What side effects are associated with this type of intervention?

Common treatments for Non-Hodgkin's Lymphoma, such as chemotherapy, immunotherapy, and targeted therapy, have various side effects. Chemotherapy often causes nausea, vomiting, fatigue, hair loss, and increased infection risk. Immunotherapy, like rituximab, can result in infusion reactions, fever, chills, and fatigue. Targeted therapies, such as ibrutinib, may lead to diarrhea, bleeding, and cardiovascular issues like atrial fibrillation. Treatments similar to ATG-101, a novel anti-cancer agent, may exhibit a combination of these side effects along with potential unique reactions specific to its mechanism.

What prior FDA approvals exist?

The FDA has approved several treatments for Non-Hodgkin's Lymphoma, including monoclonal antibodies and targeted therapies. Rituximab, a monoclonal antibody targeting CD20, was one of the first significant approvals and is often used in combination with chemotherapy. Other notable approvals include obinutuzumab, another anti-CD20 monoclonal antibody, and CAR T-cell therapies like axicabtagene ciloleucel and tisagenlecleucel, which are used for certain types of relapsed or refractory NHL. These treatments, like the novel agent ATG-101, represent advancements in targeted and immunotherapy approaches for NHL.

What other types of research exist?

Promising novel alternatives to ATG-101 for Non-Hodgkin's Lymphoma patients include pembrolizumab, which has shown efficacy in various lymphomas and solid tumors, and AT9283, an aurora kinase inhibitor with antitumor activity. Both agents are being investigated in clinical trials and have demonstrated potential in treating advanced malignancies.

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Cancer Vaccine

ATG-101 for Advanced Cancers (PROBE Trial)

Phase 1

Recruiting

Research Sponsored by Antengene Biologics Limited

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

Aged at least 18 years as of the date of consent.

Must not have

Radiotherapy with a wide field of radiation within 28 days.

Prior organ allograft transplantations.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year after last patient first dose

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called ATG-101 on patients with advanced cancers to see if it can help treat their condition.

Who is the study for?

This trial is for adults with advanced solid tumors or mature B-cell Non-Hodgkin Lymphomas that have worsened after standard treatment, can't tolerate it, or have no suitable standard options. Participants must be expected to live at least 12 weeks and be in fairly good health (ECOG status 0-1). They should use birth control.

What is being tested?

The study tests ATG-101, a new potential cancer drug. It's the first time this drug is being tried in humans (Phase I) to see how safe it is and how well it works against certain cancers that are either spreading (metastatic) or cannot be removed by surgery.

What are the potential side effects?

Since ATG-101 is new and this is its first trial in humans, specific side effects aren't known yet. However, participants will be closely monitored for any reactions related to the immune system due to the nature of ATG-101 targeting proteins involved in cancer growth.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am 18 years old or older.

Exclusion Criteria

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

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I have not had extensive radiotherapy in the last 28 days.

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I have had an organ transplant from another person.

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I do not have brain tumors or cancer that has spread to my brain.

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I do not have an active infection, including hepatitis B or C.

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I have previously received ATG-101 or a 4-1BB agonist treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year after last patient first dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year after last patient first dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year after last patient first dose for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

AEs

DLT (for Dose Escalation Phase only)

SAEs

Secondary study objectives

DCR

DOR

ORR

+4 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single experimental arm for ATG-101Experimental Treatment1 Intervention

Subjects with advanced or metastatic solid tumors and mature B-NHLs will be enrolled.

0 / 7Eligibility 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

The most common treatments for Non-Hodgkin's Lymphoma (NHL) include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, including cancer cells, but can also affect normal cells, leading to side effects. Targeted therapies, such as monoclonal antibodies, specifically target cancer cell markers (e.g., CD20 on B-cells) to destroy malignant cells while sparing normal cells. Immunotherapy, including immune checkpoint inhibitors, enhances the body's immune response against cancer cells. These mechanisms are crucial for NHL patients as they offer different strategies to combat the disease, potentially improving outcomes and reducing side effects. The novel agent ATG-101, being studied in clinical trials, likely involves a targeted or immunotherapeutic approach, aiming to provide a more effective and specific treatment option for patients with advanced or metastatic NHL.