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Monoclonal Antibodies

Fc-Engineered Anti-CTLA-4 Monoclonal Antibody for Advanced Cancer

UCLA Santa Monica Hematology Oncology, Los Angeles, CA
Targeting 8 different conditionsBotensilimab +1 morePhase 1RecruitingResearch Sponsored by Agenus Inc.

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 below
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Your organs and bone marrow are working well, as shown by specific lab tests.
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There is enough tumor tissue collected before the first dose of the study drug for testing.
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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.
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You need to have a detectable disease on imaging, except if you have prostate cancer.
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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 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)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose to first observation of documented disease progression (or death within 12 weeks of last tumor assessment) (up to 2 years) for reporting.

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 more

Awards & 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

Botensilimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03860272 — Phase 1
Ovarian Cancer Research Study Groups: 6-Week Combination Therapy, 6-Week Monotherapy, 3-Week Monotherapy
Ovarian Cancer Clinical Trial 2023: Botensilimab Highlights & Side Effects. Trial Name: NCT03860272 — Phase 1
Botensilimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03860272 — Phase 1

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

How many persons are participating in this trial research?

"This clinical trial necessitates 195 participants who meet the outlined criteria. The John Wayne Cancer Institute and The University of Texas Health Science Center are both recruiting patients for this study."

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
~209 spots leftby Dec 2026