Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Phase 1 study to determine the safety and tolerability of QTX3034 as a single agent or in combination with cetuximab.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1a: QTX3034 monotherapy dose-escalation | Experimental | QTX3034 will be administered at protocol defined dose based on cohort assignment |
|
| Part 1b: QTX3034 combination with cetuximab dose-escalation | Experimental | QTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment |
|
| Part 2: QTX3034 monotherapy dose-expansion | Experimental | QTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment |
|
| Part 3: QTX3034 combination with cetuximab dose-expansion | Experimental | QTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QTX3034 | Drug | QTX3034 will be administered at protocol defined dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of participants with Treatment-emergent Adverse Events (TEAEs) | Defined 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 |
| Measure | Description | Time Frame |
|---|---|---|
| QTX3034 pharmacokinetic parameters in plasma | Plasma concentration data for QTX3034 will be used to evaluate PK parameters such as maximum concentration (Cmax), minimum concentration (Cmin), time to attain Cmax (Tmax), area under the concentration-time curve (AUC), elimination half-life (t1⁄2). | up to 2 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined Inclusion/Exclusion Criteria may apply
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Quanta Therapeutics Clinical Trials | Contact | 415-599-3892 | clinicaltrials@quantatx.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Hematology/Oncology | Recruiting | Los Angeles | California | 90095 | United States |
Not provided
| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cetuximab | Combination Product | Cetuximab will be administered at protocol defined dose. |
|
| 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 |
| Sarah Cannon Research Institute (SCRI) | Recruiting | Denver | Colorado | 80218 | United States |
|
| Yale Cancer Center | Recruiting | New Haven | Connecticut | 06511 | United States |
|
| Florida Cancer Specialists | Recruiting | Sarasota | Florida | 34232 | United States |
|
| Moffitt Cancer Center | Recruiting | Tampa | Florida | 33612 | United States |
|
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
|
| Montefiore Medical Center | Recruiting | The Bronx | New York | 10461 | United States |
|
| Duke University | Recruiting | Durham | North Carolina | 27710 | United States |
|
| Stephenson Cancer Center | Recruiting | Oklahoma City | Oklahoma | 73104 | United States |
|
| SCRI- Nashville | Recruiting | Nashville | Tennessee | 37203 | United States |
|
| MD Anderson | Recruiting | Houston | Texas | 77030 | United States |
|
| START San Antonio, LLC | Recruiting | San Antonio | Texas | 78229 | United States |
|
| University of Utah, Huntsman Cancer Center | Recruiting | Salt Lake City | Utah | 84112 | United States |
|
| NEXT Oncology Virginia | Recruiting | Fairfax | Virginia | 22031 | United States |
|
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |