Protocol #: 18-228
Status
Recruiting
Description
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.
Condition
Cancer
Malignancy
Neoplasia
Neoplasm
Neoplasm Metastasis
Colon Cancer
Colonic Neoplasms
Colon Cancer Liver Metastasis
Metastatic Cancer
Metastatic Melanoma
Metastatic Colon Cancer
Metastatic Lung Cancer
Non Small Cell Lung Cancer Metastatic
Pancreatic Cancer
Pancreas Cancer
Pancreas Adenocarcinoma
Pancreas Neoplasm
Metastatic Nonsmall Cell Lung Cancer
Metastatic Pancreatic Cancer
Interventions
ASN007: ascending doses
ASN007 RD
Phase
Phase 1
Study Type
Interventional
Further Study Details
Primary Outcome:
Part A: Determine the maximum tolerated dose (MTD) of ASN007
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.
Secondary Outcome:
Calculate the pharmacokinetic area under the plasma concentration (AUC) of ASN007
Calculate the maximum plasma concentration (Cmax) at steady state.
Calculate the terminal elimination rate (T 1/2).
Estimated Enrollment
110
Study Start Date
January 19, 2018
Eligibility
Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Health Volunteers: No
Criteria
Asana BioSciences
Information Provided By
Asana BioSciences
Official Title
A Phase 1, Open-Label, Dose-Finding Study Of ASN007 In Patients With Advanced Solid Tumors
Clinicaltrials.gov Identifier
NCT03415126

 

 

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.

Back to Top