A Study Investigating AGEN1777 in Participants With Advanced Solid Tumors

NCT ID: NCT05025085

Last Updated: 2025-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-04

Study Completion Date

2024-04-01

Brief Summary

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This study is a multicenter, Phase 1 study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of AGEN1777 as a single agent and when used in combination with a PD-1 inhibitor in participants with advanced, metastatic solid tumors.

Detailed Description

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Conditions

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Advanced Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Dose escalation
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Monotherapy with AGEN1777

3+3 Dose escalation of AGEN1777 will be administered by Intravenous (IV) infusion every 3 weeks (each cycle is 21 days \[3 weeks\]).

Group Type EXPERIMENTAL

AGEN1777

Intervention Type DRUG

An immunoglobulin gamma (IgG1) antibody

AGEN1777 in combination with a PD-1 inhibitor

3+3 Dose escalation of AGEN1777 in combination with a PD-1 inhibitor will be administered by IV infusion with specified dose on specified days.

Group Type EXPERIMENTAL

AGEN1777

Intervention Type DRUG

An immunoglobulin gamma (IgG1) antibody

a PD-1 inhibitor

Intervention Type DRUG

Anti-programmed cell death protein 1 (Anti-PD-1) antibody monoclonal antibody

Interventions

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AGEN1777

An immunoglobulin gamma (IgG1) antibody

Intervention Type DRUG

a PD-1 inhibitor

Anti-programmed cell death protein 1 (Anti-PD-1) antibody monoclonal antibody

Intervention Type DRUG

Eligibility Criteria

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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 Criteria in Solid Tumors version 1.1 (RECIST 1.1).
3. Life expectancy of at least 3 months and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria

1. Active infection requiring treatment.
2. Lack of recovery for participants who had major surgical procedure within 4 weeks prior to first dose of protocol therapy.
3. Clinically significant cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥ II), or serious uncontrolled cardiac arrhythmia requiring medication.
4. Corrected QT interval (QTc) (corrected for heart rate using Fridericia's formula prolongation) \>480 msec at screening except for right bundle branch block.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agenus Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 165

Grand Rapids, Michigan, United States

Site Status

START Midwest

Grand Rapids, Michigan, United States

Site Status

Local Institution - 024

Southfield, Michigan, United States

Site Status

Local Institution - 072

Cincinnati, Ohio, United States

Site Status

University of Cincinnati Cancer Center

Cincinnati, Ohio, United States

Site Status

Providence Cancer Institute

Portland, Oregon, United States

Site Status

Lifespan Cancer Institute

Providence, Rhode Island, United States

Site Status

Local Institution - 0001

Providence, Rhode Island, United States

Site Status

Local Institution - 164

Dallas, Texas, United States

Site Status

Mary Crowley Cancer Research

Dallas, Texas, United States

Site Status

MD Anderson Cancer Center Thoracic-Head & Neck Med Onc

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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C-1400-01

Identifier Type: OTHER

Identifier Source: secondary_id

CA115-P01

Identifier Type: -

Identifier Source: org_study_id

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