NCT02961283

Study of ASN003 in Subjects With Advanced Solid Tumors

A Phase 1, Open-label, Dose-finding and Cohort Expansion Study of ASN003 in Subjects With Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (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 ASN003 to find out the highest safe dose to test in three specific groups. The second part of the study will test how well ASN003 can control cancer. Subjects will be enrolled into one of three groups. Group 1: metastatic or recurrent melanoma with documented BRAFV600 mutation (n=20 evaluable patients) Group 2: metastatic colorectal cancer (CRC), or advanced non-small cell lung cancer (NSCLC) with documented BRAFV600 mutation (n=14 evaluable patients) Group 3: advanced solid tumors with documented PI3K pathway alterations (PIK3CA mutation or PTEN loss) (n=14 evaluable patients)

Detailed description

The study will be conducted in two parts. Part A is a dose escalation study to determine a safe and tolerable dose of ASN003 for subjects with advanced solid tumors. Part A will also characterize the pharmacokinetics and pharmacodynamics of ASN003 through blood sampling and optional biopsies.. Part B will only enroll subjects in three groups: Group 1: subjects who have metastatic or recurrent melanoma with the BRAFv600 mutation. Group 2: subjects who have advanced or metastatic non-small cell lung cancer, or colorectal cancer with the BRAFv600 mutation. Group 3: subjects who have advanced or metastatic cancers with phosphatidylinositide 3-kinases (PI3K) mutations, or phosphatase and tensin homolog (PTEN) loss mutation. Subjects will be treated with the highest safe and tolerable dose determined in Part A of the study to determine preliminary efficacy. Subjects may continue to receive ASN003 for up to 1 year in the absence of severe side effects or disease progression.

Conditions

• Neoplasms
• Melanoma
• Colorectal Neoplasm
• Carcinoma, Non-small Cell Lung

Interventions

Type	Name	Description
DRUG	ASN003 ascending doses
DRUG	ASN003 MTD	The highest safe and well tolerated dose selected from the doses tested in Part A of the study.

Timeline

• Start date: 2016-10-01
• Primary completion: 2019-02-01
• Completion: 2019-02-01
• First posted: 2016-11-10
• Last updated: 2023-05-09

Locations

5 sites across 1 country: United States