AGEN1571 + Immunotherapy for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new cancer treatment called AGEN1571, both alone and in combination with other drugs, to assess its safety and effectiveness. It targets individuals with advanced solid tumors who have not responded to standard treatments. The trial consists of two parts: one to determine the appropriate dose and another to evaluate the treatment's effectiveness in specific cancers. Ideal participants have a solid tumor that has spread or cannot be surgically removed and have tried other treatments without success. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, there are specific 'washout' periods (time without taking certain medications) for some treatments before starting the trial. It's best to discuss your current medications with the trial team to see if any adjustments are needed.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that AGEN1571 is being tested for safety in individuals with advanced solid tumors, both alone and in combination with other drugs. Early studies primarily aim to determine a safe dose. Although specific data on AGEN1571 alone is limited, research involving the drugs botensilimab and balstilimab, used alongside AGEN1571, indicates a generally manageable safety profile.
In one study with 63 patients using the botensilimab and balstilimab combination, 52% experienced immune-related side effects. These effects mirrored those observed in previous studies, suggesting they are predictable and manageable. Another study found this combination to be well-tolerated, with no new safety concerns.
As this trial is in its early stages, the primary goal is to assess how the body handles the drug and to identify the appropriate dose. While safety information may still be limited, the focus remains on ensuring the drug is well-tolerated before advancing to more complex trial phases.12345Why are researchers excited about this trial's treatments?
Unlike the standard cancer treatments like chemotherapy and radiotherapy, which can affect both healthy and cancerous cells, AGEN1571 and its combinations take a more targeted approach. These treatments are exciting because they utilize novel mechanisms to boost the immune system's natural ability to fight cancer. AGEN1571, when combined with balstilimab or botensilimab, potentially enhances immune responses more effectively than existing options by specifically targeting and modulating immune checkpoints. Researchers are particularly hopeful that these therapies can improve outcomes with fewer side effects, offering a more precise strike against cancer cells without harming healthy tissues.
What evidence suggests that this trial's treatments could be effective for advanced solid tumors?
Research has shown that AGEN1571 could be a promising treatment for advanced solid tumors. In earlier studies, AGEN1571, which targets a part of the immune system called ILT2, helped control the disease in 65.4% of cases and improved survival rates. In this trial, participants may receive AGEN1571 alone or with other drugs. When combined with botensilimab and balstilimab, AGEN1571 also showed potential benefits. Previous trials with these combinations reported that 42% of patients with certain hard-to-treat cancers survived for at least two years. In some cases, the combination of botensilimab and balstilimab even led to a complete disappearance of the cancer. These findings suggest that AGEN1571, whether used alone or with other drugs, could effectively treat solid tumors.13678
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive AGEN1571 as monotherapy or in combination with balstilimab and/or botensilimab to determine the recommended phase 2 dose (RP2D)
Dose Expansion
Participants receive AGEN1571 at the RP2D for specific disease indications
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AGEN1571
- Balstilimab
- Botensilimab
Trial Overview
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.
How Is the Trial Designed?
5
Treatment groups
Experimental Treatment
AGEN1571 administered at the RP2D for monotherapy or any combination therapy.
Participants will receive AGEN1571 with botensilimab.
Participants will receive AGEN1571 with balstilimab and botensilimab.
Participants will receive AGEN1571 with balstilimab.
Participants will receive AGEN1571 monotherapy.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Agenus Inc.
Lead Sponsor
Citations
1.
aacrjournals.org
aacrjournals.org/cancerres/article/82/12_Supplement/2906/700377/Abstract-2906-AGEN1571-is-a-novel-high-affinityAGEN1571 is a novel high-affinity ILT2 antagonist antibody ...
These data support clinical development of AGEN1571 as a therapeutic agent for patients with solid tumors. Citation Format: Olga Udartseva, ...
Study of AGEN1571 in Participants With Advanced Solid ...
This is an open-label, Phase 1, 2-part trial to determine recommended phase 2 doses (RP2Ds) and evaluate the safety, tolerability, pharmacokinetic, ...
3.
investor.agenusbio.com
investor.agenusbio.com/news/news-details/2025/Agenus-Reports-Impact-of-Key-Immuno-Oncology-Data-Presented-at-Leading-Medical-Conferences-and-Peer-Reviewed-Publications/default.aspxAgenus Reports Impact of Key Immuno-Oncology Data ...
The disease control rate (DCR) reached 65.4%, with a median progression-free survival (PFS) of 4.4 months and a 12-month overall survival (OS) ...
Agenus Presents Data on AGEN1571 (anti-ILT2) at AACR ...
First data presentation on AGEN1571 shows strong adaptive and innate immune responses; Preclinical data indicate superior performance to the ...
5.
biospace.com
biospace.com/agenus-announces-first-patient-dosed-in-phase-1-study-of-agen1571-anti-ilt2-in-advanced-solid-tumorsAgenus Announces First Patient Dosed in Phase 1 Study of ...
The initiation of the AGEN1571 study in patients with advanced solid tumors is based on preclinical data reported at the American Association ...
AGEN1571 is a novel high-affinity ILT2 antagonist antibody ...
Cumulative data for gastric (n=4), kidney (n=11) and lung (n=8) cancer specimens are shown. (C) Profile of HLA-G and PD-L1 expression on non-hematopoietic (CD45 ...
AGEN-1571 - Drug Targets, Indications, Patents
Agenus filed it for an accelerated approval in cervical cancer in October 2021 only to withdraw the application when the market closed upon the full approval of ...
Agenus Announces First Patient Dosed in Phase 1 Study of ...
Study will evaluate safety and tolerability of AGEN1571 as a single agent and in combination with botensilimab and balstilimab.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.