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AGEN1571

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment22

FDA Designations

No designations recorded

Clinical trial landscape

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 9 trials (matched to "Advanced Solid Tumor")

Frequently asked questions about AGEN1571

What is AGEN1571 used for?

AGEN1571 is an investigational small molecule being developed for the treatment of advanced solid tumors. It is currently in clinical development and has not been approved by regulatory authorities. The drug is being studied in patients with advanced solid tumor malignancies.

Who makes AGEN1571?

AGEN1571 is being developed by Agenus Inc., a biopharmaceutical company. Agenus Inc. is publicly traded on the NASDAQ under the ticker symbol AGEN. The company is conducting clinical research to evaluate the safety and efficacy of AGEN1571 in patients with advanced solid tumors.

What phase is AGEN1571 in?

AGEN1571 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The Phase 1 study of AGEN1571 has been completed, and the drug remains in early-stage clinical development for advanced solid tumors.

What clinical trials is AGEN1571 in?

AGEN1571 has been studied in one clinical trial, identified as NCT05377528, titled "Study of AGEN1571 in Participants With Advanced Solid Tumors." This Phase 1 trial was conducted in the United States and enrolled 22 participants aged 18 years and older. The trial has been completed.

Is AGEN1571 the same as any other drug?

No alternative names for AGEN1571 have been identified. The drug is known by its code name AGEN1571 and is being developed by Agenus Inc. It is a distinct investigational small molecule being studied for the treatment of advanced solid tumors.