Cancer Clinical Trial
Official title:
A Phase 1, Open-Label, Dose-Finding Study Of ASN007 In Patients With Advanced Solid Tumors
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
;
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