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AN4005 for Advanced Cancer
Phase 1
Recruiting
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
5. Subjects with histologically or cytologically confirmed advanced solid tumors that are metastatic or unresectable, or relapsed or refractory (r/r) lymphoma, and for whom standard life-prolonging measures are not available. Types of lymphoma may include, but are not limited to, natural killer (NK)/T-cell lymphoma, classic Hodgkin lymphoma (cHL), peripheral T-cell lymphoma (PTCL), and diffuse large B-cell lymphoma (DLBCL).
Confirmed advanced solid tumors or r/r lymphoma with no standard life-prolonging measures available
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 1 year
Awards & highlights
Study Summary
This trial is a study to find the safest dose of a new drug for people with advanced tumors. It is the first time this drug is being used in humans.
Who is the study for?
Adults with advanced solid tumors or relapsed/refractory lymphoma, who have no standard treatment options left. They must be expected to live at least 3 months, have a performance status of 0 or 1 (able to carry out daily activities), and meet certain organ function criteria. Pregnant or breastfeeding women are excluded, as well as those with recent infections, vaccinations, other treatments, or severe allergies.Check my eligibility
What is being tested?
AN4005 is being tested in various doses on patients with advanced tumors to assess its safety and tolerability. This first-in-human study uses a '3 + 3 design' for dose escalation to find the maximum tolerated dose (MTD) and/or recommended phase two dose (RP2D).See study design
What are the potential side effects?
As this is an early-phase trial for AN4005, specific side effects are not yet fully known but may include typical reactions related to cancer drugs such as nausea, fatigue, allergic reactions, blood count changes and potential organ-specific inflammation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is advanced, cannot be surgically removed, or has not responded to treatment, and there are no standard treatments left for me.
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My cancer is advanced and there are no standard treatments left.
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I agree to use birth control during and for 3 months after my treatment ends.
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My doctor expects me to live for at least 3 more months.
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I am not pregnant, not breastfeeding, and follow birth control guidelines.
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I am fully active or can carry out light work.
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I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with any adverse events (AEs), serious adverse events (SAEs), withdrawal due to AEs, dose interruptions and reductions
Number of participants with clinically significant changes in laboratory parameters, vital signs, physical examination and organ-specific parameters
Number of participants with dose limiting toxicities (DLTs)
Secondary outcome measures
AUC from time zero to the last quantifiable concentration after dosing (AUC[0-t]) of AN4005
AUC over the dosing interval tau (AUC[0-tau]) of AN4005
Accumulation ratio (AR) of AN4005
+11 moreTrial Design
6Treatment groups
Active Control
Group I: AN4005 food effectActive Control1 Intervention
The effect of a high-fat meal on the PK of AN4005 will be evaluated in a separate cohort of approximately 6 patients after a safe and clinically relevant dose is identified during the dose finding part of the study.
Group II: AN4005 dose level 0Active Control1 Intervention
One sentinel patient will be orally dosed at 50 mg AN4005 BID. If this dose for one cycle is deemed to be tolerable upon review of safety data and PK data, the dose of AN4005 will be escalated to next level: dose level 1.
Group III: AN4005 dose level 1Active Control1 Intervention
Three patients will be orally dosed at 100 mg AN4005 BID. Based on the number of DLT events during the first cycle, dosing decisions will be made, including add 3 patients at the same dose level (1 DLT), escalation to dose level 3 (<1/6 DLT), de-escalate to lower dose or stop (>1/6 DLT).
Group IV: AN4005 dose level 2Active Control1 Intervention
Three patients will be orally dosed at 200 mg AN4005 BID. Based on the number of DLT events during the first cycle, dosing decisions will be made, including add 3 patients at the same dose level (1 DLT), escalation to dose level 3 (<1/6 DLT), de-escalate to lower dose or stop (>1/6 DLT).
Group V: AN4005 dose level 3Active Control1 Intervention
Three patients will be orally dosed at 400 mg AN4005 BID. Based on the number of DLT events during the first cycle, dosing decisions will be made, including add 3 patients at the same dose level (1 DLT), escalation to dose level 4 (<1/6 DLT), de-escalate to lower dose or stop (>1/6 DLT).
Group VI: AN4005 dose level 4Active Control1 Intervention
Three patients will be orally dosed at 600 mg AN4005 BID. Based on the number of DLT events during the first cycle, dosing decisions will be made, including add 3 patients at the same dose level (1 DLT), de-escalate to lower dose or stop (>1/6 DLT).
