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Monoclonal Antibodies

AGEN1777 + PD-1 Inhibitor for Cancer

Phase 1
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Life expectancy of at least 3 months and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 1 of cycle 1 (each cycle is 21 days [3 weeks]) until every 9 weeks (±7 days) for 12 months, and every 12 weeks (±7 days) thereafter up to 2 years or until progressive disease or unacceptable toxicity
Awards & highlights

Study Summary

This trial is testing a new drug, AGEN1777, to see if it is safe and effective when used alone or with a different drug, a PD-1 inhibitor, to treat advanced solid tumors.

Who is the study for?
This trial is for adults with advanced solid tumors that have no standard treatment options left or didn't respond to previous treatments. Participants must have a life expectancy of at least 3 months, be relatively active and well (ECOG status 0 or 1), and their disease must be measurable on scans.Check my eligibility
What is being tested?
The study tests AGEN1777 alone and combined with a PD-1 inhibitor in patients with advanced cancer. It aims to assess the safety, how the body processes it (pharmacokinetics), and its effects on the body's response to disease (pharmacodynamics).See study design
What are the potential side effects?
Potential side effects may include typical reactions seen with immune therapies such as fatigue, skin reactions, inflammation in organs like lungs or intestines, flu-like symptoms, changes in blood pressure or heart rhythm.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is advanced, and standard treatments have failed or are not suitable.
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I am expected to live at least 3 more months and can care for myself with minimal assistance.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 of cycle 1 (each cycle is 21 days [3 weeks]) until every 9 weeks (±7 days) for 12 months, and every 12 weeks (±7 days) thereafter up to 2 years or until progressive disease or unacceptable toxicity
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 of cycle 1 (each cycle is 21 days [3 weeks]) until every 9 weeks (±7 days) for 12 months, and every 12 weeks (±7 days) thereafter up to 2 years or until progressive disease or unacceptable toxicity for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Number of Participants with Dose-Limiting Toxicities (DLT) of AGEN1777 as a Single-Agent and in Combination with a PD-1 inhibitor
Secondary outcome measures
Complete Response (CR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) Based on Investigator's assessment
Duration of Response (DOR) per RECIST v1.1 Based on Investigator's Assessment
Maximum Observed Concentration at Steady State (Cmax-ss) of Serum AGEN1777 and a PD-1 inhibitor
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Monotherapy with AGEN1777Experimental Treatment1 Intervention
3+3 Dose escalation of AGEN1777 will be administered by Intravenous (IV) infusion every 3 weeks (each cycle is 21 days [3 weeks]).
Group II: AGEN1777 in combination with a PD-1 inhibitorExperimental Treatment2 Interventions
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.

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,629 Previous Clinical Trials
4,126,461 Total Patients Enrolled
Agenus Inc.Industry Sponsor
49 Previous Clinical Trials
4,891 Total Patients Enrolled
Medical DirectorStudy DirectorAgenus Inc.
2,769 Previous Clinical Trials
8,062,125 Total Patients Enrolled

Media Library

AGEN1777 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05025085 — Phase 1
Cancer Research Study Groups: Monotherapy with AGEN1777, AGEN1777 in combination with a PD-1 inhibitor
Cancer Clinical Trial 2023: AGEN1777 Highlights & Side Effects. Trial Name: NCT05025085 — Phase 1
AGEN1777 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05025085 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the research team currently seeking volunteers to participate in this exploration?

"Affirmative. Clinicaltrials.gov data suggests that recruitment for this research study is still ongoing, with the first posting on October 4th 2021 and most recent update on September 13th 2022. 75 individuals are being sought from 6 different sites to participate in the trial."

Answered by AI

How many locations are engaged in this research endeavor?

"This study is ongoing in 6 different medical centres, including the University of Cincinnati Cancer Center, Mary Crowley Cancer Research and Providence Cancer Institute. Additionally there are other 3 sites offering this treatment."

Answered by AI

Could you describe what safety risks might come with a prescription of PD-1 inhibitor?

"As this is a Phase 1 trial and there are limited results indicating the efficacy and safety of PD-1 inhibitors, it has been assigned a score of 1."

Answered by AI

How many individuals will the trial accommodate?

"Agenus Inc. is the sponsor for this clinical trial, and they hope to recruit 75 eligible patients from multiple sites such as University of Cincinnati Cancer Center in Cincinnati, Ohio or Mary Crowley Cancer Research in Dallas, Texas."

Answered by AI
~22 spots leftby Mar 2025