Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Balstilimab · 5 trials · 12 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.
| 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 |
| 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%. |
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 oncology therapy being studied for gastric cancer, colorectal cancer, lymphoma, metastatic soft tissue sarcoma, and newly diagnosed glioblastoma. It is in Phase 3 clinical development for certain indications. The drug is being evaluated in clinical trials for these cancer types.
Balstilimab targets PDCD1, also known as programmed cell death protein 1, and acts as an antagonist. By blocking PDCD1, it is designed to modulate immune responses in cancer treatment. This mechanism is being investigated across multiple oncology indications.
Balstilimab is being developed by Agenus Inc., a biopharmaceutical company traded on NASDAQ under the ticker AGEN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various cancer types.
Balstilimab is in Phase 3 clinical development for gastric cancer and colorectal cancer. It is also being studied in Phase 2 trials for lymphoma and newly diagnosed glioblastoma. The drug remains investigational and has not been approved by regulatory authorities.
Balstilimab is being evaluated in several clinical trials, including NCT07152821, a Phase 3 study in colorectal cancer with 834 participants, and NCT06346197, a Phase 3 trial in gastric cancer. Phase 2 trials include NCT05891821 for lymphoma and NCT05864534 for glioblastoma.
No, Balstilimab and botensilimab are different drugs. Balstilimab targets PDCD1, while botensilimab is a separate agent. They are being studied in combination, such as in the Phase 3 trial NCT07152821 for colorectal cancer, but they are distinct investigational therapies.