Clinical Trials Logo
NCT number NCT03415126
Study type Interventional
Source Asana BioSciences
Contact Study Manager
Phone 908-698-4973
Status Recruiting
Phase Phase 1
Start date January 19, 2018
Completion date May 2020

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

See also
  Status Clinical Trial Phase
Completed NCT01285037 - A Study of LY2801653 in Advanced Cancer Phase 1
Active, not recruiting NCT00680992 - Study of Denosumab in Subjects With Giant Cell Tumor of Bone Phase 2
Completed NCT00340522 - Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development N/A
Recruiting NCT03167372 - Pilot N-of-1 Light Therapy Study N/A
Recruiting NCT03109041 - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source Phase 1
Terminated NCT01441115 - ECI301 and Radiation for Advanced or Metastatic Cancer Phase 1
Completed NCT01077414 - Phenomenological Study of Psycho-Socio-Spiritual Healing in the Context of Chronic or Life-Threatening Illness N/A
Enrolling by invitation NCT02565004 - Clinical and Laboratory Analysis of Familial Cancer N/A
Completed NCT01340846 - A Pharmacokinetics Study of the Effects of GSK2118436 on Warfarin, the Effects of Ketoconazole and Gemfibrozil on GSK2118436, and the Effects of Repeat Doses of GSK2118436 in Subjects With BRAF Mutant Solid Tumors Phase 1
Active, not recruiting NCT02502396 - Rivaroxaban Utilization for Treatment and Prevention of Thromboembolism in Cancer Patients: Experience at a Comprehensive Cancer Center N/A
Recruiting NCT03247309 - TCR-engineered T Cells in NSCLC and HNSCC Patients (ACTengine) Phase 1
Active, not recruiting NCT00587886 - Estrogen, Diet, Genetics and Endometrial Cancer N/A
Active, not recruiting NCT00984035 - Investigation of Cisplatin-Related Kidney Toxicity N/A
Not yet recruiting NCT03257969 - Impact of the DROP Program on the DRP (Drug Related Problems) Related to Oral Anticancer Drugs in Ambulatory Patients With Risk Factors N/A
Recruiting NCT02839889 - Tolerability, Safety, and Feasibility of Naloxegol in Patients With Cancer and OIC (Opioid Induced Constipation) Phase 4
Recruiting NCT02869802 - Prospectively Defining Metastatic Pancreatic Ductal Adenocarcinoma Subtypes by Comprehensive Genomic Analysis N/A
Recruiting NCT02883699 - Individually Tailored Training Prescriptions in Cancer Patients: The TOP Study N/A
Active, not recruiting NCT02891993 - Pilot Study of a Symptom Monitoring Intervention for Hospitalized Patients With Cancer N/A
Recruiting NCT02765451 - Study Evaluating Intervention in the Development of Clinical Research in Non-Academic Health Institution (ERNU) N/A
Recruiting NCT02550925 - Acceptance and Commitment Therapy (ACT) for Anxious Cancer Survivors N/A