What side effects are associated with this type of intervention?

Common treatments for solid tumors, particularly those involving immune checkpoint inhibitors like PD-1 inhibitors, often result in side effects such as fatigue, rash, diarrhea, and pruritus. More severe immune-mediated effects can include pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. Combination therapies may heighten these risks and add new side effects, such as increased infection risk and hematologic toxicities.

What prior FDA approvals exist?

The FDA has approved several immune checkpoint inhibitors for the treatment of solid tumors. Notable examples include pembrolizumab (Keytruda) and nivolumab (Opdivo), both of which target the PD-1 pathway and have been approved for various cancers such as melanoma, non-small cell lung cancer, and renal cell carcinoma. Additionally, combination therapies involving these agents, such as nivolumab with ipilimumab (Yervoy), have also received FDA approval for enhanced efficacy in treating advanced solid tumors. These treatments are similar to the investigational combinations being studied with AGEN1571.

What other types of research exist?

Promising novel alternatives to AGEN1571 for solid tumor patients include: 1) Pembrolizumab (Keytruda) - an anti-PD-1 therapy showing efficacy in various solid tumors. 2) Nivolumab (Opdivo) combined with Ipilimumab (Yervoy) - a combination of immune checkpoint inhibitors effective in several cancers. 3) Atezolizumab (Tecentriq) plus Bevacizumab (Avastin) - particularly for renal cell carcinoma and other solid tumors. 4) Dabrafenib plus Trametinib - for tumors with BRAFV600E mutations. These agents have demonstrated significant clinical benefits and are expected to be key options in 2024.

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Monoclonal Antibodies

AGEN1571 + Immunotherapy for Cancer

Phase 1

Waitlist Available

Research Sponsored by Agenus Inc.

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group performance status of 0 or 1

Histologically confirmed diagnosis of a solid tumor that is currently metastatic or locally advanced for which no standard therapy is available or standard therapy has failed

Must not have

Persistent toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 Grade >1 severity related to prior therapy

Uncontrolled hypertension or controlled hypertension on more than 3 antihypertensive agents

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 up to 90 days after the last dose

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called AGEN1571 alone and with two other drugs in patients with advanced solid tumors. The goal is to find safe doses and see how well the drugs work. The drugs aim to either directly attack cancer cells or help the immune system fight them.

Who is the study for?

This trial is for adults with advanced solid tumors that have spread or are inoperable, and no standard treatments work or exist. They must be relatively healthy otherwise, with a life expectancy of at least 3 months and good organ function. Women who can have children and men with partners who can conceive must use effective birth control. People cannot join if they've had certain severe reactions to similar drugs, recent other treatments, active infections including HIV/HBV/HCV, significant heart issues, or uncontrolled high blood pressure.

What is being tested?

The study tests AGEN1571 alone and combined with balstilimab/botensilimab in two parts: first finding the right doses (dose escalation), then seeing how well these work on specific tumor types (dose expansion). Participants will receive treatment up to two years unless their disease worsens or side effects become too much.

What are the potential side effects?

Possible side effects include reactions related to the immune system attacking normal cells by mistake (autoimmune reactions), infusion-related symptoms like fever or chills during drug administration, fatigue, liver problems due to medication processing demands on the body's detox systems.

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 can carry out light work.

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My cancer is advanced or has spread, and standard treatments have failed or are not available.

Exclusion Criteria

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

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I have lasting side effects from previous treatments that are moderate or worse.

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My high blood pressure is not well-controlled, or I take more than 3 medications for it.

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I am legally not allowed or limited in making my own decisions.

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I am HIV positive or have active hepatitis B or C.

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I have had a transplant, but it was not a corneal transplant.

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I have not had recent chemotherapy, biological therapy, radiotherapy, or major surgery.

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I have a serious heart condition.

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My brain metastases are treated and stable.

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I do not have an active infection or lung disease needing treatment recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 up to 90 days after the last dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 up to 90 days after the last dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 up to 90 days after the last dose for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Complete Response (CR) Rate

Disease Control Rate (DCR)

Duration Of Response (DOR)

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

5Treatment groups

Experimental Treatment

Group I: Dose ExpansionExperimental Treatment3 Interventions

AGEN1571 administered at the RP2D for monotherapy or any combination therapy.

Group II: Dose Escalation: AGEN1571 + BotensilimabExperimental Treatment2 Interventions

Participants will receive AGEN1571 with botensilimab.

Group III: Dose Escalation: AGEN1571 + Balstilimab + BotensilimabExperimental Treatment3 Interventions

Participants will receive AGEN1571 with balstilimab and botensilimab.

Group IV: Dose Escalation: AGEN1571 + BalstilimabExperimental Treatment2 Interventions

Participants will receive AGEN1571 with balstilimab.

Group V: Dose Escalation: AGEN1571Experimental Treatment1 Intervention

Participants will receive AGEN1571 monotherapy.

0 / 11Eligibility 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 solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but also affects normal cells, leading to side effects. Targeted therapy involves drugs designed to target specific molecules involved in cancer growth and spread, such as HER2 or EGFR, offering more precise treatment with potentially fewer side effects. Immunotherapy, including PD-1 inhibitors like balstilimab, enhances the body's immune system to recognize and attack cancer cells. Understanding these mechanisms helps patients and doctors choose the most effective treatment with the best balance of efficacy and side effects, tailored to the specific characteristics of the tumor.

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