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AN0025 + Chemoradiation for Lung Cancer

Phase 1
Waitlist Available
Led By Salma K Jabbour, MD
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be fully active, able to carry on all pre-disease performance without restriction or restricted in physically strenuous activity but able to carry out work of a light or sedentary nature (e.g., light house work, office work)
Female participants of childbearing potential should be willing to use two methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication
Must not have
Have a history of interstitial lung disease
Significant cardiovascular impairment: history of congestive heart failure, uncontrolled arterial hypertension, unstable angina, myocardial infarction, or stroke within 6 months of the first dose of study drug; or cardiac arrhythmia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing the safety and effectiveness of a new drug, AN0025, for treating cancer. The drug will be given to patients in two different ways: after chemoradiation therapy, and during chemoradiation therapy. The trial will measure how well the drug works by looking at how long patients live without the cancer progressing, the percentage of patients whose cancer shrinks, and other measures.

Who is the study for?
This trial is for adults over 18 with Stage III Non-Small Cell Lung Cancer who can perform daily activities, have adequate organ function and lung capacity. They must not be pregnant or breastfeeding, agree to use contraception, and cannot have a second active cancer or severe allergies to the treatment components.
What is being tested?
The trial tests AN0025's safety and effectiveness when given during and after chemoradiation therapy in patients with Stage III NSCLC. It looks at how well it works by measuring time without disease progression, response rate, survival times, and drug levels in the body.
What are the potential side effects?
While specific side effects of AN0025 are not listed here, common ones from similar treatments include fatigue, nausea, skin reactions from radiation, immune-related conditions due to immunotherapy drugs like durvalumab (which may also be part of this study), as well as potential blood count changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can do my usual activities or only light work due to my condition.
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I am using two birth control methods or am not having sex to join this study.
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I am 18 years old or older.
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I do not have any other ongoing cancers.
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I have provided a sample of my tumor that has not been treated with radiation.
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My lung cancer is advanced and cannot be removed by surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of lung scarring or fibrosis.
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I do not have serious heart problems like recent heart failure or uncontrolled high blood pressure.
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I weigh less than 66 lbs.
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My cancer has spread to my brain or spinal cord.
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I am currently being treated for an infection.
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I have not had major surgery in the last 4 weeks.
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I have an immune system disorder or have been on steroids or other immune-weakening drugs in the last week.
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I am under 18 years old.
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I have not received a live vaccine in the last 30 days.
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I stopped an immunotherapy treatment due to severe side effects.
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I have inflammatory bowel disease.
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I have received a transplant from another person.
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I have had or currently have lung inflammation treated with steroids.
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I cannot take pills by mouth or have uncontrolled stomach issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two years
This trial's timeline: 3 weeks for screening, Varies for treatment, and two years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Eastern Cooperative Oncology Group Performance Status (ECOGPS) to measure how participants disease is progressing
Secondary study objectives
Immune response evaluation criteria in solid tumors( iRECIST) to measure the progression of disease
Other study objectives
Neoplasms

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: AN0025: Dose level two: 375 mg dailyExperimental Treatment1 Intervention
Oral, given two hours before chemotherapy or durvalumab; Patients should fast two hours before and one hour after AN0025 administration
Group II: AN0025: Dose level one: 250 mg dailyExperimental Treatment1 Intervention
Oral, given two hours before chemotherapy or durvalumab; Patients should fast two hours before and one hour after AN0025 administration

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor
455 Previous Clinical Trials
69,927 Total Patients Enrolled
Adlai Nortye Biopharma Co., Ltd.Industry Sponsor
7 Previous Clinical Trials
716 Total Patients Enrolled
Salma K Jabbour, MDPrincipal InvestigatorRutgers Cancer Institute of New Jersey

Media Library

AN0025 Clinical Trial Eligibility Overview. Trial Name: NCT05358691 — Phase 1
Lung Cancer Research Study Groups: AN0025: Dose level two: 375 mg daily, AN0025: Dose level one: 250 mg daily
Lung Cancer Clinical Trial 2023: AN0025 Highlights & Side Effects. Trial Name: NCT05358691 — Phase 1
AN0025 2023 Treatment Timeline for Medical Study. Trial Name: NCT05358691 — Phase 1
~16 spots leftby Dec 2027
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