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

Trial Summary

What is the purpose of this trial?

This is a first-in-human Phase I, multi-center, open-label study of ANS03 in patients with advanced solid tumors. The study evaluates the safety, tolerability, preliminary efficay, pharmacokinetics, anti-tumor activity of ANS03 as monotherapy.

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.

What data supports the effectiveness of the drug ANS03 for cancer?

Research on a similar drug, anlotinib, shows it can help people with advanced lung cancer live longer and slow down the disease's progress. Anlotinib also showed benefits in treating soft tissue sarcoma, suggesting that drugs like ANS03 might be effective for cancer treatment. ^{1 2 3 4 5}

How does the drug ANS03 differ from other cancer treatments?

ANS03 targets Annexin A3 (ANXA3), a protein involved in cancer cell growth and resistance to existing chemotherapy drugs. This makes it unique as it may help overcome drug resistance and improve treatment outcomes for cancers like breast, lung, and liver cancer. ^{6 7 8 9 10}

Eligibility Criteria

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

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

Measurable disease per RECIST v1.1

Life expectancy ≥ 12 weeks

Exclusion Criteria

I have active or untreated brain metastases.

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

I have serious heart or brain blood vessel diseases.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. China 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The real-world clinical outcomes and treatment patterns of patients with unresectable locally advanced or metastatic soft tissue sarcoma treated with anlotinib in the post-ALTER0203 trial era. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

The role of plasma exosomal lnc-SNAPC5-3:4 in monitoring the efficacy of anlotinib in the treatment of advanced non-small cell lung cancer. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Anlotinib in Advanced Non-Small Cell Lung Cancer: A Real-World Study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Effect of anlotinib as a third- or further-line therapy in advanced non-small cell lung cancer patients with different histologic types: Subgroup analysis in the ALTER0303 trial. [2021]

6. Greece pubmed.ncbi.nlm.nih.gov

Annexin A3 and cancer. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Annexin A3, a Calcium-Dependent Phospholipid-Binding Protein: Implication in Cancer. [2021]

8. Cyprus pubmed.ncbi.nlm.nih.gov

The expression of ANXA3 and its relationship with the occurrence and development of breast cancer. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Annexin A3 as a potential target for immunotherapy of liver cancer stem-like cells. [2016]

10. Switzerland pubmed.ncbi.nlm.nih.gov

ANO1 Expression Orchestrates p27Kip1/MCL1-Mediated Signaling in Head and Neck Squamous Cell Carcinoma. [2021]