The study is divided into two parts. The first part of the study will test various doses of ASN007 to find out the highest safe dose to test in five specific groups. The second part of the study will test how well ASN007 can control cancer.
Part A is a dose escalation study to determine a safe and tolerable dose of ASN007 for patients with advanced solid tumors. Part A will also describe how the body works on ASN007(pharmacokinetics) and the effects of ASN007 on the body (pharmacodynamics) of ASN007, through blood sampling and optional biopsies.. Part B of the study will enroll patients with particular tumor types and genetic mutations for treatment at the Recommended Phase 2 Dose. Part B will enroll patients in five groups of fifteen patients each: Group 1: Patients with metastatic BRAF mutated melanoma Group 2: Patients with metastatic NRAS and HRAS mutated solid tumors Group 3: Patients with metastatic KRAS mutated colorectal cancer (CRC) Group 4: Patients with metastatic KRAS mutated non-small cell lung cancer (NSCLC) Group 5: Patients with metastatic pancreatic ductal adenocarcinoma (PDAC) Patients with melanoma will be required to have pre-dose and post-dose biopsies. Group 6: Patients with metastatic MEK1, BRAF V600E, non-BRAF V600E solid tumors or BRAF fusions without prior treatment with BRAF, MEK, ERK inhibitors
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Oral drug for the treatment of advanced solid tumors
Oral drug for the treatment of advanced solid tumors
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
MD Anderson Cancer Center
Houston, Texas, United States
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States
NEXT Oncology
San Antonio, Texas, United States
Part A: Determine the maximum tolerated dose (MTD) of ASN007
The MTD will be determined by evaluating the number of subjects with treatment related dose limiting toxicity. This is the primary endpoint of Part A
Time frame: First 21 days
Part B: evaluate the overall response rate (number of Complete Responses + Partial Responses) in subjects receiving ASN007 for the treatment of metastatic melanoma, CRC, NSCLC, or pancreatic cancer.
This is the primary endpoint for Part B.
Time frame: First 6 months
Calculate the pharmacokinetic area under the plasma concentration (AUC) of ASN007
Calculate the amount of ASN007 in the bloodstream
Time frame: First 21 days
Calculate the maximum plasma concentration (Cmax) at steady state.
Calculate the maximum amount of ASN007 in the bloodstream
Time frame: First 21 days
Calculate the terminal elimination rate (T 1/2).
Calculate how fast ASN007 leaves the body
Time frame: First 21 days
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