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Also known as Balstilmab
Balstilimab · 6 trials · 14 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)
| 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 |
| 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 |
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 designed to block the PDCD1 target, also known as PD-1, as a checkpoint antagonist. It is currently in clinical development and has not been approved by the FDA.
Balstilimab is being studied in clinical trials for multiple cancer indications, including colorectal cancer, gastric cancer, lymphoma, metastatic soft tissue sarcoma, newly diagnosed glioblastoma, and anatomic stage IV breast cancer. It is an investigational therapy and is not approved for any indication.
Balstilimab targets PDCD1, also known as PD-1. It acts as an antagonist of this receptor, which is an immune checkpoint. By blocking PD-1, balstilimab is intended to enhance T-cell mediated immune responses against tumor cells.
Balstilimab is being developed by Agenus Inc., a biotechnology company that trades under the ticker symbol AGEN. Agenus is the sponsor of the clinical trials evaluating balstilimab in various oncology indications.
Balstilimab is in Phase 1 of clinical development according to the drug's overall development stage. However, it is being evaluated in later-phase trials, including Phase 2 and Phase 3 studies, in combination with other agents. It remains investigational and has not received FDA approval.
Balstilimab is being evaluated in several clinical trials, including NCT07152821, a Phase 3 study in chemo-refractory colorectal cancer; NCT06346197, a Phase 3 study in MSI/dMMR esogastric adenocarcinomas; NCT05891821, a Phase 2 study in relapsed/refractory lymphomas; and NCT05864534, a Phase 2a study in newly diagnosed glioblastoma.
Yes, Balstilimab is also known as Balstilmab. Both names refer to the same investigational monoclonal antibody developed by Agenus Inc. that targets PDCD1.