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Monoclonal Antibodies
Fc-Engineered Anti-CTLA-4 Monoclonal Antibody for Advanced 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
Adequate organ and bone marrow reserve function as indicated by specific laboratory values.
Provision of signed and dated written informed consent prior to any study specific procedures. Participation in pharmacogenomics testing is optional.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose to first observation of documented disease progression (or death within 12 weeks of last tumor assessment) (up to 2 years)
Awards & highlights
Study Summary
This trial is testing the safety of a new immunotherapy drug for people with solid tumors. The drug will be given alone and in combination with another immunotherapy drug to see what the maximum tolerated dose is.
Who is the study for?
This trial is for adults with certain advanced cancers, like colorectal or ovarian cancer, who have no standard treatment options left or those that failed. They must expect to live at least 3 more months, be relatively active and healthy enough for daily life (ECOG status of 0-1), have proper organ function, not be pregnant, agree to use contraception, and provide a recent tumor tissue sample.Check my eligibility
What is being tested?
The study tests botensilimab alone and combined with balstilimab in patients with advanced solid tumors. It's an early-phase trial aiming to find the safest dose levels (MTD) and the recommended doses for future studies (RP2D). The effects on the body are closely monitored through lab tests.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as inflammation in different parts of the body, infusion-related reactions which can occur during or after drug administration, fatigue, possible liver issues due to altered enzyme levels, skin rash or itching.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood tests show my organs and bone marrow are working well.
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I have signed the consent form for this study.
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I have a specific type of cancer like Angiosarcoma, HCC, NSCLC, Prostate, or Breast Cancer.
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I have a recent tumor tissue sample not from an irradiated area.
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My cancer is advanced, and standard treatments haven't worked or aren't available.
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My cancer can be measured on scans, except if it's prostate cancer.
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I am a woman who can have children, not pregnant, and willing to use effective birth control.
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I am expected to live more than 3 months and can care for myself with minimal assistance.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first dose to first observation of documented disease progression (or death within 12 weeks of last tumor assessment) (up to 2 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose to first observation of documented disease progression (or death within 12 weeks of last tumor assessment) (up to 2 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
DLT Of Botensilimab
Incidence Of Treatment-emergent Adverse Events (TEAEs)
RP2D Of Botensilimab
Secondary outcome measures
Anti-drug Antibodies (ADAs)
Area Under The Drug Concentration-time Curve From Time Zero To Infinity [AUC(0-∞)]
Area Under The Drug Concentration-time Curve Within Time Span t1 To t2 At Steady-state (AUC(t1-t2)-ss)
+15 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: 6-Week MonotherapyExperimental Treatment1 Intervention
3+3 Dose escalation: botensilimab, every 6 weeks, starting at dose level 1 mg/kg up to 4 mg/kg, administered IV for up to 2 years.
Group II: 6-Week Combination TherapyExperimental Treatment2 Interventions
3+3 Dose escalation: balstilimab, every 2 weeks, at dose level 3 mg/kg in combination with botensilimab, every 6 weeks, starting at dose level 0.1 mg/kg up to 4 mg/kg, administered IV for up to 2 years. Participants enrolled at sites in the United Kingdom (UK) may have the option for extended treatment. An additional cohort will investigate balstilimab, every 3 weeks, at 450 mg in combination with botensilimab every 6 weeks, at 150 mg, administered IV for up to 2 years.
Group III: 3-Week MonotherapyExperimental Treatment1 Intervention
3+3 Dose escalation: botensilimab, every 3 weeks, starting at dose level 0.1 milligrams/kilogram (mg/kg) up to 4 mg/kg, administered intravenously (IV) for up to 2 years.
Find a Location
Who is running the clinical trial?
Agenus Inc.Lead Sponsor
51 Previous Clinical Trials
4,237 Total Patients Enrolled
Medical DirectorStudy DirectorAgenus Inc.
2,777 Previous Clinical Trials
8,062,934 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood tests show my organs and bone marrow are working well.I have signed the consent form for this study.I have a specific type of cancer like Angiosarcoma, HCC, NSCLC, Prostate, or Breast Cancer.I do not have a psychiatric condition, substance abuse issue, or another cancer that would affect my study participation. I am not pregnant or breastfeeding.I have had chemotherapy, biological therapy, radiation, or major surgery recently.I haven't needed systemic treatment for an autoimmune disease, had an organ transplant, or had significant infections or heart disease recently.I have a recent tumor tissue sample not from an irradiated area.My cancer is advanced, and standard treatments haven't worked or aren't available.I have not been in a clinical trial for a new treatment or device within the last 3 weeks.My cancer can be measured on scans, except if it's prostate cancer.I am a woman who can have children, not pregnant, and willing to use effective birth control.I have had severe allergic reactions to certain medications or have specific lung or immune conditions.I am expected to live more than 3 months and can care for myself with minimal assistance.
Research Study Groups:
This trial has the following groups:- Group 1: 6-Week Combination Therapy
- Group 2: 6-Week Monotherapy
- Group 3: 3-Week Monotherapy
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.
What are the geographical locations at which this research is being conducted?
"Various medical centres across the US are enrolling patients for this trial, such as John Wayne Cancer Institute in Santa Monica and The University of Texas Health Science Centre at San Antonio. Moreover, there are an additional 14 sites participating in this clinical investigation, including HonorHealth Research Institute located in Scottsdale."
Answered by AI
Is this study an innovative exploration of a particular topic?
"The first trials for AGEN1181, sponsored by Agenus Inc., started in 2019 and included 195 participants. Following the initial study, Phase 1 drug approval was granted to this medication. Currently there are 6 studies being conducted globally across 95 cities within 8 countries."
Answered by AI
Has AGEN1181 attained official recognition from the FDA?
"AGEN1181's safety was given a score of 1 due to lack of clinical data supporting its efficacy and limited evidence evaluating its potential risks."
Answered by AI
Is there any prior research surrounding AGEN1181?
"AGEN1181's initial clinical research was conducted in 2019 at Columbia University Irving Medical Center. This medication has since undergone 2 completed trials, with 6 more currently active sites - most notably in Santa Monica, California."
Answered by AI
Is there still availability for individuals to participate in this scientific experiment?
"As recorded on clinicaltrials.gov, this medical study is presently in the recruitment phase and has been since April 1st 2019 when it was first posted. The listing was last updated on September 15th 2022."
Answered by AI
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