22 Participants Needed

AGEN1571 + Immunotherapy for Cancer

Recruiting at 6 trial locations
AI
Overseen ByAgenus, Inc. Clinical Trial Information
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

Are You a Good Fit for This Trial?

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
See 8 more

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
See 15 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
5Treatment groups
Experimental Treatment
Group I: Dose ExpansionExperimental Treatment3 Interventions
Group II: Dose Escalation: AGEN1571 + BotensilimabExperimental Treatment2 Interventions
Group III: Dose Escalation: AGEN1571 + Balstilimab + BotensilimabExperimental Treatment3 Interventions
Group IV: Dose Escalation: AGEN1571 + BalstilimabExperimental Treatment2 Interventions
Group V: Dose Escalation: AGEN1571Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Agenus Inc.

Lead Sponsor

Trials
58
Recruited
4,900+
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