ANS014004 for Cancer

Recruiting at 8 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

63 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a Phase 1, first-in-human, open-label, multi-center study with the aim of exploring the safety, tolerability, PK, and preliminary anti-tumor activity of ANS014004 as a single agent in participants with locally advanced or metastatic solid tumors.

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.

Research Team

Medical Director Clinical Science

Principal Investigator

Beijing Avistone Biotechnology Co., Ltd.

Eligibility Criteria

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.

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: ANS014004 Monotherapy Experimental Treatment 1 Intervention

Part 1 aims to determine the safety, tolerability, maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of ANS014004. Part 2 aims to determine the safety, tolerability and evaluate anti-tumor activity of ANS014004 as monotherapy in select solid tumors.

Who Is Running the Clinical Trial?

Avistone Biotechnology Co., Ltd.

Lead Sponsor

Trials

10

Recruited

1,400+