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Phase 1 study to determine the safety, tolerability, and anti-tumor activity of QTX3544 as a single agent or in combination with cetuximab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1a: QTX3544 monotherapy dose escalation | Experimental | QTX3544 will be administered at protocol defined dose based on cohort assignment |
|
| Part 1b: QTX3544 dose escalation in combination with cetuximab | Experimental | QTX3544 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment |
|
| Part 2: QTX3544 monotherapy dose expansion | Experimental | QTX3544 will be administered at protocol defined dose based on cohort assignment |
|
| Part 3: QTX3544 dose expansion in combination with cetuximab | Experimental | QTX3544 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QTX3544 | Drug | QTX3544 will be administered at protocol defined dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Treatment-emergent Adverse Events (TEAEs) | Define as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug monotherapy and in combination with cetuximab. | up to 2 years |
| Number of participants with Dose Limiting Toxicities (DLTs) | DLTs will be defined as the occurrence of any of the toxicities as described in the protocol. | up to 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve (AUC) of QTX3544 | Plasma concentration data for QTX3544 will be used to evaluate the area under the concentration-time curve (AUC) of QTX3544. | up to 2 years |
| Peak plasma concentration of QTX3544 (Cmax) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined Inclusion/Exclusion Criteria may apply
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sarah Cannon Research Institute | Denver | Colorado | 80218 | United States | ||
| Yale Cancer Center |
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| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Cetuximab | Combination Product | Cetuximab will be administered at protocol defined dose. |
|
Plasma concentration data for QTX3544 will be used to evaluate peak plasma concentration (Cmax) of QTX3544.
| up to 2 years |
| Objective response rate (ORR) | The ORR is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) based on RECIST 1.1. | up to 2 years |
| Duration of response (DoR) | DoR is defined as the time between first evidence of objective response and disease progression (as measured by RECIST 1.1) or death, whichever occurs earlier, in subjects who achieve CR or PR. | up to 2 years |
| New Haven |
| Connecticut |
| 06511 |
| United States |
| Florida Cancer Specialists & Research Institute | Sarasota | Florida | 34232 | United States |
| South Texas Accelerated Research Therapeutics, LLC Midwest | Grand Rapids | Michigan | 49546 | United States |
| Duke Cancer Center | Durham | North Carolina | 27705 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| South Texas Accelerated Research Therapeutics, LLC San Antonio | San Antonio | Texas | 78229 | United States |
| Huntsman Cancer Institute, University of Utah | Salt Lake City | Utah | 84112 | United States |
| South Texas Accelerated Research Therapeutics Mountain Region, LLC | West Valley City | Utah | 84119 | United States |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |