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Monoclonal Antibodies

Anti-CD137 + Anti-CTLA-4 Monoclonal Antibodies for Advanced Cancer

Phase 1
Waitlist Available
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 the following laboratory values: Adequate hematological function, defined as absolute neutrophil count ≥ 1.5 × 10^9/L, platelet count ≥ 100 × 10^9/L, and hemoglobin ≥ 8 g/dL without recent transfusion (defined as a transfusion that has occurred within 2 weeks of the hemoglobin measurement); Adequate liver function, defined as total bilirubin level ≤ 1.5 × upper limit of normal (ULN), aspartate aminotransferase ≤ 2.5 × ULN, and alanine aminotransferase ≤ 2.5 × ULN, albumin ≥ 3 g/dL, and alkaline phosphatase ≤ 2.5 × ULN or ≤ 5 × ULN for patients with liver metastases; Adequate renal function defined as creatinine ≤ 1.5 × ULN OR measured or calculated creatinine clearance ≥ 40 mL/minute per institutional standard. Assessment methods should be recorded; Adequate coagulation, defined as international normalized ratio or prothrombin time ≤ 1.5 × ULN and activated partial thromboplastin time ≤ 1.5 × ULN (unless patient is receiving anticoagulant therapy)
Specific Melanoma Criteria: Inclusion: Histological confirmation of cutaneous melanoma; Progression on or within 24 weeks of stopping treatment with a PD-1/PD-L1 confirmed per Society for Immunotherapy of Cancer (SITC); Patients with BRAF V600-positive tumor(s) should also have received prior treatment with a BRAF inhibitor (alone or in combination with a MEK inhibitor) or have declined targeted therapy. Note: Patients with BRAF V600-positive tumors with no clinically significant tumor-related symptoms nor evidence of rapidly progressive disease are not required to be treated with a BRAF inhibitor (alone or in combination with a MEK inhibitor) based on Investigator's decision.
Must not have
Has had an allogeneic tissue/solid organ transplant except for corneal transplantation.
Legally incapacitated or has limited legal capacity.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up evaluated throughout the protocol up to 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new cancer drug to see if it is safe and effective. The drug will be given to people with advanced solid tumors.

Who is the study for?
Adults with advanced solid tumors that have spread or are inoperable, and who've had no success with standard treatments. They must be healthy enough overall, not pregnant, willing to use contraception, and able to provide a recent tumor tissue sample. People can't join if they've recently received certain vaccines or treatments, have severe allergies to human antibodies, uncontrolled health issues like heart disease or infections, mental incapacity, or are pregnant.
What is being tested?
The trial is testing AGEN2373 alone and combined with botensilimab for safety and effectiveness in treating cancer. It's an early-phase study (Phase 1) where doctors will find the highest dose patients can take without serious side effects by gradually increasing doses for new groups of patients.
What are the potential side effects?
Possible side effects include reactions related to the immune system since both drugs target proteins that control immune responses. This could lead to inflammation in different parts of the body. The exact side effects aren't listed but typically include symptoms like fatigue, fever, skin reactions among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had cancer before, but I finished treatment over 2 years ago and am now cancer-free.
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My kidney function is within the required range.
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My blood counts meet the required levels without recent transfusions.
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I am expected to live more than 3 months and can care for myself with minimal assistance.
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My cancer is advanced or has spread, and standard treatments have failed or are not available.
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I can provide a recent tumor sample not from an irradiated area and agree to a biopsy during the study if needed.
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My liver is functioning well according to recent tests.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a transplant of tissue or an organ from another person, except for a cornea transplant.
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I am not legally allowed to make my own decisions.
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I do not have serious heart conditions or recent major heart or stroke events.
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I have not had recent cancer treatments outside the allowed time before starting the study drug.
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I am currently being treated for an infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~evaluated throughout the protocol up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and evaluated throughout the protocol up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Therapeutic procedure
Frequency of treatment-emergent adverse events (TEAEs)
Occurrence of Dose Limiting Toxicity (DLT)
+1 more
Secondary study objectives
Area under the plasma/serum concentration-time curve from time zero to infinity (AUC(0-∞))
Serum
Area under the plasma/serum concentration-time curve within time span t1 to t2 at steady-state (AUC(t1-t2)-ss)
+12 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups
Experimental Treatment
Group I: Combination Therapy with 3-week AGEN2373 in combination with 6-week BotensilimabExperimental Treatment2 Interventions
3+3+3 Dose escalation of AGEN2373. AGEN2373 and botensilimab administered by IV.
Group II: Combination Therapy with 3-week AGEN2373 Monotherapy Lead-In Combination with 6-week BotensilimabExperimental Treatment2 Interventions
3+3+3 Dose escalation of AGEN2373. AGEN2373 and botensilimab administered by IV.
Group III: 4-Week Monotherapy with AGEN2373Experimental Treatment1 Intervention
3+3 Dose escalation of AGEN2373 administered by IV.
Group IV: 3-Week Monotherapy with AGEN2373Experimental Treatment1 Intervention
3+3 Dose escalation of AGEN2373 administered by IV.
Group V: 2-Week Monotherapy with AGEN2373Experimental Treatment1 Intervention
3+3 Dose escalation of AGEN2373 administered by IV.

Find a Location

Who is running the clinical trial?

Agenus Inc.Lead Sponsor
52 Previous Clinical Trials
4,749 Total Patients Enrolled
Medical DirectorStudy DirectorAgenus Inc.
2,905 Previous Clinical Trials
8,091,422 Total Patients Enrolled
Medical MonitorStudy DirectorAgenus Inc.
1,678 Previous Clinical Trials
990,031 Total Patients Enrolled

Media Library

AGEN1181 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04121676 — Phase 1
Cancer Research Study Groups: Combination Therapy with 3-week AGEN2373 in combination with 6-week Botensilimab, Combination Therapy with 3-week AGEN2373 Monotherapy Lead-In Combination with 6-week Botensilimab, 3-Week Monotherapy with AGEN2373, 4-Week Monotherapy with AGEN2373, 2-Week Monotherapy with AGEN2373
Cancer Clinical Trial 2023: AGEN1181 Highlights & Side Effects. Trial Name: NCT04121676 — Phase 1
AGEN1181 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04121676 — Phase 1
~4 spots leftby Jun 2025
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