AGEN1571 + Immunotherapy for Cancer

Recruiting at 6 trial locations

Overseen By Agenus, Inc. Clinical Trial Information

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Agenus Inc.

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Active CNS metastases, Autoimmune disease, Cardiovascular disease, others

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

Compensation: Varies

Number of Visits: Unknown

22 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called AGEN1571 alone and with two other drugs in patients with advanced solid tumors. The goal is to find safe doses and see how well the drugs work. The drugs aim to either directly attack cancer cells or help the immune system fight them.

Eligibility Criteria

This trial is for adults with advanced solid tumors that have spread or are inoperable, and no standard treatments work or exist. They must be relatively healthy otherwise, with a life expectancy of at least 3 months and good organ function. Women who can have children and men with partners who can conceive must use effective birth control. People cannot join if they've had certain severe reactions to similar drugs, recent other treatments, active infections including HIV/HBV/HCV, significant heart issues, or uncontrolled high blood pressure.

Inclusion Criteria

I am a man and will use birth control as required if my partner can have children.

I had cancer before, but it meets the trial's specific conditions.

Life expectancy of at least 3 months

Exclusion Criteria

Currently participating in another study involving investigational agents or received study therapy within 3 weeks of first dose of current study drug

I haven't needed systemic treatment for an autoimmune disease in the last 2 years.

Pregnant or breastfeeding

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive AGEN1571 as monotherapy or in combination with balstilimab and/or botensilimab to determine the recommended phase 2 dose (RP2D)

Up to 2 years

Dose Expansion

Participants receive AGEN1571 at the RP2D for specific disease indications

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

• AGEN1571
• Balstilimab
• Botensilimab

Trial Overview The study tests AGEN1571 alone and combined with balstilimab/botensilimab in two parts: first finding the right doses (dose escalation), then seeing how well these work on specific tumor types (dose expansion). Participants will receive treatment up to two years unless their disease worsens or side effects become too much.

Participant Groups

Group I: Dose Expansion Experimental Treatment 3 Interventions

AGEN1571 administered at the RP2D for monotherapy or any combination therapy.

Group II: Dose Escalation: AGEN1571 + Botensilimab Experimental Treatment 2 Interventions

Participants will receive AGEN1571 with botensilimab.

Group III: Dose Escalation: AGEN1571 + Balstilimab + Botensilimab Experimental Treatment 3 Interventions

Participants will receive AGEN1571 with balstilimab and botensilimab.

Group IV: Dose Escalation: AGEN1571 + Balstilimab Experimental Treatment 2 Interventions

Participants will receive AGEN1571 with balstilimab.

Group V: Dose Escalation: AGEN1571 Experimental Treatment 1 Intervention

Participants will receive AGEN1571 monotherapy.

Who Is Running the Clinical Trial?

Agenus Inc.

Lead Sponsor

Trials

58

Recruited

4,900+