Neoplasms

All Conditions

Digestive System Diseases

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Colorectal Neoplasms

Melanoma

Carcinoma, Non-Small-Cell Lung

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Herbal and Botanical

All Drugs and Chemicals

Amino Acids

Cola

Asparagine

Multiple ascending doses of ASN003 will be administered to determine the maximum tolerated dose (MTD).

ASN003 administered at the MTD in subjects with BRAF v600 mutated metastatic melanoma

ASN003 administered at the MTD in subjects with BRAFv600 mutated metastatic colorectal or non-small cell lung cancer.

ASN003 administered at the MTD in subjects who have mutations in PI3 kinase or loss of PTEN.

ASN003 ascending doses

The highest safe and well tolerated dose selected from the doses tested in Part A of the study.

ASN003 MTD

Asana BioSciences

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)

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.

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

Tumor biopsy samples will be tested to look for changes

The MTD will be determined by evaluating the number of subjects with treatment related dose limiting toxicity. This is the primary endpoint of Part A

Evaluation of the overall disease status using the RECIST 1.1 terms of complete response, partial response, stable disease, and progressive disease. This is the primary endpoint for Part B

A plot of the concentration of ASN003 in blood plasma over time.

The time required for ASN003 to lose half of its pharmacologic activity.

Pre-dose and post-dose pharmacodynamic biomarkers in plasma and tumor biopsy will be compared to assess signs of pharmacodynamic activity

Change from baseline in the sum of the longest dimension in centimeters of each measurable lesion, the presence/absence of lesions that cannot be measured in centimeters, or the presence of new lesions.

Number of subjects that have resolution of non-measurable tumor lesions.

Spots Global Cancer Trial Database for asn003 ascending doses