Advanced CancerPhase 1NCT05025085
A Study Investigating AGEN1777 in Participants With Advanced Solid Tumors
A Phase 1 study testing AGEN1777 and a PD-1 inhibitor in people with Advanced Cancer, run by Agenus Inc. at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- AGEN1777 and a PD-1 inhibitor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 11 sitesUnited States
- Study dates
- 4 Oct 2021to 1 Apr 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Local Institution - 072
Cincinnati, Ohio, 45267-0558
University of Cincinnati Cancer Center
Cincinnati, Ohio, 45267
Local Institution - 164
Dallas, Texas, 75230
Mary Crowley Cancer Research
Dallas, Texas, 75251
Local Institution - 165
Grand Rapids, Michigan, 49546
START Midwest
Grand Rapids, Michigan, 49546
MD Anderson Cancer Center Thoracic-Head & Neck Med Onc
Houston, Texas, 77030
Providence Cancer Institute
Portland, Oregon, 97213
Lifespan Cancer Institute
Providence, Rhode Island, 02903
Local Institution - 0001
Providence, Rhode Island, 02903
Local Institution - 024
Southfield, Michigan, 48075
About this study
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
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.
- Conditions
- Advanced Cancer
- Being tested
- AGEN1777, a PD-1 inhibitor
- Keywords
- Solid Tumors, Dose Escalation, Monotherapy, Combination Therapy, Anti-PD-1, Undisclosed Target
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGEN1777Drug
An immunoglobulin gamma (IgG1) antibody
a PD-1 inhibitorDrug
Anti-programmed cell death protein 1 (Anti-PD-1) antibody monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy with AGEN1777 | Experimental | 3+3 Dose escalation of AGEN1777 will be administered by Intravenous (IV) infusion every 3 weeks (each cycle is 21 days [3 weeks]). Receives: Drug: AGEN1777 |
| AGEN1777 in combination with a PD-1 inhibitor | Experimental | 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. Receives: Drug: AGEN1777; Drug: a PD-1 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Dose-Limiting Toxicities (DLT) of AGEN1777 as a Single-Agent and in Combination with a PD-1 inhibitor
Measured: Day 1 through Day 21
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Measured: Up to 2 years and 90 days
Secondary outcomes (7)
Maximum Observed Concentration at Steady State (Cmax-ss) of Serum AGEN1777 and a PD-1 inhibitor
Measured: Day 1 Up to End of Treatment (up to 2 years)
Serum AGEN1777 Anti-Drug Antibody (ADA) Determination
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start4 Oct 2021
- Primary completion11 Jul 2023
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Dose escalation
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agenus Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025085
- Sponsor's protocol ID
- CA115-P01
- Other IDs
- C-1400-01
- Status last verified
- Oct 2025
- First submitted
- 10 Aug 2021
- Last updated
- 15 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05025085
- Acronym / sponsor ID
- CA115-P01
- Conditions
- Advanced Cancer
- Keywords
- Solid Tumors, Dose Escalation, Monotherapy, Combination Therapy, Anti-PD-1, Undisclosed Target
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Agenus Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 11 Jul 2023 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 27 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Dose escalation
| Arm | Type | Receives |
|---|---|---|
| Monotherapy with AGEN1777 | Experimental | Drug: AGEN17773+3 Dose escalation of AGEN1777 will be administered by Intravenous (IV) infusion every 3 weeks (each cycle is 21 days [3 weeks]). |
| AGEN1777 in combination with a PD-1 inhibitor | Experimental | Drug: AGEN1777, Drug: a PD-1 inhibitor3+3 Dose escalation of AGEN1777 in combination with a PD-1 inhibitor will be administered by IV infusion with specified dose on specified days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AGEN1777An immunoglobulin gamma (IgG1) antibody | Drug | AGEN1777 in combination with a PD-1 inhibitor, Monotherapy with AGEN1777 |
| a PD-1 inhibitorAnti-programmed cell death protein 1 (Anti-PD-1) antibody monoclonal antibody | Drug | AGEN1777 in combination with a PD-1 inhibitor |
Primary outcome
Number of Participants with Dose-Limiting Toxicities (DLT) of AGEN1777 as a Single-Agent and in Combination with a PD-1 inhibitor
Time frame: Day 1 through Day 21
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 2 years and 90 days
7 secondary outcomes
Maximum Observed Concentration at Steady State (Cmax-ss) of Serum AGEN1777 and a PD-1 inhibitor
Time frame: Day 1 Up to End of Treatment (up to 2 years)
Serum AGEN1777 Anti-Drug Antibody (ADA) Determination
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AGEN1777 and a PD-1 inhibitor in people with Advanced Cancer, run by Agenus Inc. at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Dose-Limiting Toxicities (DLT) of AGEN1777 as a Single-Agent and in Combination with a PD-1 inhibitor (time frame: Day 1 through Day 21). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2025.