AGEN1571 for Solid Tumors, Advanced Solid Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Texas Oncology - Charles A. Sammons Cancer Center, Dallas, TX
Solid Tumors, Advanced Solid Tumors+1 More
AGEN1571 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is an open-label, Phase 1, 2-part study to determine the recommended phase 2 dose (RP2D) and evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic profiles of AGEN1571 both as a monotherapy and in combination with balstilimab and/or botensilimab (2-agent combination or 3-agent combination) in participants diagnosed with advanced solid tumors. Part 1 will be the dose escalation phase to determine the RP2D of AGEN1571 monotherapy or AGEN1571 in combination with balstilimab and/or botensilimab. Part 2 will be the dose expansion phase for specific disease indications. Participants will receive study treatment for up to 2 years, or until any disease progression, unacceptable toxicity, or participant wishes to withdraw consent for any reason.

Eligible Conditions

  • Solid Tumors, Advanced Solid Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Solid Tumors, Advanced Solid Tumors

Study Objectives

2 Primary · 8 Secondary · Reporting Duration: Day 1 up to 90 days after the last dose

Day 42
Number Of Participants With Dose-limiting Toxicities
Month 12
Number Of Participants With Treatment-emergent Adverse Events
Day 90
Complete Response
Duration Of Response
Number Of Participants With Anti-drug Antibodies
Partial Response
Serum AGEN1571 Concentration
Serum Balstilimab Concentration
Serum Botensilimab Concentration
Stable Disease

Trial Safety

Safety Progress

1 of 3

Other trials for Solid Tumors, Advanced Solid Tumors

Trial Design

5 Treatment Groups

Dose Escalation: AGEN1571 + Balstilimab + Botensilimab
1 of 5
Dose Escalation: AGEN1571 + Botensilimab
1 of 5
Dose Escalation: AGEN1571 + Balstilimab
1 of 5
Dose Expansion
1 of 5
Dose Escalation: AGEN1571
1 of 5
Experimental Treatment

98 Total Participants · 5 Treatment Groups

Primary Treatment: AGEN1571 · No Placebo Group · Phase 1

Dose Escalation: AGEN1571 + Balstilimab + BotensilimabExperimental Group · 3 Interventions: AGEN1571, Botensilimab, Balstilimab · Intervention Types: Drug, Drug, Drug
Dose Escalation: AGEN1571 + BotensilimabExperimental Group · 2 Interventions: AGEN1571, Botensilimab · Intervention Types: Drug, Drug
Dose Escalation: AGEN1571 + BalstilimabExperimental Group · 2 Interventions: AGEN1571, Balstilimab · Intervention Types: Drug, Drug
Dose ExpansionExperimental Group · 3 Interventions: AGEN1571, Botensilimab, Balstilimab · Intervention Types: Drug, Drug, Drug
Dose Escalation: AGEN1571
Drug
Experimental Group · 1 Intervention: AGEN1571 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 up to 90 days after the last dose
Closest Location: Texas Oncology - Charles A. Sammons Cancer Center · Dallas, TX
Photo of Dallas 1Photo of Dallas 2Photo of Dallas 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Solid Tumors, Advanced Solid Tumors
0 CompletedClinical Trials

Who is running the clinical trial?

Agenus Inc.Lead Sponsor
34 Previous Clinical Trials
3,691 Total Patients Enrolled
1 Trials studying Solid Tumors, Advanced Solid Tumors
19 Patients Enrolled for Solid Tumors, Advanced Solid Tumors

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a solid tumor that is currently metastatic or locally advanced for which no standard therapy is available or standard therapy has failed.
You have measurable disease on baseline imaging based on RECIST 1.1.
You have an absolute neutrophil count ≥1.5 × 10^9/L, a platelet count ≥100 × 10^9/L, and a hemoglobin ≥8 g/dL without recent transfusion.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.