63 Participants Needed

ANS014004 for Cancer

Recruiting at 8 trial locations
AC
Overseen ByAvistone Clinical Study Information Center
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Avistone Biotechnology Co., Ltd.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called ANS014004 for individuals with locally advanced or metastatic solid tumors. The main goal is to determine the safety of ANS014004 and assess its effectiveness against tumors. The trial will also identify the optimal dose for future studies. Participants must have a specific alteration in the MET gene associated with their cancer type. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that ANS014004 is likely to be safe for humans?

Research shows that ANS014004 is currently undergoing safety testing in people. As this is its first trial in humans, detailed safety information from earlier human trials is not yet available. However, this treatment is in a Phase 1 trial, where researchers focus on assessing how well people tolerate the treatment and identifying any side effects.

ANS014004 is under close observation to determine its safety for people. Participants in this study help researchers understand how the treatment works in the body and its potential effects. Although specific human safety data is not yet available, the progression to human trials suggests that earlier lab and possibly animal tests showed promising results.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for cancer, which often include chemotherapy, radiation, or targeted therapies, ANS014004 is unique because it focuses on a novel mechanism of action. This experimental drug is designed to not only be safe and well-tolerated but also to precisely target specific pathways in solid tumors. Researchers are excited about ANS014004 because it has the potential to offer a more tailored approach to cancer treatment, which could lead to better outcomes with fewer side effects.

What evidence suggests that ANS014004 might be an effective treatment for cancer?

Research has shown that ANS014004 could be a promising treatment for certain types of cancer. This drug blocks a specific protein that aids cancer cell growth and spread. In early lab studies, ANS014004 stopped tumors from growing. Although these initial results are encouraging, the treatment is still under investigation in this trial to ensure its safety and effectiveness for people. Initial signs suggest it might help control cancer by targeting proteins that drive cancer growth.24678

Who Is on the Research Team?

MD

Medical Director Clinical Science

Principal Investigator

Beijing Avistone Biotechnology Co., Ltd.

Are You a Good Fit for This Trial?

This trial is for people with advanced or widespread solid tumors. It's the first time humans will try ANS014004. Participants should have a tumor that has either grown beyond its original location or spread to other parts of the body.

Inclusion Criteria

Life expectancy ≥ 12 weeks
My organs and bone marrow are working well.
I am fully active or can carry out light work.
See 2 more

Exclusion Criteria

I have cancer that has spread to my brain or spinal cord.
I have serious heart or brain blood vessel diseases.
I have active or untreated brain metastases.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ANS014004 to determine safety, tolerability, and preliminary anti-tumor activity

Approximately 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 days post last dose

What Are the Treatments Tested in This Trial?

Interventions

  • ANS014004
Trial Overview The study is testing ANS014004, which is a new potential treatment for solid tumors. This early-phase trial will check how safe it is, how well patients can handle it, what happens to it in the body (pharmacokinetics), and if it might shrink tumors.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: ANS014004 MonotherapyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Avistone Biotechnology Co., Ltd.

Lead Sponsor

Trials
10
Recruited
1,400+

Citations

A Study to Evaluate ANS014004 in Subjects With Locally ...Brief Summary: This is a Phase I, first-in-human, open-label, multi-center study designed to explore the safety, tolerability, PK, ...
Avistone's ANS014004, a Novel c-Met Inhibitor, Advances in ...Avistone Biotechnology's ANS014004, a type II c-Met inhibitor, has been cleared for Phase I trial enrollment in Canada, expanding its clinical evaluation.
Avistone Announces Preclinical Results for ANS014004, a ...Avistone Biotechnology Co., Ltd announced results from its China and US IND enabling nonclinical studies for ANS014004, a novel small-molecule type II c-Met ...
ANS-014004 - Drug Targets, Indications, Patents... Efficacy of ANS014004 Monotherapy in Subjects With Locally Advanced or Metastatic Solid Tumors ... Clinical Results associated with ANS-014004. Login to ...
ANS014004 / Avistone BiotechANS014004, a new generation of targeted drug, has finally started clinical trials and is now recruiting patients with solid tumors [Google translation] ...
NCT06307795 | A Study to Investigate ANS014004 in ...Part 2 aims to determine the safety, tolerability and evaluate anti-tumor activity of ANS014004 as monotherapy in select solid tumors. Intervention/Treatment ...
ANS014004-I-US-01 - A Phase 1 study evaluating the ...A Phase 1 study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of ANS014004 as a single agent in participants with locally ...
Trial | NCT06307795Part 2 aims to determine the safety, tolerability and evaluate anti-tumor activity of ANS014004 as monotherapy in select solid tumors. DRUG ANS014004.
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