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AGEN1777

Phase 1

Advanced Cancer | Small molecule | Oncology |Agenus Inc.|Trials Updated: Oct 15, 2025

AGEN1777 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Aug 2021

AGEN1777 target and mechanism

Molecular targetTIGIT
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

AGEN1777 clinical trials

AGEN1777 · 1 trial · 1 indication

Phase 1 1
NCT05025085A Study Investigating AGEN1777 in Participants With Advanced Solid TumorsAdvanced Cancer
COMPLETED25 Analytics
PHASE1COMPLETED
A Study Investigating AGEN1777 in Participants With Advanced Solid Tumors
Advanced CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants with Dose-Limiting Toxicities (DLT) of AGEN1777 as a Single-Agent and in Combination with a PD-1 inhibitor
Day 1 through Day 21
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Up to 2 years and 90 days

Secondary Endpoints

Maximum Observed Concentration at Steady State (Cmax-ss) of Serum AGEN1777 and a PD-1 inhibitor
Day 1 Up to End of Treatment (up to 2 years)
Serum AGEN1777 Anti-Drug Antibody (ADA) Determination
Day 1 of Cycle 1 (Cycle = 21 days) through Day 1 of Cycle 5. Incidence of ADA
Serum a PD-1 inhibitor Anti-Drug Antibody (ADA) Determination
Day 1 Up to End of Treatment (up to 2 years)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Monotherapy with AGEN1777EXPERIMENTAL3+3 Dose escalation of AGEN1777 will be administered by Intravenous (IV) infusion every 3 weeks (each cycle is 21 days \[3 weeks\]).
AGEN1777 in combination with a PD-1 inhibitorEXPERIMENTAL3+3 Dose escalation of AGEN1777 in combination with a PD-1 inhibitor will be administered by IV infusion with specified dose on specified days.

Interventions

NameTypeDescription
AGEN1777DRUGAn immunoglobulin gamma (IgG1) antibody
a PD-1 inhibitorDRUGAnti-programmed cell death protein 1 (Anti-PD-1) antibody monoclonal antibody
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites11

Key Inclusion Criteria: 1. Histologically or cytologically confirmed diagnosis of metastatic or locally advanced solid tumor for which no acceptable standard therapy available or progressed on or after standard therapies. 2. Measurable disease on baseline imaging based on Response Evaluation Criter...

Countries:United States
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Competitive Landscape -Cancer 7 trials (matched to "Advanced Cancer")

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Frequently asked questions about AGEN1777

What is AGEN1777 used for?

AGEN1777 is an investigational small molecule being studied for the treatment of advanced cancer, including advanced solid tumors. It is being developed by Agenus Inc. and has been evaluated in a Phase 1 clinical trial in participants with advanced solid tumors. It is not approved for any indication.

What does AGEN1777 target?

AGEN1777 targets TIGIT, a protein receptor. By binding to TIGIT, the small molecule is designed to act on this immune checkpoint target in advanced cancer. TIGIT is a protein target being explored in oncology drug development.

Who is developing AGEN1777?

AGEN1777 is being developed by Agenus Inc., which trades under the ticker AGEN. The company is the sponsor of the clinical program evaluating this small molecule in advanced cancer.

What phase is AGEN1777 in?

AGEN1777 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA. The Phase 1 program has included one completed trial in participants with advanced solid tumors.

What clinical trials is AGEN1777 in?

AGEN1777 has been studied in one Phase 1 trial, NCT05025085, titled A Study Investigating AGEN1777 in Participants With Advanced Solid Tumors. The trial enrolled 25 participants in the United States, was controlled and randomized, and is now completed.