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| ID | Type | Description | Link |
|---|---|---|---|
| C-1400-01 | Other Identifier | Agenus Inc. |
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This study is a multicenter, Phase 1 study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of AGEN1777 as a single agent and when used in combination with a PD-1 inhibitor in participants with advanced, metastatic solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monotherapy with AGEN1777 | Experimental | 3+3 Dose escalation of AGEN1777 will be administered by Intravenous (IV) infusion every 3 weeks (each cycle is 21 days [3 weeks]). |
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| AGEN1777 in combination with a PD-1 inhibitor | Experimental | 3+3 Dose escalation of AGEN1777 in combination with a PD-1 inhibitor will be administered by IV infusion with specified dose on specified days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGEN1777 | Drug | An immunoglobulin gamma (IgG1) antibody |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Dose-Limiting Toxicities (DLT) of AGEN1777 as a Single-Agent and in Combination with a PD-1 inhibitor | Day 1 through Day 21 | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Up to 2 years and 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration at Steady State (Cmax-ss) of Serum AGEN1777 and a PD-1 inhibitor | Day 1 Up to End of Treatment (up to 2 years) | |
| Serum AGEN1777 Anti-Drug Antibody (ADA) Determination | Day 1 of Cycle 1 (Cycle = 21 days) through Day 1 of Cycle 5. Incidence of ADA |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 165 | Grand Rapids | Michigan | 49546 | United States | ||
| START Midwest |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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Dose escalation
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| a PD-1 inhibitor | Drug | Anti-programmed cell death protein 1 (Anti-PD-1) antibody monoclonal antibody |
|
| Serum a PD-1 inhibitor Anti-Drug Antibody (ADA) Determination | Day 1 Up to End of Treatment (up to 2 years) |
| Complete Response (CR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) Based on Investigator's assessment | From Day 1 of Cycle 1 (each cycle is 21 days [3 weeks]) until every 9 weeks (±7 days) for 12 months, and every 12 weeks (±7 days) thereafter up to 2 years or until progressive disease or unacceptable toxicity |
| Partial Response (PR) per RECIST v1.1 Based on Investigator's Assessment | From Day 1 of Cycle 1 (each cycle is 21 days [3 weeks]) until every 9 weeks (±7 days) for 12 months, and every 12 weeks (±7 days) thereafter up to 2 years or until progressive disease or unacceptable toxicity |
| Duration of Response (DOR) per RECIST v1.1 Based on Investigator's Assessment | From Day 1 of Cycle 1 (each cycle is 21 days [3 weeks]) until every 9 weeks (±7 days) for 12 months, and every 12 weeks (±7 days) thereafter up to 2 years or until progressive disease or unacceptable toxicity. |
| Stable Disease (SD) per RECIST v1.1 Based on Investigator's Assessment | From Day 1 of Cycle 1 (each cycle is 21 days [3 weeks]) until every 9 weeks (±7 days) for 12 months, and every 12 weeks (±7 days) thereafter up to 2 years or until progressive disease or unacceptable toxicity. |
| Grand Rapids |
| Michigan |
| 49546 |
| United States |
| Local Institution - 024 | Southfield | Michigan | 48075 | United States |
| Local Institution - 072 | Cincinnati | Ohio | 45267-0558 | United States |
| University of Cincinnati Cancer Center | Cincinnati | Ohio | 45267 | United States |
| Providence Cancer Institute | Portland | Oregon | 97213 | United States |
| Lifespan Cancer Institute | Providence | Rhode Island | 02903 | United States |
| Local Institution - 0001 | Providence | Rhode Island | 02903 | United States |
| Local Institution - 164 | Dallas | Texas | 75230 | United States |
| Mary Crowley Cancer Research | Dallas | Texas | 75251 | United States |
| MD Anderson Cancer Center Thoracic-Head & Neck Med Onc | Houston | Texas | 77030 | United States |