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Phase 1 study to determine the safety and tolerability of QTX3046 as a single agent or in combination with cetuximab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1a: QTX3046 monotherapy dose escalation | Experimental | QTX3046 will be administered orally at escalating doses as defined in the protocol based on dose level assignment |
|
| Part 1b: QTX3046 dose escalation in combination with cetuximab | Experimental | QTX3046 will be administered orally at escalating doses as defined in the protocol in combination with intravenous cetuximab based on dose level assignment |
|
| Part 2: QTX3046 monotherapy dose expansion | Experimental | QTX3046 will be administered orally at the recommended phase 2 dose (RP2D) based on cohort assignment |
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| Part 3: QTX3046 dose expansion in combination with cetuximab | Experimental | QTX3046 will be administered orally at the recommended phase 2 dose (RP2D) in combination with intravenous cetuximab based on cohort assignment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QTX3046 | Drug | QTX3046 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 QTX3046 | Plasma concentration data for QTX3046 will be used to evaluate the area under the plasma concentration-time curve (AUC) of QTX3046 | up to 2 years |
| Peak plasma concentration of QTX3046 (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 |
|---|---|---|---|---|---|---|
| South Texas Accelerated Research Therapeutics, LLC Midwest | Grand Rapids | Michigan | 49546 | United States | ||
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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 QTX3046 will be used to evaluate peak plasma concentration (Cmax) of QTX3046 |
| 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) | Duration of response (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 |
| Duke Cancer Center |
| Durham |
| North Carolina |
| 27705 |
| 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 |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |