Monoclonal Antibodies

AGEN1571 for Solid Tumors

Dana Farber Cancer Institute, Boston, MA
AGEN1571 +2 morePhase 1RecruitingResearch Sponsored by Agenus Inc.

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.

Eligible Conditions
  • Advanced Solid Tumors

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You are expected to live for at least three more months.


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

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: 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.

Find a site

Who is running the clinical trial?

Agenus Inc.Lead Sponsor
43 Previous Clinical Trials
4,570 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 + Balstilimab + Botensilimab, Dose Escalation: AGEN1571 + 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has AGEN1571 received authorization from the Federal Drug Administration?

"Limited clinical data exists to support the efficacy and safety of AGEN1571 so it was assigned a score of 1."

Answered by AI

Are there still opportunities to partake in this scientific exploration?

"As articulated on, this experiment is presently seeking out subjects to participate. This project was uploaded onto the database on July 19th 2022 and has since undergone a few modifications as of July 21st 2022."

Answered by AI

To what extent is this research being conducted in North America?

"The 8 participating sites for this clinical trial are located in Florida Cancer Specialists (Sarasota, FL), Lifespan Cancer Institute (Providence, RI), USC Norris Comprehensive Cancer Center (Los Angeles, CA) and 6 other medical centres."

Answered by AI

To what extent is this research being conducted with participants?

"To successfully execute this trial, 98 volunteers that meet the necessary criteria must be found. Agenus Inc., who is serving as the sponsor of this medical study, will be recruiting these participants from two sites in Florida and Rhode Island respectively."

Answered by AI
~65 spots leftby Jan 2027