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
The primary purpose of this study is to evaluate the safety, pharmacokinetics, and anti-tumor activity of TLN-372 as a single agent and in combination with other anti-tumor agents, in patients with advanced KRAS mutant solid tumors
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Agent | Experimental |
| |
| Combination Treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TLN-372 | Drug | Specified dose on specified days |
| |
| TLN-372 in combination with cetuximab |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients experiencing adverse events (AEs) that meet protocol-defined dose-limiting toxicity (DLT) criteria following administration of TLN-372 | Up to 2 years | |
| Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) leading to dose modification and discontinuation. | Up to 2 years | |
| Anti-tumor activity of TLN-372 by evaluating the objective response rate (ORR) according to the RESIST v1.1 | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of TLN-372 | Up to 2 years | |
| Time to peak drug concentration (Tmax) of TLN-372 | Up to 2 years | |
| Minimum observed plasma concentration (Cmin) of TLN-372 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Treeline Clinical Operations | Contact | 857-228-0050 | clinicaloperations@treeline.bio |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35294 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| C582435 | pembrolizumab |
| 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
| Drug |
Specified dose on specified days |
|
| TLN-372 in combination with pembrolizumab | Drug | Specified dose on specified days |
|
| Up to 2 years |
| Area Under the Plasma Concentration-Time Curve (AUC) of TLN-372 | Up to 2 years |
| Anti-tumor activity of TLN-372 by evaluating the duration of response (DOR) as assessed by the time from the date of first objective response to the date of disease progression | Up to 2 years |
| Frequency of dose interruptions, reductions and dose intensity | Up to 2 years |
| Clinically significant ECG QT Interval from baseline in safety laboratory test results, assessed as per NCI CTCAE v5.0 | Up to 2 years |
| Clinically significant laboratory abnormalities from baseline in safety laboratory test results, assessed as per NCI CTCAE v5.0 | Up to 2 years |
| Dana-Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215-5450 | United States |
|
| START Midwest | Recruiting | Grand Rapids | Michigan | 49546 | United States |
|
| Washington University Medical Campus | Recruiting | St Louis | Missouri | 63108 | United States |
|
| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10021-3402 | United States |
|
| Sarah Cannon Research Institute | Recruiting | Nashville | Tennessee | 37203 | United States |
|
| Peter MacCallum Cancer Centre | Recruiting | Melbourne | Victoria | Australia |
|
| Linear Clinical Research | Recruiting | Perth | Western Australia | 6009 | Australia |
|
| Princess Margaret Cancer Centre | Recruiting | Toronto | Ontario | M5G 1X6 | Canada |
|
| Hospital Universitary Vall d'Hebron | Recruiting | Barcelona | 08035 | Spain |
|
| START Madrid_Hospital Universitario HM Sanchinarro_CIOCC | Recruiting | Madrid | 28050 | Spain |
|
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |