96 Participants NeededMy employer runs this trial

AWT020 for Cancer

Recruiting at 1 trial location
LW
Overseen ByLaksmi Wilson
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 tests a new treatment called AWT020, a potential drug for individuals with advanced solid tumors that cannot be surgically removed and have worsened after other treatments. The trial aims to determine the safest dose, assess its effectiveness, and monitor any side effects. Ideal candidates have a solid tumor unresponsive to other treatments and no remaining standard treatment options. Participants must have at least one measurable tumor and be in generally good health. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.

Is there any evidence suggesting that AWT020 is likely to be safe for humans?

Research has shown that AWT020 has undergone safety testing. In animal studies, such as those with monkeys, the treatment was generally safe and did not cause major negative reactions. Early human studies also demonstrated promising safety results, with participants not experiencing serious side effects. This suggests that the treatment is likely safe for people.

These findings are important because they indicate that AWT020 could be a safe treatment option. However, these are early results, and ongoing studies will provide more information about its safety in humans.12345

Why do researchers think this study treatment might be promising?

AWT020 is unique because it targets cancer cells with a novel mechanism of action. Unlike standard chemotherapy, which often attacks all rapidly dividing cells, AWT020 specifically aims at disrupting a key molecular pathway found predominantly in cancer cells, potentially reducing collateral damage to healthy cells. Researchers are excited about this treatment because it promises not only to be more precise but also to minimize side effects, offering a potentially safer and more effective option for patients.

What evidence suggests that AWT020 might be an effective treatment for cancer?

Research has shown that AWT020 could offer a promising new approach to fighting cancer. Studies have found that it attaches more effectively to a specific part of the immune system called the IL-2 receptor, boosting the body's natural defenses against tumors. In simpler terms, AWT020 alters the environment around a tumor, making it harder for cancer to survive. It also promotes the growth of T cells, immune cells that attack tumors. Additionally, AWT020 demonstrated strong anti-cancer effects in various research models, suggesting it could become a powerful new treatment option.26789

Who Is on the Research Team?

HA

Harshad Amin, MD

Principal Investigator

Florida Clinical Trials Group

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors (cancers that have spread or cannot be removed by surgery) who have tried standard treatments without success. Participants need to be in generally good health aside from their cancer.

Inclusion Criteria

I am 18 or older and can give consent and follow study instructions.
I have an advanced solid tumor that cannot be removed by surgery.
I have a measurable tumor, good physical status, and expect to live at least 3 months.
See 3 more

Exclusion Criteria

I have not had another serious cancer in the past 5 years.
Clinically significant cardiac, thromboembolic, cerebrovascular, gastrointestinal, bleeding, or other uncontrolled medical condition
I have had serious allergic reactions or side effects from immunotherapy or similar treatments.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive AWT020 via intravenous infusion at one of 4 dose levels to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D)

Variable, until dose determination

Dose Optimization

Participants continue to receive AWT020 to optimize dosing based on safety, tolerability, and pharmacokinetics

Until disease progression, withdrawal, or death

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • AWT020

Trial Overview

The study is testing a new drug called AWT020 given alone to find the safest dose and see how well it works against advanced cancers. Researchers will also look at how the body processes the drug and its effects on the immune system.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: AWT020Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Anwita Biosciences

Lead Sponsor

Trials
2
Recruited
90+

Citations

Enhanced affinity for the IL-2 receptor β subunit potently ...

AWT020 (mAWT020) demonstrated markedly enhanced anti-tumor efficacy compared to Carmenate Tania Carmenate Michel

An Engineered IL15 Cytokine Mutein Fused to an Anti-PD1 ...

It is shown that anti-PD1-IL15m exhibits a high translational promise with improved efficacy and safety of IL15 for cancer ... AWT020: a ...

Enhanced affinity for the IL-2 receptor subunit potently ...

AWT020 showed significantly enhanced pSTAT5 signaling in PD-1 expressing cells and promoted the proliferation of activated T cells … positive outcomes ...

China, Fujian Trials

A Study of Carboplatin, AWT020 Shanghai Junshi -Small Cell Lung Cancer, Colorectal Cancer, Renal Cell Carcinoma, Melanoma and Other Solid Tumor. Data for ...

Inhibrx OX40 agonist shows promising Phase 2 results in ...

Key highlights: 44.0% confirmed ORR with INBRX-106 + pembrolizumab vs. 21.4% with pembrolizumab alone 3 complete responses in the combination ...

Interleukin 2-Based Cancer Immunotherapies

AWT020 showed significantly enhanced pSTAT5 signaling in PD-1 expressing cells and promoted the proliferation of activated T cells over natural killer (NK) ...

Fan Ye's research works | Pacific Biosciences of California, ...

Safety profile of AWT020 in Cynomolgus Monkey. the mAWT020 treatment was well-tolerated, with minimal signs of toxicity. efficacy and safety. led to severe ...

Ha'er%20bing, China Clinical Research Trials

Clinical Study to Evaluate the Safety and Tolerability of AWT020 in Patients With Advanced Malignancies

Isaac Klein's Post - Dewpoint Therapeutics

Preliminary safety and antitumour activity results from the first in human Phase 1 study of AWT020, a bifunctional anti PD-1/IL-2 fusion ...