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AGEN1571

Phase 1

Advanced Solid Tumor | Small molecule | Oncology |Agenus Inc.|Trials Updated: Apr 30, 2025

AGEN1571 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since May 2022

AGEN1571 target and mechanism

Molecular targetILT2
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment22

FDA Designations

No designations recorded

AGEN1571 clinical trials

AGEN1571 · 1 trial · 1 indication

Phase 1 1
NCT05377528Study of AGEN1571 in Participants With Advanced Solid TumorsAdvanced Solid Tumor
COMPLETED22 Analytics
PHASE1COMPLETED
Study of AGEN1571 in Participants With Advanced Solid Tumors
Advanced Solid TumorUnlock trial analytics

Study Endpoints

Primary Endpoints

Number Of Participants With Dose-limiting Toxicities
Day 1 through Day 42
Number Of Participants With Treatment-emergent Adverse Events
Day 1 up to 12 months after the last dose

Secondary Endpoints

Serum AGEN1571 Concentration
Day 1 up to 90 days after the last dose
Serum Balstilimab Concentration
Day 1 up to 90 days after the last dose
Serum Botensilimab Concentration
Day 1 up to 90 days after the last dose
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose Escalation: AGEN1571EXPERIMENTALParticipants will receive AGEN1571 monotherapy.
Dose Escalation: AGEN1571 + BalstilimabEXPERIMENTALParticipants will receive AGEN1571 with balstilimab.
Dose Escalation: AGEN1571 + BotensilimabEXPERIMENTALParticipants will receive AGEN1571 with botensilimab.
Dose Escalation: AGEN1571 + Balstilimab + BotensilimabEXPERIMENTALParticipants will receive AGEN1571 with balstilimab and botensilimab.
Dose ExpansionEXPERIMENTALAGEN1571 administered at the RP2D for monotherapy or any combination therapy.

Interventions

NameTypeDescription
AGEN1571DRUGA fully human monoclonal immunoglobulin-like transcript antagonist antibody administered intravenously.
BalstilimabDRUGA fully human monoclonal programmed cell death protein 1 antagonist antibody administered intravenously.
BotensilimabDRUGA fully human fragment crystallizable-enhanced monoclonal cytotoxic T lymphocyte antigen 4 antibody administered intravenously.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: 1. Voluntarily agree to participate by giving signed, dated, and written informed consent prior to any study-specific procedures (participation in genetic testing is optional). 2. Histologically confirmed diagnosis of a solid tumor that is currently metastatic or locally advance...

Countries:United States
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Competitive Landscape -Other Solid Tumors 10 trials (matched to "Advanced Solid Tumor")

Frequently asked questions about AGEN1571

What is AGEN1571?

AGEN1571 is an investigational small molecule developed by Agenus Inc. for the treatment of advanced solid tumors. It is designed to target ILT2, a protein receptor involved in immune regulation. AGEN1571 has been studied in a Phase 1 clinical trial and is not approved for any indication.

What is AGEN1571 used for in advanced solid tumors?

AGEN1571 is being developed for the treatment of advanced solid tumors. It is an investigational therapy and has not been approved for any cancer indication. The Phase 1 study enrolled 22 participants with advanced solid tumors in the United States to evaluate the drug in this patient population.

What does AGEN1571 target?

AGEN1571 targets ILT2, a protein receptor. ILT2 is an inhibitory receptor expressed on certain immune cells, and targeting it is intended to modulate immune responses against tumors. The drug is a small molecule designed to bind ILT2 as part of its mechanism in advanced solid tumor treatment.

Who is developing AGEN1571?

AGEN1571 is being developed by Agenus Inc., a biopharmaceutical company whose common stock trades under the ticker symbol AGEN. Agenus is responsible for the clinical development of the drug, including the completed Phase 1 trial in participants with advanced solid tumors.

What phase is AGEN1571 in?

AGEN1571 is in Phase 1 clinical development. A Phase 1 trial has been completed, evaluating the drug in participants with advanced solid tumors. The study enrolled 22 participants and was conducted in the United States. AGEN1571 is investigational and has not received FDA approval.

What clinical trials is AGEN1571 in?

AGEN1571 has been evaluated in one clinical trial, NCT05377528, titled Study of AGEN1571 in Participants With Advanced Solid Tumors. This Phase 1 trial is completed and enrolled 22 participants with advanced solid tumors in the United States. It was a controlled study without randomization or double blinding.