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This is a multicenter, open label, Phase 1 dose escalation study of TJ004309 in combination with standard dose atezolizumab in patients with advanced or metastatic cancer in patients who are refractory to or intolerant to all available therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TJ004309 plus Atezolizumab | Experimental | TJ004309 will be dose escalated in a 3+3 design in combination with atezolizumab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TJ004309 | Drug | Antibody to CD73 |
| |
| Atezolizumab |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerate Dose of TJ004309 plus Atezolizumab | Evaluate safety and tolerability and determine a recommended Phase 2 dose of TJ004309 when combined with standard dose atezolizumab in patients with advanced or metastatic cancer. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 and coded using MedDRA 14.1. | Approximately 2-8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Determine Phase 2 dose to TJ004309 as a single agent | Determine the Phase 2 dose of TJ004309 as a single agent | Approximately 2-8 months |
| Trough TJ004309 concentrations | Trough (pre-dose and post-dose) serum TJ004309 concentrations will be measured when given as a single agent and with atezolizumab |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Theuer, MD, PhD | Medical Monitor | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| HonorHealth Research Institute |
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| Label | URL |
|---|---|
| TRACON Pharmaceuticals | View source |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 16, 2022 |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000594389 | atezolizumab |
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| Drug |
Humanized monoclonal antibody to PD-L1 |
|
| Approximately 2-8 months |
| Trough atezolizumab concentrations | Trough (pre-dose and post-dose) serum atezolizumab concentrations will be measured when given with TJ004309 | Approximately 2-8 months |
| Determine the Rate of TJ004309 Immunogenicity | The number of patients who develop immunogenicity to TJ004309 (anti-product antibody development) will be determined. | Approximately 2-8 months |
| Determine the Rate of Atezolizumab Immunogenicity | The number of patients who develop immunogenicity to atezolizumab (anti-product antibody development) will be determined. | Approximately 2-8 months |
| Assessment of antitumor activity | Antitumor activity will be assessed by the response rate by iRECIST and RECIST 1.1 | Approximately 2-8 months |
| Scottsdale |
| Arizona |
| 85258 |
| United States |
| City of Hope | Duarte | California | 91010 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77230 | United States |