What is the mechanism of action of this treatment?

Common treatments for Lymphoma include chemotherapy, targeted therapy, immunotherapy, and radiation therapy. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cancer cells. Targeted therapies, such as monoclonal antibodies, specifically target cancer cell markers, minimizing damage to normal cells. Immunotherapy boosts the body's immune system to recognize and destroy cancer cells. Radiation therapy uses high-energy rays to kill cancer cells in localized areas. Anti-tumor agents like AN4005 work by inhibiting specific pathways essential for tumor growth and survival. Understanding these mechanisms is crucial for Lymphoma patients as it helps in selecting the most effective treatment with the least side effects, improving overall outcomes and quality of life.

What side effects are associated with this type of intervention?

Common treatments for lymphoma, particularly those involving anti-tumor agents like rituximab and bendamustine, often result in side effects such as infusion reactions, neutropenia, anemia, nausea, fatigue, and an increased risk of infections. Specific agents may also cause unique side effects, such as cardiotoxicity with anthracyclines and peripheral neuropathy with vinca alkaloids.

What prior FDA approvals exist?

The FDA has approved several treatments for lymphoma, including monoclonal antibodies like rituximab, ofatumumab, and obinutuzumab, which target CD20 on B cells. Additionally, small molecule inhibitors such as idelalisib, which targets PI3K, have been approved for certain types of lymphoma. These treatments are similar to the anti-tumor agent AN4005 being studied, as they focus on targeting specific pathways or markers on cancer cells to inhibit tumor growth and proliferation.

What other types of research exist?

A promising novel alternative to AN4005 for lymphoma patients is ADCT-402 (loncastuximab tesirine). This antibody-drug conjugate targets CD19 and has shown preliminary clinical activity and safety in a phase I study for relapsed/refractory B-cell non-Hodgkin lymphoma. It is a potential option for patients considering treatment in 2024.

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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

Must not have

History of (non-infectious) pneumonitis requiring steroids or current pneumonitis

Uncontrolled tumor-related pain

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, AN4005, in patients with advanced tumors. It aims to find the highest safe dose by adjusting the amount given over time.

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.

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).

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had pneumonitis treated with steroids or have it now.

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I have pain from my cancer that isn't relieved by treatment.

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I had palliative radiotherapy less than 2 weeks ago.

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I stopped my previous cancer treatment because of severe side effects.

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I frequently need procedures to remove excess fluid from my chest or abdomen.

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I have had a tissue or organ transplant in the last 5 years.

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My cancer has spread to the lining of my brain and spinal cord.

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I am currently taking medication that affects how drugs are processed in my body.

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It's been over 6 weeks since my CAR-T cell therapy and there are no remaining CAR-T cells in my blood.

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I cannot take pills by mouth or have a severe gut condition.

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I have active tuberculosis.

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I have not had major surgery in the last 4 weeks.

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I have untreated or unstable pressure on my spinal cord.

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I have an immune system disorder or am on long-term steroids or immune-suppressing drugs.

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I have a serious heart condition.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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).

0 / 22Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Lymphoma include chemotherapy, targeted therapy, immunotherapy, and radiation therapy. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cancer cells. Targeted therapies, such as monoclonal antibodies, specifically target cancer cell markers, minimizing damage to normal cells. Immunotherapy boosts the body's immune system to recognize and destroy cancer cells. Radiation therapy uses high-energy rays to kill cancer cells in localized areas. Anti-tumor agents like AN4005 work by inhibiting specific pathways essential for tumor growth and survival. Understanding these mechanisms is crucial for Lymphoma patients as it helps in selecting the most effective treatment with the least side effects, improving overall outcomes and quality of life.