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Study of ASN003 in Subjects With Advanced Solid Tumors

NCT02961283 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-05-09

No results posted yet for this study

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)

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Asana BioSciences

    lead INDUSTRY

Principal Investigators

  • Asana BioSciences · Asana BioSciences, LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2019-02-28
Completion
2019-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02961283 on ClinicalTrials.gov