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Who is running the clinical trial?
Adlai Nortye Biopharma Co., Ltd.Lead Sponsor
7 Previous Clinical Trials
709 Total Patients Enrolled
Kevin DryerStudy DirectorAdlai Nortye USA Inc
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had another cancer in the last 2 years, with some exceptions.I have not taken any antibiotics by mouth or IV in the last 2 weeks.I have provided a recent biopsy of my tumor, not previously treated with radiation.Standard treatments are not suitable or tolerable for me.You have a severe allergic reaction to any part of the study treatment.I have had pneumonitis treated with steroids or have it now.I don't have any health issues that could affect the study's results.My cancer is advanced, cannot be surgically removed, or has not responded to treatment, and there are no standard treatments left for me.I haven't had cancer treatment in the last 4 weeks or 5 half-lives.I have pain from my cancer that isn't relieved by treatment.I have no suitable standard treatment options according to my doctor.You have an autoimmune disease that was treated with medication in the past 2 years.My cancer can be with or without visible tumors.My cancer is advanced and there are no standard treatments left.I had palliative radiotherapy less than 2 weeks ago.My cancer may or may not be visible on scans.I stopped my previous cancer treatment because of severe side effects.I have not received a live vaccine in the last 30 days.I have not had an infection needing treatment in the last 2 weeks.I frequently need procedures to remove excess fluid from my chest or abdomen.I have had a tissue or organ transplant in the last 5 years.I agree to use birth control during and for 3 months after my treatment ends.My cancer has spread to the lining of my brain and spinal cord.I am currently taking medication that affects how drugs are processed in my body.It's been over 6 weeks since my CAR-T cell therapy and there are no remaining CAR-T cells in my blood.I cannot take pills by mouth or have a severe gut condition.My doctor expects me to live for at least 3 more months.Your blood must have a certain number of infection-fighting cells called neutrophils.I am not pregnant, not breastfeeding, and follow birth control guidelines.I have active tuberculosis.I am fully active or can carry out light work.I am 18 years or older and have signed the consent form.I am fully active or can carry out light work.My organs are functioning well.I have not had major surgery in the last 4 weeks.I have untreated or unstable pressure on my spinal cord.I have an immune system disorder or am on long-term steroids or immune-suppressing drugs.I am 18 or older and have signed the consent form for this trial.I have a serious heart condition.You have a healthy heart with good pumping action as shown by an echocardiogram or MUGA scan.You agree to follow all the rules of the study.
Research Study Groups:
This trial has the following groups:- Group 1: AN4005 food effect
- Group 2: AN4005 dose level 0
- Group 3: AN4005 dose level 1
- Group 4: AN4005 dose level 2
- Group 5: AN4005 dose level 3
- Group 6: AN4005 dose level 4
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.
What is the cap on enrollees for this clinical trial?
"This trial necessitates 31 participants that meet the appropriate eligibility requirements. Potential patients can partake in this research at either Montefiore Einstein Cancer Center located in Bronx, New york or Prisma Health Institute for Translational Oncology Research situated in Greenville, South carolina."
Answered by AI
What is the primary objective of this experimental endeavor?
"The primary evaluation criteria for this trial, which will occur over the course of one year, is to quantify Dose Limiting Toxicities (DLTs). Secondary outcomes assessed include Oral Clearance (CL/F) and Area Under the Plasma Concentration-Time Curve extrapolated from time zero to infinity (AUC[0-inf]), as well as Overall Response Rate based on Evaluation Criteria In Solid Tumors 1.1(ORR) in participants with solid tumors. Blood samples taken at given intervals will be used to calculate CL/F and AUC[0-inf], while ORR will be scored using investigator assessment"
Answered by AI
How many distinct locations are being maintained to manage this clinical experiment?
"The list of trial sites hosting this clinical study includes Montefiore Einstein Cancer Center in Bronx, New york; Prisma Health Institute for Translational Oncology Research in Greenville, South carolina; and Next Virginia in Fairfax, Virginia. Additionally, 4 additional locations are accommodating patient enrollment."
Answered by AI
Has FDA authorization been granted for the utilization of AN4005 dose level 2?
"The risk associated with AN4005 dose level 2, which is being tested in a Phase 1 trial, was determined to be low and thus given a score of 1."
Answered by AI
Is it still possible to join this experimental research study?
"This medical trial is actively seeking out suitable participants, with the original posting being made on September 27th 2021 and more recently updated on October 20th 2022."
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