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.
Name: ASN007: ascending doses
Name: ASN007 RD
Description: 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
Measure: Part A: Determine the maximum tolerated dose (MTD) of ASN007 Time: First 21 daysDescription: This is the primary endpoint for Part B.
Measure: 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. Time: First 6 monthsDescription: Calculate the amount of ASN007 in the bloodstream
Measure: Calculate the pharmacokinetic area under the plasma concentration (AUC) of ASN007 Time: First 21 daysDescription: Calculate the maximum amount of ASN007 in the bloodstream
Measure: Calculate the maximum plasma concentration (Cmax) at steady state. Time: First 21 daysDescription: Calculate how fast ASN007 leaves the body
Measure: Calculate the terminal elimination rate (T 1/2). Time: First 21 daysDescription: Evaluate the effect of ASN007 on biomarkers
Measure: To evaluate the change from baseline in the intensity of phosphorylated ribosomal S6 kinase (RSK) found in tumor biopsies. Time: Through the study, average 6 monthsDescription: Evaluate the effect of ASN007 on biomarkers
Measure: Evaluate the change from baseline in the amount of circulating tumor DNA Time: Every 8 weeks for the first 24 weeks, then every 12 weeks for up to 1 yearAllocation: Non-Randomized
Parallel Assignment
There is one SNP
Group 6: Patients with metastatic MEK1, BRAF V600E, non-BRAF V600E solid tumors or BRAF fusions without prior treatment with BRAF, MEK, ERK inhibitors --- V600E ---
Group 6: Patients with metastatic MEK1, BRAF V600E, non-BRAF V600E solid tumors or BRAF fusions without prior treatment with BRAF, MEK, ERK inhibitors --- V600E --- --- V600E ---