ANS03 for Cancer

Recruiting at 4 trial locations

Overseen By Avistone Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Avistone Biotechnology Co., Ltd.

Disqualifiers: Active infection, CNS metastases, cardiovascular diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately 2 years

96 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ANS03 to determine its safety and effectiveness for people with advanced solid tumors, a type of cancer that forms solid masses in the body. The researchers aim to understand how the drug behaves in the body and whether it can help shrink tumors. The trial seeks participants with a specific genetic change called ROS1 or NTRK alteration who meet certain health criteria. Participants must have measurable cancer and be in generally good health otherwise. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

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 ANS03 is likely to be safe for humans?

Research shows that ANS03 remains in the early testing stages, meaning limited information exists about its effects on people. As a new treatment tested in humans for the first time, the main goal is to assess its safety and tolerability.

In studies so far, ANS03 has been examined for its ability to target specific cancer cell changes. However, as a Phase 1 trial, the primary aim is to determine the right dose and identify any side effects. While specific information on side effects is not yet available, treatments at this stage often begin with small doses to ensure safety.

Prospective trial participants should know that researchers exercise great caution. They aim to ensure ANS03's safety before proceeding to further testing. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard cancer treatments like chemotherapy or radiation, ANS03 acts as a monotherapy with a potentially unique mechanism. Researchers are excited because ANS03 targets cancer cells in a way that may reduce damage to healthy cells, minimizing side effects compared to traditional therapies. This innovative approach could lead to more effective and safer cancer treatment options, making it a promising candidate in the fight against cancer.

What evidence suggests that ANS03 might be an effective treatment for cancer?

Research has shown that ANS03, the treatment under study in this trial, is a promising new option for advanced solid tumors. It blocks certain proteins, called ROS1 and NTRK, which can slow or stop cancer growth. Early studies found that ANS03 remains effective even when other treatments fail. Patients take ANS03 as a pill, making it easy to use. Although human trial data is limited, early lab results are encouraging. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for individuals with advanced solid tumors that have spread or cannot be removed by surgery. Participants should not have had prior treatment with ANS03 and must be in a condition to follow the study procedures.

Inclusion Criteria

Life expectancy ≥ 12 weeks

Measurable disease per RECIST v1.1

I am able to get out of my bed or chair and move around.

Exclusion Criteria

I have cancer that has spread to my brain or spinal cord.

I have active or untreated brain metastases.

I have serious heart or brain blood vessel diseases.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ANS03 as monotherapy to evaluate safety, tolerability, and preliminary efficacy

Approximately 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ANS03

Trial Overview The trial is testing ANS03, a new potential cancer treatment. It's an early-stage (Phase I) study assessing safety, how well it's tolerated, its preliminary effectiveness against tumors, and how the body processes it.

How Is the Trial Designed?

Group I: ANS03 monotherapy Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Avistone Biotechnology Co., Ltd.

Lead Sponsor

Trials

10

Recruited

1,400+

Published Research Related to This Trial

Anlotinib significantly improved overall survival (OS) and progression-free survival (PFS) in patients with non-small cell lung cancer (NSCLC) regardless of their EGFR mutation status, with OS of 10.7 months for EGFR-positive patients and 8.9 months for EGFR-negative patients compared to placebo.

The efficacy of anlotinib was demonstrated through substantial improvements in PFS as well, with 5.6 months for EGFR-positive and 5.4 months for EGFR-negative patients, indicating that anlotinib is a viable third-line treatment option for NSCLC patients irrespective of their genetic profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of anlotinib as third-line treatment for non-small cell lung cancer by EGFR mutation status: a subgroup analysis of the ALTER0303 randomized phase 3 study. Zhao, Y., Wang, Q., Zhang, L., et al.[2022]

Citations

1. aacrjournals.org aacrjournals.org/cancerres/article/85/8_Supplement_1/828/755303/Abstract-828-ANS03-a-novel-orally-bioavailable

ANS03, a novel, orally bioavailable small-molecule type II ... A novel, orally bioavailable small-molecule type II ROS1/NTRK inhibitor, effectively overcomes clinically relevant ROS1/NTRK resistance mutations and exhibits ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06716138

A Study to Investigate ANS03 in Participants With Locally ... Study Details | NCT06716138 | A Study to Investigate ANS03 in Participants With Locally Advanced or Metastatic Solid Tumors | ClinicalTrials.gov.

3. mskcc.org mskcc.org/cancer-care/clinical-trials/25-099

A Phase 1 Study of ANS03 in People With Advanced Solid ... By blocking these proteins, ANS03 may help slow or stop the growth of your cancer. It is taken orally (by mouth).

4. withpower.com withpower.com/trial/phase-1-neoplasms-2-2025-a2310

ANS03 for Cancer · Recruiting Participants for Phase ... Anlotinib significantly improved overall survival (OS) and progression-free survival (PFS) in patients with non-small cell lung cancer (NSCLC) regardless of ...

5. en.avistonebio.com en.avistonebio.com/news_details/112.html

NEWS - Avistone Biotechnology Non-clinical studies of ANS03 showed it was a potent, orally bioavailable Type II ROS1/NTRK inhibitor with remarkable activity against various pathogenetic ROS ...

6. synapse.patsnap.com synapse.patsnap.com/drug/0a661e96332c4d0a80105cd801f78e79

ANS-03 - Drug Targets, Indications, Patents A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ANS03 as a Single Agent in Participants ...