A Study Investigating AGEN1777 in Participants With Advanced Solid Tumors

Sponsor

Agenus Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05025085

Collaborator

Bristol-Myers Squibb (Industry)

Enrollment

Locations

Arms

46.9

Anticipated Duration (Months)

12.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a multicenter, Phase 1 study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of AGEN1777 as a single agent and when used in combination with a PD-1 inhibitor in participants with advanced, metastatic solid tumors.

Condition or Disease	Intervention/Treatment	Phase
Advanced Cancer	Drug: AGEN1777 Drug: a PD-1 inhibitor	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Dose escalationDose escalation

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 1 Study Investigating AGEN1777 as a Single-Agent and in Combination With a PD-1 Inhibitor in Patients With Advanced Solid Tumors

Actual Study Start Date :

Oct 4, 2021

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Monotherapy with AGEN1777 3+3 Dose escalation of AGEN1777 will be administered by Intravenous (IV) infusion every 3 weeks (each cycle is 21 days [3 weeks]).	Drug: AGEN1777 An immunoglobulin gamma (IgG1) antibody
Experimental: AGEN1777 in combination with a PD-1 inhibitor 3+3 Dose escalation of AGEN1777 in combination with a PD-1 inhibitor will be administered by IV infusion with specified dose on specified days.	Drug: AGEN1777 An immunoglobulin gamma (IgG1) antibody Drug: a PD-1 inhibitor Anti-programmed cell death protein 1 (Anti-PD-1) antibody monoclonal antibody

Arm

Intervention/Treatment

Experimental: Monotherapy with AGEN1777

3+3 Dose escalation of AGEN1777 will be administered by Intravenous (IV) infusion every 3 weeks (each cycle is 21 days [3 weeks]).

Drug: AGEN1777

An immunoglobulin gamma (IgG1) antibody

Experimental: AGEN1777 in combination with a PD-1 inhibitor

3+3 Dose escalation of AGEN1777 in combination with a PD-1 inhibitor will be administered by IV infusion with specified dose on specified days.

Drug: AGEN1777

An immunoglobulin gamma (IgG1) antibody

Drug: a PD-1 inhibitor

Anti-programmed cell death protein 1 (Anti-PD-1) antibody monoclonal antibody

Outcome Measures

Primary Outcome Measures

Number of Participants with Dose-Limiting Toxicities (DLT) of AGEN1777 as a Single-Agent and in Combination with a PD-1 inhibitor [Day 1 through Day 21]
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Up to 2 years and 90 days]

Secondary Outcome Measures

Maximum Observed Concentration at Steady State (Cmax-ss) of Serum AGEN1777 and a PD-1 inhibitor [Day 1 Up to End of Treatment (up to 2 years)]
Serum AGEN1777 Anti-Drug Antibody (ADA) Determination [Day 1 of Cycle 1 (Cycle = 21 days) through Day 1 of Cycle 5. Incidence of ADA]
Serum a PD-1 inhibitor Anti-Drug Antibody (ADA) Determination [Day 1 Up to End of Treatment (up to 2 years)]
Complete Response (CR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) Based on Investigator's assessment [From Day 1 of Cycle 1 (each cycle is 21 days [3 weeks]) until every 9 weeks (±7 days) for 12 months, and every 12 weeks (±7 days) thereafter up to 2 years or until progressive disease or unacceptable toxicity]
Partial Response (PR) per RECIST v1.1 Based on Investigator's Assessment [From Day 1 of Cycle 1 (each cycle is 21 days [3 weeks]) until every 9 weeks (±7 days) for 12 months, and every 12 weeks (±7 days) thereafter up to 2 years or until progressive disease or unacceptable toxicity]
Duration of Response (DOR) per RECIST v1.1 Based on Investigator's Assessment [From Day 1 of Cycle 1 (each cycle is 21 days [3 weeks]) until every 9 weeks (±7 days) for 12 months, and every 12 weeks (±7 days) thereafter up to 2 years or until progressive disease or unacceptable toxicity.]
Stable Disease (SD) per RECIST v1.1 Based on Investigator's Assessment [From Day 1 of Cycle 1 (each cycle is 21 days [3 weeks]) until every 9 weeks (±7 days) for 12 months, and every 12 weeks (±7 days) thereafter up to 2 years or until progressive disease or unacceptable toxicity.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Key Inclusion Criteria:

Histologically or cytologically confirmed diagnosis of metastatic or locally advanced solid tumor for which no acceptable standard therapy available or progressed on or after standard therapies.
Measurable disease on baseline imaging based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
Life expectancy of at least 3 months and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Key Exclusion Criteria:

Active infection requiring treatment.
Lack of recovery for participants who had major surgical procedure within 4 weeks prior to first dose of protocol therapy.
Clinically significant cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥ II), or serious uncontrolled cardiac arrhythmia requiring medication.
Corrected QT interval (QTc) (corrected for heart rate using Fridericia's formula prolongation) >480 msec at screening except for right bundle branch block.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	START Midwest	Grand Rapids	Michigan	United States	49546
2	University of Cincinnati Cancer Center	Cincinnati	Ohio	United States	45267
3	Providence Cancer Institute	Portland	Oregon	United States	97213
4	Lifespan Cancer Institute	Providence	Rhode Island	United States	02903
5	Mary Crowley Cancer Research	Dallas	Texas	United States	75251
6	MD Anderson Cancer Center Thoracic-Head & Neck Med Onc	Houston	Texas	United States	77030