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Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

  • Adenocarcinoma
  • Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Colon Cancer
  • Colon Cancer Liver Metastasis
  • Colonic Neoplasms
  • Lung Neoplasms
  • Malignancy
  • Metastatic Cancer
  • Metastatic Colon Cancer
  • Metastatic Lung Cancer
  • Metastatic Melanoma
  • Metastatic Nonsmall Cell Lung Cancer
  • Metastatic Pancreatic Cancer
  • Neoplasia
  • Neoplasm
  • Neoplasm Metastasis
  • Neoplasms
  • Non Small Cell Lung Cancer Metastatic
  • Pancreas Adenocarcinoma
  • Pancreas Cancer
  • Pancreas Neoplasm
  • Pancreatic Cancer
  • Pancreatic Neoplasms

NCT number NCT03415126
Study type Interventional
Source Asana BioSciences
Contact Study Manager, PhD
Phone 908-698-0988
Status Recruiting
Phase Phase 1
Start date January 19, 2018
Completion date May 2020

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