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Monoclonal Antibodies

AGEN1571 + Immunotherapy for 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
Eastern Cooperative Oncology Group performance status of 0 or 1
Histologically confirmed diagnosis of a solid tumor that is currently metastatic or locally advanced for which no standard therapy is available or standard therapy has failed
Screening 3 weeks
Treatment Varies
Follow Up day 1 up to 90 days after the last dose
Awards & highlights

Study Summary

This trial is testing a new drug (AGEN1571) to see if it is safe and effective when used alone or in combination with other drugs (balstilimab and/or botensilimab) to treat advanced solid tumors. The trial will be conducted in two parts: (1) a dose escalation phase to determine the recommended phase 2 dose (RP2D) of AGEN1571 and (2) a dose expansion phase to evaluate safety and efficacy in specific disease indications.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking normal cells by mistake (autoimmune reactions), infusion-related symptoms like fever or chills during drug administration, fatigue, liver problems due to medication processing demands on the body's detox systems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I am fully active or can carry out light work.
My cancer is advanced or has spread, and standard treatments have failed or are not available.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 up to 90 days after the last dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 up to 90 days after the last dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number Of Participants With Dose-limiting Toxicities
Number Of Participants With Treatment-emergent Adverse Events
Secondary outcome measures
Complete Response (CR) Rate
Disease Control Rate (DCR)
Duration Of Response (DOR)
+7 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Dose ExpansionExperimental Treatment3 Interventions
AGEN1571 administered at the RP2D for monotherapy or any combination therapy.
Group II: Dose Escalation: AGEN1571 + BotensilimabExperimental Treatment2 Interventions
Participants will receive AGEN1571 with botensilimab.
Group III: Dose Escalation: AGEN1571 + Balstilimab + BotensilimabExperimental Treatment3 Interventions
Participants will receive AGEN1571 with balstilimab and botensilimab.
Group IV: Dose Escalation: AGEN1571 + BalstilimabExperimental Treatment2 Interventions
Participants will receive AGEN1571 with balstilimab.
Group V: Dose Escalation: AGEN1571Experimental Treatment1 Intervention
Participants will receive AGEN1571 monotherapy.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but also affects normal cells, leading to side effects. Targeted therapy involves drugs designed to target specific molecules involved in cancer growth and spread, such as HER2 or EGFR, offering more precise treatment with potentially fewer side effects. Immunotherapy, including PD-1 inhibitors like balstilimab, enhances the body's immune system to recognize and attack cancer cells. Understanding these mechanisms helps patients and doctors choose the most effective treatment with the best balance of efficacy and side effects, tailored to the specific characteristics of the tumor.
Emerging therapies in castration resistant prostate cancer.Promising novel therapies for the treatment of endometrial cancer.

Find a Location

Who is running the clinical trial?

Agenus Inc.Lead Sponsor
52 Previous Clinical Trials
4,767 Total Patients Enrolled

Media Library

AGEN1571 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05377528 — Phase 1
Solid Tumors Research Study Groups: Dose Escalation: AGEN1571 + Botensilimab, Dose Escalation: AGEN1571 + Balstilimab + Botensilimab, Dose Escalation: AGEN1571, Dose Escalation: AGEN1571 + Balstilimab, Dose Expansion
Solid Tumors Clinical Trial 2023: AGEN1571 Highlights & Side Effects. Trial Name: NCT05377528 — Phase 1
AGEN1571 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05377528 — Phase 1
~12 spots leftby Jan 2027