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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