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Monoclonal Antibodies
AGEN1571 + Immunotherapy for Cancer
Phase 1
Recruiting
Research Sponsored by Agenus Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group performance status of 0 or 1
Histologically confirmed diagnosis of a solid tumor that is currently metastatic or locally advanced for which no standard therapy is available or standard therapy has failed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 up to 90 days after the last dose
Awards & highlights
Study Summary
This trial is testing a new drug (AGEN1571) to see if it is safe and effective when used alone or in combination with other drugs (balstilimab and/or botensilimab) to treat advanced solid tumors. The trial will be conducted in two parts: (1) a dose escalation phase to determine the recommended phase 2 dose (RP2D) of AGEN1571 and (2) a dose expansion phase to evaluate safety and efficacy in specific disease indications.
Who is the study for?
This trial is for adults with advanced solid tumors that have spread or are inoperable, and no standard treatments work or exist. They must be relatively healthy otherwise, with a life expectancy of at least 3 months and good organ function. Women who can have children and men with partners who can conceive must use effective birth control. People cannot join if they've had certain severe reactions to similar drugs, recent other treatments, active infections including HIV/HBV/HCV, significant heart issues, or uncontrolled high blood pressure.Check my eligibility
What is being tested?
The study tests AGEN1571 alone and combined with balstilimab/botensilimab in two parts: first finding the right doses (dose escalation), then seeing how well these work on specific tumor types (dose expansion). Participants will receive treatment up to two years unless their disease worsens or side effects become too much.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking normal cells by mistake (autoimmune reactions), infusion-related symptoms like fever or chills during drug administration, fatigue, liver problems due to medication processing demands on the body's detox systems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
Select...
My cancer is advanced or has spread, and standard treatments have failed or are not available.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 up to 90 days after the last dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 up to 90 days after the last dose
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 Dose-limiting Toxicities
Number Of Participants With Treatment-emergent Adverse Events
Secondary outcome measures
Complete Response (CR) Rate
Disease Control Rate (DCR)
Duration Of Response (DOR)
+7 moreTrial Design
5Treatment groups
Experimental Treatment
Group I: Dose ExpansionExperimental Treatment3 Interventions
AGEN1571 administered at the RP2D for monotherapy or any combination therapy.
Group II: Dose Escalation: AGEN1571 + BotensilimabExperimental Treatment2 Interventions
Participants will receive AGEN1571 with botensilimab.
Group III: Dose Escalation: AGEN1571 + Balstilimab + BotensilimabExperimental Treatment3 Interventions
Participants will receive AGEN1571 with balstilimab and botensilimab.
Group IV: Dose Escalation: AGEN1571 + BalstilimabExperimental Treatment2 Interventions
Participants will receive AGEN1571 with balstilimab.
Group V: Dose Escalation: AGEN1571Experimental Treatment1 Intervention
Participants will receive AGEN1571 monotherapy.
Find a Location
Who is running the clinical trial?
Agenus Inc.Lead Sponsor
51 Previous Clinical Trials
4,689 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a man and will use birth control as required if my partner can have children.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I had cancer before, but it meets the trial's specific conditions.I have not had brain radiation in the last 2 weeks.I have lasting side effects from previous treatments that are moderate or worse.My high blood pressure is not well-controlled, or I take more than 3 medications for it.I am on steroids or immunosuppressants for a health condition.I am legally not allowed or limited in making my own decisions.I am HIV positive or have active hepatitis B or C.I have had a transplant, but it was not a corneal transplant.I can provide a tissue sample and agree to a biopsy if needed.I have not had recent chemotherapy, biological therapy, radiotherapy, or major surgery.I have a serious heart condition.I am fully active or can carry out light work.I am a woman able to have children and meet specific health criteria.I don't have any health issues that would stop me from following the trial's requirements.I have received a COVID-19 vaccine within the required time frame.My brain metastases are treated and stable.My recent blood tests show my organs and bone marrow are functioning well.I do not have an active infection or lung disease needing treatment recently.My cancer is advanced or has spread, and standard treatments have failed or are not available.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation: AGEN1571 + Botensilimab
- Group 2: Dose Escalation: AGEN1571 + Balstilimab + Botensilimab
- Group 3: Dose Escalation: AGEN1571
- Group 4: Dose Escalation: AGEN1571 + Balstilimab
- Group 5: Dose Expansion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has AGEN1571 received authorization from the Federal Drug Administration?
"Limited clinical data exists to support the efficacy and safety of AGEN1571 so it was assigned a score of 1."
Answered by AI
Are there still opportunities to partake in this scientific exploration?
"As articulated on clinicaltrials.gov, this experiment is presently seeking out subjects to participate. This project was uploaded onto the database on July 19th 2022 and has since undergone a few modifications as of July 21st 2022."
Answered by AI
To what extent is this research being conducted in North America?
"The 8 participating sites for this clinical trial are located in Florida Cancer Specialists (Sarasota, FL), Lifespan Cancer Institute (Providence, RI), USC Norris Comprehensive Cancer Center (Los Angeles, CA) and 6 other medical centres."
Answered by AI
To what extent is this research being conducted with participants?
"To successfully execute this trial, 98 volunteers that meet the necessary criteria must be found. Agenus Inc., who is serving as the sponsor of this medical study, will be recruiting these participants from two sites in Florida and Rhode island respectively."
Answered by AI
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