | Description |
|---|---|---|
| Best Supportive Care | ACTIVE_COMPARATOR | - |
| Botensilimab + Balstilimab and Best Supportive Care | EXPERIMENTAL | - |
| Experimental arm | EXPERIMENTAL | Patients treated with Botensilimab + Balstilimab |
| Standard arm | ACTIVE_COMPARATOR | o FOLFOX\*, IV, Q2W + Nivolumab 240mg, IV, Q2. \*FOLFOX = oxaliplatin 85 mg/m2 , leucovorin 400 mg/m2 , and fluorouracil 400 mg/m2 administered IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours daily or per local standard on Days 1 and 2 of each treatment cycle, every 2 weeks. Premedication is not usually required in the first cycle. For subsequent cycles, adequate premedication may be administrated per local standard. OR * XELOX\*, IV, Q3W + Nivolumab (360 mg, IV, Q3W). XELOX = Oxaliplatin 130mg/m² IV on Day 1 of each treatment cycle + capecitabine 1000mg/m² orally twice daily on Days 1 to 14 of each treatment cycle, every 3 weeks * Treatment is recommended until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression. |
| Blood-brain barrier opening with concomitant BAL, BOT, DOX | EXPERIMENTAL | Patients will undergo implantation of Sonocloud-9 after completion of radiotherapy. Within 21 days after implant, ultrasound-based BBB opening with concomitant administration of DOX (30 mg) + BAL (450 mg) every 3 weeks, and BOT (dose 1mg/kg) every 6 weeks will be initiated. |
| Balstilimab | EXPERIMENTAL | 300 mg IV every 3 weeks for a maximum of 24 months |
| Part 1: Stage 1, Safety Lead-In | EXPERIMENTAL | The safety lead-in will enroll 6 participants. Balstilimab 300mg flat q3 weeks up to 2 years; Zalifrelimab 1mg/kg q6 weeks x 4; Doxorubicin 75mg/m2 q3 weeks x 2, starts at C2 The participants will complete a dose-limiting toxiciy (DLT) observation period of 9 weeks. |
| Part 1: Stage 2, Expansion | EXPERIMENTAL | Balstilimab 300mg flat q3 weeks up to 2 years; Zalifrelimab 1mg/kg q6 weeks up to 2 years; Doxorubicin 75mg/m2 q3 weeks x 6 |
| Part 2: Stage 2, Dose 1 | EXPERIMENTAL | Doxorubicin 60mg/m2 q3 weeks x 6 doses Botensilimab 75mg q6 weeks up to two years |
| Stage 2, Dose 2 | EXPERIMENTAL | Doxorubicin 75mg/m2 q3 weeks x 6 doses Botensilimab 75mg q6 weeks up to two years |
| Stage 2, Dose 3 Combination of Doxorubicin with Botensilimab and Balstilimab | EXPERIMENTAL | Doxorubicin 75mg/m2 q3 weeks x 6 doses Botensilimab 75mg flat q6 weeks up to 2 years Balstilimab 450mg q3 weeks up to 2 years |
| Treatment (ivermectin, balstilimab) | EXPERIMENTAL | Patients will receive balstilimab 450 mg or pembrolizumab 200 mg, IV, on Day 1 of each 3 week cycle and ivermectin at the assigned dose (see Section 5.1, Table 5.1.2), PO, Days 1-3, 8-10, 15-17 of each cycle (Days 1-3 of each week) until disease progression, intolerable toxicities, withdrawal of consent, or up to 35 treatments or 2 years of balstilimab or pembrolizumab, whichever comes first |
| 30 mg (Dose Level 1) | EXPERIMENTAL | 14-day cycles of combined AGEN2034 3 mg/Kg iv on D1 of each cycle, and oral CR6086 30 mg twice a day for 14 days |
| 90 mg (Dose Level 2) | EXPERIMENTAL | 14-day cycles of combined AGEN2034 3 mg/Kg iv on D1 of each cycle, and oral CR6086 90 mg twice a day for 14 days |
| 180 mg (Dose Level 3) | EXPERIMENTAL | 14-day cycles of combined AGEN2034 3 mg/Kg iv on D1 of each cycle, and oral CR6086 180 mg twice a day for 14 days |
| other mGI cancers | EXPERIMENTAL | 14-day cycles of combined AGEN2034 3 mg/Kg iv on D1 of each cycle, and oral CR6086 90 mg twice a day for 14 days |
| Expansion in MSS/pMMR mCRC patients | EXPERIMENTAL | 14-day cycles of combined AGEN2034 3 mg/Kg iv on D1 of each cycle, and oral CR6086 90 mg twice a day for 14 days |
| Monotherapy | EXPERIMENTAL | Dose of 3 mg/kg intravenous (IV) every 2 weeks for up to 24 months. |
| Name | Type | Description |
|---|---|---|
| Best Supportive Care | OTHER | Measures designed to provide palliation of symptoms and improve quality of life as much as possible |
| Balstilimab | DRUG | 450mg IV every 3 weeks |
| Botensilimab | DRUG | 75mg IV every 6 weeks x 4 doses |
| Folfox Protocol | DRUG | oxaliplatin 85 mg/m2 , leucovorin 400 mg/m2 , and fluorouracil 400 mg/m2 administered IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours daily or per local standard on Days 1 and 2 of each treatment cycle, every 2 weeks.Treatment is recommended until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression. |
