AGEN1181 for Melanoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Melanoma+7 MoreAGEN1181 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing the safety of a new immunotherapy drug for people with solid tumors. The drug will be given alone and in combination with another immunotherapy drug to see what the maximum tolerated dose is.

Eligible Conditions
  • Melanoma
  • Fibrolamellar Carcinoma
  • Colorectal Cancer Without Liver Metastases
  • Hemangiosarcoma
  • Ovarian Cancer
  • Endometrial Cancer
  • Advanced Cancer
  • Non-small-cell Lung Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

6 Primary · 28 Secondary · Reporting Duration: From first dose to first observation of documented disease progression (or death within 12 weeks of last tumor assessment) (up to 2 years)

Year 2
Response rate according to RECIST 1.1 (ORR)
Day 28
DLT Of Botensilimab
Dose Limiting Toxicity (DLT)
Day 90
RP2D Of Botensilimab
Recommended Phase 2 Dose (RP2D)
Year 2
Incidence Of Treatment-emergent Adverse Events (TEAEs)
Year 2
Objective Response Rate (ORR) According To Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
Week 12
Response rate according to RECIST 1.1 (DOR)
Month 3
Anti-drug antibody (ADA)
Maximum drug concentration at steady-state (Cmax-ss)
Minimum drug concentration at steady-state (Cmin-ss)
Systemic clearance (CL)
Terminal elimination half-life (t1/2)
Volume of distribution (Vd)
Year 2
Anti-drug Antibodies (ADAs)
Area Under The Drug Concentration-time Curve From Time Zero To Infinity [AUC(0-∞)]
Area Under The Drug Concentration-time Curve Within Time Span t1 To t2 At Steady-state (AUC(t1-t2)-ss)
Maximum Drug Concentration At Steady-state (Cmax-ss)
Minimum Drug Concentration At Steady-state (Cmin-ss)
Systemic Clearance (CL)
Terminal Elimination Half-life (t1/2)
Terminal Elimination Rate Constant (λz)
Volume Of Distribution (Vd)
Month 3
Area under the drug concentration-time curve from time zero to infinity [AUC(0-∞)]
Area under the drug concentration-time curve within time span t1 to t2 at steady-state (AUC(t1-t2)-ss)
Terminal disposition rate constant (λz)
Year 1
Overall survival time (OS)
Week 24
Disease Control Rate (DCR) According To RECIST 1.1
Response rate according to RECIST 1.1 (DCR)
Year 3
Overall Survival Time
Year 2
Progression-free Survival (PFS) According To RECIST 1.1
Week 12
Response rate according to RECIST 1.1 (PFS)
Year 2
Duration Of Response (DOR) According To RECIST 1.1
Day 90
Incidence of Adverse Events (AEs)

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

6-Week Combination Therapy
1 of 3
6-Week Monotherapy
1 of 3
3-Week Monotherapy
1 of 3

Experimental Treatment

195 Total Participants · 3 Treatment Groups

Primary Treatment: AGEN1181 · No Placebo Group · Phase 1

6-Week Combination TherapyExperimental Group · 4 Interventions: AGEN1181, AGEN2034, Balstilimab, Botensilimab · Intervention Types: Drug, Drug, Drug, Drug
6-Week MonotherapyExperimental Group · 2 Interventions: AGEN1181, Botensilimab · Intervention Types: Drug, Drug
3-Week MonotherapyExperimental Group · 2 Interventions: AGEN1181, Botensilimab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Balstilimab
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from first dose to first observation of documented disease progression (or death within 12 weeks of last tumor assessment) (up to 2 years)

Who is running the clinical trial?

Agenus Inc.Lead Sponsor
41 Previous Clinical Trials
4,116 Total Patients Enrolled
4 Trials studying Melanoma
613 Patients Enrolled for Melanoma
Medical DirectorStudy DirectorAgenus Inc.
2,639 Previous Clinical Trials
7,942,143 Total Patients Enrolled
34 Trials studying Melanoma
10,156 Patients Enrolled for Melanoma

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have metastatic or locally advanced solid tumor for which no standard therapy is available or standard therapy has failed.
You have measurable disease on imaging based on RECIST 1.1.
You have no history of prior or concomitant malignancy that requires other active treatment.