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AN0025 + Pembrolizumab for Advanced Cancer
Phase 1
Waitlist Available
Research Sponsored by Adlai Nortye Biopharma Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have progressed on treatment with an anti-PD-1/PD-L1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies
Have measurable disease per RECIST 1.1 as assessed by the local site investigator and/or radiologist
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing a new combination drug to treat advanced tumors. The goal is to find the best dose of the new drug while monitoring side effects. The trial will last for two years.
Who is the study for?
This trial is for adults with certain advanced solid tumors who've had no more than 3 prior systemic therapies and have progressed after anti-PD-1/PD-L1 treatment. They must have good organ function, measurable disease, an ECOG status of 0 or 1, a life expectancy over 3 months, and agree to contraception use. Exclusions include recent other cancer treatments, severe allergies to study drugs, active pneumonitis or autoimmune diseases requiring treatment in the last two years.Check my eligibility
What is being tested?
The trial tests AN0025 combined with pembrolizumab on patients with advanced/metastatic tumors. It includes initial observation for dose-limiting toxicity followed by expansion phase treatment up to approximately two years or until disease progression or unacceptable side effects occur.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as inflammation in various organs (like lungs), infusion-related reactions, fatigue, digestive issues possibly leading to diarrhea or colitis-like symptoms, skin rashes and potential increase in risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has worsened despite treatment with specific immune therapy.
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My cancer can be measured by scans.
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My cancer is advanced and cannot be removed by surgery.
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I have had 3 or fewer treatments for my advanced illness.
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I have given a sample of my tumor that was not treated with radiation.
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I am fully active or can carry out light work.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Measure
Secondary outcome measures
Duration of Response (DOR)
Efficacy by PD-L1 expression
ORR and Progression-Free Survival (PFS) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
+1 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
6Treatment groups
Experimental Treatment
Group I: Phase 1b: Urothelial carcinoma of the bladderExperimental Treatment2 Interventions
Patients will receive AN0025 orally once daily (QD); Pembrolizumab, 200mg as an intravenous infusion over 30 minutes every 3 weeks.
Group II: Phase 1b: Triple-negative breast cancer (TNBC)Experimental Treatment2 Interventions
Patients will receive AN0025 orally once daily (QD); Pembrolizumab, 200mg as an intravenous infusion over 30 minutes every 3 weeks.
Group III: Phase 1b: Non-Small Cell Lung Cancer (NSCLC)Experimental Treatment2 Interventions
Patients will receive AN0025 orally once daily (QD); Pembrolizumab, 200mg as an intravenous infusion over 30 minutes every 3 weeks.
Group IV: Phase 1b: Microsatellite Stable (MSS) Colorectal Cancer (CRC)Experimental Treatment2 Interventions
Patients will receive AN0025 orally once daily (QD); Pembrolizumab, 200mg as an intravenous infusion over 30 minutes every 3 weeks.
Group V: Phase 1b: CervicalExperimental Treatment2 Interventions
Patients will receive AN0025 orally once daily (QD); Pembrolizumab, 200mg as an intravenous infusion over 30 minutes every 3 weeks.
Group VI: Ph1a: Urothelial carcinoma of the bladder and NSCLCExperimental Treatment2 Interventions
Patients will receive AN0025 orally once daily (QD); Pembrolizumab, 200mg as an intravenous infusion over 30 minutes every 3 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,508 Total Patients Enrolled
59 Trials studying Breast Cancer
7,534 Patients Enrolled for Breast Cancer
Adlai Nortye Biopharma Co., Ltd.Lead Sponsor
7 Previous Clinical Trials
677 Total Patients Enrolled
Nathan Lautermilch, Ph.D.Study DirectorADLAI NORTYE USA INC.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has worsened despite treatment with specific immune therapy.I have not taken steroids or immunosuppressants in the last 7 days.I had radiotherapy less than 2 weeks before starting the study treatment.I am a man and agree to use birth control during and for 4 months after treatment.My cancer has spread to my brain or its coverings.You have a strong allergic reaction to any part of the study treatment.My cancer can be measured by scans.I haven't had any cancer except for skin, cervical, or breast cancer that was treated to be cured, in the last 2 years.My organs are functioning well.I am currently on medication for an infection.My cancer is advanced and cannot be removed by surgery.I have had 3 or fewer treatments for my advanced illness.I have had pneumonitis treated with steroids or have it now.I have been treated for an autoimmune disease in the last 2 years.I stopped treatment because of a severe reaction to immunotherapy.I have not had major surgery in the last 4 weeks.I have not received a live vaccine in the last 30 days.I have inflammatory bowel disease.I haven't had cancer treatment or experimental drugs in the last 4 weeks.I have given a sample of my tumor that was not treated with radiation.Your heart's electrical activity takes too long to reset, even when your body's mineral levels are normal.I cannot take pills by mouth due to a digestive issue.I have received an organ or tissue transplant from another person.You have a known mental health or substance abuse problem.I am fully active or can carry out light work.I am 18 years old or older.I have HIV or a history of Hepatitis B or C.I am not pregnant and follow the required birth control measures.You are expected to live for at least 3 more months.Your heart's pumping ability is better than 50% on a heart ultrasound or MUGA scan.I have a serious heart condition.
Research Study Groups:
This trial has the following groups:- Group 1: Ph1a: Urothelial carcinoma of the bladder and NSCLC
- Group 2: Phase 1b: Urothelial carcinoma of the bladder
- Group 3: Phase 1b: Microsatellite Stable (MSS) Colorectal Cancer (CRC)
- Group 4: Phase 1b: Triple-negative breast cancer (TNBC)
- Group 5: Phase 1b: Non-Small Cell Lung Cancer (NSCLC)
- Group 6: Phase 1b: Cervical
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can you elaborate on any investigations involving AN0025 that have already taken place?
"AN0025 was first evaluated in 2010 at City of Hope. Since then, a total of 251 studies have been concluded and 961 are underway with many conducted out of Richmond, Virginia."
Answered by AI
Is the enrollment period for this trial still open?
"According to clinicaltrials.gov, this trial is actively enlisting participants. The trail was first published in August 2020 and has gone through multiple updates as recently as February 2022."
Answered by AI
What therapeutic utility does AN0025 possess?
"AN0025 is a viable treatment for malignant neoplasms, inoperable melanoma, and cases of high microsatellite instability."
Answered by AI
What is the cap on patient recruitment for this medical experiment?
"Affirmative. Clinicaltrials.gov has recorded that this medical study, initially listed on August 20th 2020, is presently recruiting individuals. 84 participants must be enrolled from 3 diverse clinical centres."
Answered by AI
Is AN0025 a safe drug for human consumption?
"The safety rating for AN0025 was conservatively given a score of 1 due to its experimental nature, as this is an early phase trial with limited data regarding efficacy and general security."
Answered by AI
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