NCT03415126

A Study of ASN007 in Patients With Advanced Solid Tumors

A Phase 1, Open-Label, Dose-Finding Study Of ASN007 In Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Asana BioSciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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. Group 6: Patients with metastatic MEK1, BRAF V600E, non-BRAF V600E solid tumors or BRAF fusions without prior treatment with BRAF, MEK, ERK inhibitors

Conditions

• 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

Type	Name	Description
DRUG	ASN007: ascending doses	Oral drug for the treatment of advanced solid tumors
DRUG	ASN007 RD	Oral drug for the treatment of advanced solid tumors

Timeline

• Start date: 2018-01-19
• Primary completion: 2020-06-30
• Completion: 2020-06-30
• First posted: 2018-01-30
• Last updated: 2020-07-09

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study