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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.
Sufficient and adequate formalin-fixed paraffin embedded tumor tissue sample collected since last treatment and before the first dose from a site not previously irradiated, if clinically feasible.
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upfrom first dose to first observation of documented disease progression (or death within 12 weeks of last tumor assessment) (up to 2 years)
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Ovarian Cancer
- Colorectal Cancer
- Cancer
- Hemangiosarcoma
- Endometrial Cancer
- Fibrolamellar Carcinoma
- Non-Small Cell Lung Cancer
- Prostate Cancer
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
Your organs and bone marrow are working well, as shown by specific lab tests.
Select...
There is enough tumor tissue collected before the first dose of the study drug for testing.
Select...
You have a type of cancer that has spread or is very advanced, and there are no standard treatments available or the standard treatments have not worked.
Select...
You need to have a detectable disease on imaging, except if you have prostate cancer.
Select...
This is a requirement for specific groups of people with certain types of cancer such as angiosarcoma, hepatocellular cancer, non-small cell lung cancer, prostate cancer, and breast cancer.
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial 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
46 Previous Clinical Trials
4,285 Total Patients Enrolled
Medical DirectorStudy DirectorAgenus Inc.
2,736 Previous Clinical Trials
8,053,034 Total Patients Enrolled
12 Trials studying Ovarian Cancer
3,122 Patients Enrolled for Ovarian Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your organs and bone marrow are working well, as shown by specific lab tests.There is enough tumor tissue collected before the first dose of the study drug for testing.You have a history of severe allergic reactions to a specific type of medication or have certain lung or immune system conditions.You have an ongoing autoimmune disease needing treatment, had a tissue or organ transplant, a current infection needing treatment, HIV, hepatitis B or C, or significant heart problems.You have a mental health or substance abuse issue that may make it hard for you to follow the study's rules, you are not able to make legal decisions for yourself, you are pregnant or breastfeeding, or you have had cancer in the past 2 years.You have a type of cancer that has spread or is very advanced, and there are no standard treatments available or the standard treatments have not worked.You need to have a detectable disease on imaging, except if you have prostate cancer.This is a requirement for specific groups of people with certain types of cancer such as angiosarcoma, hepatocellular cancer, non-small cell lung cancer, prostate cancer, and breast cancer.
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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