| XELOX | DRUG | Oxaliplatin 130mg/m² IV on Day 1 of each treatment cycle + capecitabine 1000mg/m² orally twice daily on Days 1 to 14 of each treatment cycle, every 3 weeks. Treatment is recommended until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression. |
| Nivolumab | DRUG | 240mg, IV, Q2. Treatment is recommended until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression. |
| Liposomal Doxorubicin | DRUG | Liposomal Doxorubicin 30 mg IV over 30 minutes every 3 weeks |
| Sonocloud-9 (SC-9) | DEVICE | Device activation of 9 ultrasound emitters during IV injection of microbubbles every 3 weeks |
| Zalifrelimab | DRUG | Zalifrelimab (AGEN1884) is a fully human monoclonal immunoglobulin G1 κ subclass (IgG1κ) antibody that specifically recognizes cytotoxic T lymphocyte-associated protein 4 (CTLA-4, also known as CD152). Zalifrelimab (AGEN1884) is being developed as a monotherapy for cancer indications with potential for future development in combination with other immunotherapies. |
| Doxorubicin | DRUG | Doxorubicin is the standard of care first-line therapy for most subtypes of metastatic soft tissue sarcomas. Doxorubicin monotherapy administered at 75 mg/m2 has resulted in objective response rate of 14%, and median progression-free survival of 4.6 months, and another study reported progression-free survival at 6 months of 46.3%, with a median PFS of 5.8 months, and best objective response rate of 19%. |
| Ivermectin | DRUG | Ivermectin at the assigned dose administered PO on Days 1-3, 8-10, 15-17 of each 21 day cycle (Days1-3 of each week). |
| Balstilmab | DRUG | Balstilimab 300 mg administered intravenously on Day 1 of each 21 day cycle. |
| Pembrolizumab | DRUG | Pembrolizumab 200 mg IV on Day 1 of each 21 day cycle |
| CR6086 | DRUG | oral CR6086, twice a day for 14 days |
| AGEN2034 | BIOLOGICAL | AGEN2034 3 mg/Kg iv on D1 of each 14- day cycle |
Inclusion Criteria: * Must have histologically confirmed colorectal adenocarcinoma that is not deficient mismatch repair (dMMR) or microsatellite instability-high (MSI-H). * Received and failed all prior available therapies, such that the standard of care for the patient would be best supportive ca...
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Balstilimab is an investigational monoclonal antibody being developed by Agenus Inc. (ticker AGEN) for the treatment of several cancer types. It is being studied in solid tumors and blood cancers, including colorectal cancer, gastric cancer, lymphoma, newly diagnosed glioblastoma, metastatic soft tissue sarcoma, and anatomic stage IV breast cancer.
Balstilimab targets PDCD1, also known as PD-1. It acts as an antagonist at this receptor, meaning it blocks PD-1 signaling. PD-1 is an immune checkpoint that normally restrains T cell activity, so antagonizing it is intended to support immune responses against tumor cells. Balstilimab is a monoclonal antibody.
Balstilimab is being developed by Agenus Inc., which trades under the ticker AGEN. Agenus is the company behind the program, and the drug is being evaluated both as a single agent and in combination with other immune therapies in its clinical trials.
Balstilimab is investigational and remains in clinical development. Its registered trials span Phase 2 and Phase 3 studies, including a Phase 3 study in chemo-refractory, unresectable colorectal adenocarcinoma and a Phase 2 study in relapsed or refractory lymphomas. It is not described as an approved therapy.
Balstilimab appears in several registered studies. NCT07152821 is a Phase 3 trial in chemo-refractory, unresectable colorectal adenocarcinoma in Canada and France. NCT06346197 is a Phase 3 trial in MSI/dMMR esogastric adenocarcinomas in France. NCT05891821 is a Phase 2 lymphoma study in Armenia, and NCT05864534 is a Phase 2a glioblastoma study in the United States.
Yes, Balstilmab is an alternative spelling of Balstilimab. Both names refer to the same investigational monoclonal antibody developed by Agenus Inc. that targets PDCD1. Readers searching for either spelling are looking at the same drug program and the same set of clinical trials.