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

Recruiting at 15 trial locations

Overseen By Agenus, Inc. Clinical Trial Information

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Agenus Inc.

Must not be taking: Corticosteroids, Immunosuppressives

Disqualifiers: Autoimmune disease, CNS tumor, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Up to 2 years

91 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is an open-label, Phase 1, multicenter study to evaluate the safety, tolerability, PK, and PD profiles of AGEN2373 as a monotherapy and in combination with botensilimab (also known as AGEN1181), and to assess the maximum tolerated dose (MTD) in subjects with advanced solid tumors.

Research Team

Medical Monitor

Principal Investigator

Agenus Inc.

Eligibility Criteria

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.

Inclusion Criteria

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.

There is evidence of a measurable disease seen on imaging scans that doctors will use a specific system to evaluate.

I had cancer before, but I finished treatment over 2 years ago and am now cancer-free.

Exclusion Criteria

I have had a transplant of tissue or an organ from another person, except for a cornea transplant.

I am not legally allowed to make my own decisions.

I have not been in a clinical trial for a new treatment or device within the last 3 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AGEN2373 as monotherapy or in combination with botensilimab, with dose escalation to determine the maximum tolerated dose

Up to 2 years

Every 2-4 weeks depending on the treatment arm

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

Treatment Details

Interventions

• AGEN1181
• AGEN2373
• Botensilimab

Trial Overview 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.

Participant Groups

Group I: Combination Therapy with 3-week AGEN2373 in combination with 6-week Botensilimab Experimental Treatment 2 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 Botensilimab Experimental Treatment 2 Interventions

3+3+3 Dose escalation of AGEN2373. AGEN2373 and botensilimab administered by IV.

Group III: 4-Week Monotherapy with AGEN2373 Experimental Treatment 1 Intervention

3+3 Dose escalation of AGEN2373 administered by IV.

Group IV: 3-Week Monotherapy with AGEN2373 Experimental Treatment 1 Intervention

3+3 Dose escalation of AGEN2373 administered by IV.

Group V: 2-Week Monotherapy with AGEN2373 Experimental Treatment 1 Intervention

3+3 Dose escalation of AGEN2373 administered by IV.

Who Is Running the Clinical Trial?

Agenus Inc.

Lead Sponsor

Trials

58

Recruited

4,900+