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AGEN1777

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

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 5 trials (matched to "Advanced Cancer")

Frequently asked questions about AGEN1777

What is AGEN1777 used for?

AGEN1777 is an investigational small molecule being developed for the treatment of advanced cancer. It is intended for use in patients with advanced solid tumors. The drug is currently in clinical development and has not been approved by regulatory authorities.

Who makes AGEN1777?

AGEN1777 is being developed by Agenus Inc., a biopharmaceutical company. Agenus is publicly traded under the ticker symbol AGEN on the stock market. The company is conducting clinical research to evaluate the safety and efficacy of this investigational drug.

What phase is AGEN1777 in?

AGEN1777 is in Phase 1 clinical development. It has completed a Phase 1 trial, and the drug remains investigational. It is not yet approved by the FDA or other regulatory agencies, and further clinical studies may be needed to establish its safety and effectiveness.

What clinical trials is AGEN1777 in?

AGEN1777 has been studied in a Phase 1 clinical trial with the identifier NCT05025085. This trial was titled 'A Study Investigating AGEN1777 in Participants With Advanced Solid Tumors' and enrolled 25 participants in the United States. The trial has been completed.

Is AGEN1777 FDA approved?

AGEN1777 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed Phase 1 trial evaluated the drug in patients with advanced solid tumors, but the drug has not yet received marketing approval from the FDA or any other regulatory authority.