ASTX029 for Solid Tumors
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests ASTX029, a new drug, to determine its safety and effectiveness for individuals with advanced solid tumors, such as certain lung cancers and melanoma, who lack other treatment options. The trial will explore various doses to identify the optimal one and examine its effects on specific gene mutations. It suits those with difficult-to-treat cancers who have exhausted other treatments. As a Phase 1 trial, this research aims to understand how the treatment works in people, providing participants the opportunity to be among the first to receive this new drug.
Will I have to stop taking my current medications?
The trial requires that you stop certain prior anticancer treatments before starting the study drug. Specifically, you must stop cytotoxic chemotherapy or radiotherapy 3 weeks before, monoclonal antibodies 4 weeks before, and molecularly targeted or investigational drugs 4 weeks before or 5 half-lives, whichever is shorter. Other medications are not specified, so it's best to discuss with the trial team.
Is there any evidence suggesting that ASTX029 is likely to be safe for humans?
Research shows that ASTX029 is undergoing its first human trials to assess safety. This treatment targets individuals with advanced solid tumors who lack other treatment options. In these early studies, researchers aim to identify a safe, tolerable dose and understand how the treatment functions in the body.
Because ASTX029 is in the early testing phase, information on tolerance is limited. These studies are essential to determine if the treatment causes any side effects. Participants receive varying doses to identify the safest option, helping to ensure that potential risks are understood and managed.
It is important to note that ASTX029 has not been tested in humans before these trials. Therefore, all safety information derives from these new studies. Participants should be aware that they are part of the initial safety testing.12345Why do researchers think this study treatment might be promising for solid tumors?
Researchers are excited about ASTX029 because it targets the MAPK signaling pathway, which is often altered in various cancers, like BRAF and RAS mutations. Unlike traditional chemotherapy, which non-specifically attacks rapidly dividing cells, ASTX029 specifically inhibits key proteins in this pathway, potentially leading to more precise cancer targeting with fewer side effects. This strategic approach could offer a groundbreaking alternative for patients with tumors that are resistant to existing treatments, making it a promising development in cancer therapy.
What evidence suggests that ASTX029 might be an effective treatment for solid tumors?
Research has shown that ASTX029 is a promising treatment for some advanced solid tumors. This drug blocks ERK1/2, proteins that aid cancer cell growth and survival, which are often overactive in cancer cells. Early studies indicate that ASTX029 effectively controls these proteins, potentially slowing or stopping tumor growth. In this trial, researchers are studying participants with changes in the RAS or BRAF genes in specific cohorts. Initial findings suggest that these patients have responded well. Although more information is needed, these early results are encouraging for those with these specific gene changes in their cancers.12567
Who Is on the Research Team?
Kim-Hien Dao, DO, PhD
Principal Investigator
Astex Pharmaceuticals, Inc.
Are You a Good Fit for This Trial?
Adults with advanced solid tumors that can't be removed or have spread, and who've tried all other treatments without success. They must be over 18, not pregnant or breastfeeding, willing to use contraception, and able to follow study procedures. Their cancer should have specific gene changes in the MAPK pathway and measurable by certain medical criteria.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1 Treatment
Dose escalation and expansion to determine the maximum tolerated dose and recommended Phase 2 dose of ASTX029
Phase 2 Treatment
Assessment of preliminary clinical activity in tumors with gene aberrations in the MAPK signal pathway
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ASTX029
Find a Clinic Near You
Who Is Running the Clinical Trial?
Taiho Oncology, Inc.
Lead Sponsor
Tim Whitten
Taiho Oncology, Inc.
Chief Executive Officer since 2018
MBA and Pharmacy degree
Harold Keer
Taiho Oncology, Inc.
Chief Medical Officer
MD, PhD
Astex Pharmaceuticals, Inc.
Lead Sponsor
Dr. Harren Jhoti
Astex Pharmaceuticals, Inc.
Chief Executive Officer since 2007
PhD in Biochemistry from Birkbeck College, London
Dr. Harold N. Keer
Astex Pharmaceuticals, Inc.
Chief Medical Officer since 2020
MD