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Advanced Solid TumorPhase 1NCT05377528

Study of AGEN1571 in Participants With Advanced Solid Tumors

A Phase 1 study testing AGEN1571, Balstilimab and Botensilimab in people with Advanced Solid Tumor, run by Agenus Inc. at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an open-label, Phase 1, 2-part trial to determine recommended phase 2 doses (RP2Ds) and evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic profiles of AGEN1571 both as a monotherapy and in combination with balstilimab (PD-1 inhibitor) and/or botensilimab (2-agent combination or 3-agent… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
AGEN1571, Balstilimab and Botensilimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
6 sitesUnited States
Study dates
19 Jul 2022to 23 Dec 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

  • Voluntarily agree to participate by giving signed, dated, and written informed consent prior to any study-specific procedures (participation in genetic testing is optional).
  • Histologically confirmed diagnosis of a solid tumor that is currently metastatic or locally advanced for which no standard therapy is available or standard therapy has failed.
  • Measurable disease on baseline imaging based on RECIST 1.1.
  • Life expectancy of at least 3 months.
  • Eastern Cooperative Oncology Group performance status of 0 or 1.
  • Adequate organ and bone marrow reserve function, as indicated by the following laboratory values:
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  • Adequate hematological function, defined as absolute neutrophil count ≥ 1.5 × 10^9/liter (L), platelet count ≥ 100 × 10^9/L, and hemoglobin ≥ 8 grams (g)/deciliter (dL) without recent transfusion (defined as a transfusion that has occurred within 2 weeks of the hemoglobin measurement).
  • Adequate liver function, defined as serum albumin ≥ 3.0 g/dL, total bilirubin level ≤ 1.5 × institutional upper limit of normal (IULN), aspartate aminotransferase ≤ 2.5 × IULN, and alanine aminotransferase ≤ 2.5 × IULN, and alkaline phosphatase ≤ 2.5 × IULN or ≤ 5 × IULN for participants with liver metastases.
  • Adequate renal function defined as calculated creatinine clearance ≥ 40 milliliters/minute as assessed by Cockcroft-Gault method.
  • Adequate coagulation, defined as international normalized ratio or prothrombin time ≤ 1.5 × IULN and activated partial thromboplastin time ≤ 1.5 × IULN (unless participant is receiving anticoagulant therapy).
  • Participants with a history of prior malignancy are eligible if treatment was completed ≥ 2 years prior to the first dose of study treatment and the participant has no evidence of disease. Participants who have been maintained on stable doses of antineoplastic hormonal therapy within that 2-year time frame may also be eligible with approval of the Medical Monitor. Participants with a history of prior early-stage basal/squamous cell skin cancer, or noninvasive or in situ cancers, who have undergone definitive treatment at any time are also eligible.
  • Participants must provide a sufficient and adequate formalin-fixed paraffin embedded tumor tissue sample (biopsy) collected after the last dose of prior anti-cancer therapy and before the first dose of study treatment from a site not previously irradiated and agree to a mandatory on-treatment biopsy, if clinically feasible. If a potential study participant cannot provide a tumor tissue sample as specified above, enrollment may be possible following discussion and approval from the Medical Monitor.
  • Female participants of childbearing potential must have a negative urine or serum pregnancy test at screening (within 72 hours of first dose of study medication) with repeat urine or serum pregnancy test on Day 1 of each cycle and at the End of Treatment visit. If a urine pregnancy test is positive, results must be confirmed with a serum pregnancy test. Non-childbearing potential is defined as follows:
  • ≥ 50 years of age and has not had menses for greater than 1 year.
  • Amenorrheic for ≥ 2 years without a hysterectomy and bilateral oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon pre-study (screening) evaluation.
  • Status is post hysterectomy, bilateral oophorectomy, or tubal ligation.
  • Female participants who are diagnosed with a tumor that is known to secrete human chorionic gonadotropin must be certified not pregnant based on clinical evidence and investigator judgment.
  • Female participants of child-bearing potential must agree to use highly effective contraceptive measures starting with the screening visit through 90 days after the last dose of study treatment.
  • Note: Abstinence is acceptable if this is the established and preferred contraception for the participant.
  • Male participants with a female partner(s) of childbearing potential must agree to use highly effective contraceptive measures throughout the study starting with the screening visit through 90 days after the last dose of study treatment is received. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner.
  • Note: Abstinence is acceptable if this is the established and preferred contraception for the participant.
  • Willing and able to comply with the requirements of the protocol.

Who cannot join

  • Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 3 weeks of first dose of current study drug.
  • Received prior systemic cytotoxic chemotherapy, biological therapy, radiotherapy, or major surgery outside of the acceptable washout periods prior to first dose of study drug. The following washout windows are acceptable from prior treatments, that is participants with time periods less than the following should be excluded:
  • Cytotoxic agent or monoclonal antibody ≥ 3 weeks is acceptable (that is, < 3 weeks should be excluded).
  • A 1-week washout is permitted for palliative radiation to non-central nervous system (CNS) disease.
  • Small molecule targeted investigational therapies and tyrosine kinase inhibitors ≥ 14 days or 5 half-lives is acceptable (that is, < 14 days or < 5 half-lives should be excluded).
  • Having a previous severe acute respiratory syndrome coronavirus 2 vaccine > 7 days before administration is acceptable. For vaccines requiring more than 1 dose, the full series should be completed prior to Cycle 1 Day 1 (C1D1), when feasible, and when the delay in initiation of study treatment would not put the study participants at risk.
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  • Prior radiation therapy to the CNS within 2 weeks before first treatment.
  • Persistent toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 Grade >1 severity that is related to prior therapy.
  • Sensory neuropathy or alopecia of Grade ≤ 2 is acceptable. Stable, compensated endocrinopathies (hypothyroidism, adrenal insufficiency, hypophysitis) that are the sequelae of immune-mediated adverse events > Grade 1 are acceptable.
  • Known severe (Grade ≥ 3) hypersensitivity reactions to fully human monoclonal antibodies, or to any study drug excipients, or severe reaction to immuno-oncology agents, such as colitis or pneumonitis requiring treatment with steroids; or has a history of or active interstitial lung disease, any history of anaphylaxis, or uncontrolled asthma.
  • Participants with a condition requiring systemic treatment with either corticosteroids (> 10 milligrams [mg] daily prednisone equivalent) within 14 days or any other immunosuppressive medication within 30 days of the first dose of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses (≤ 10 mg daily prednisone equivalent), are permitted in the absence of active autoimmune disease.
  • Active CNS metastases. Note: Participants are eligible if CNS metastases have been treated and participants are radiologically and clinically stable. Participants must have been either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone or equivalent for at least 2 weeks prior to the first dose of study treatment.
  • Active or history of autoimmune disease that requires systemic treatment within 2 years of the start of study drug (that is, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Note: Participants with autoimmune conditions requiring hormone replacement therapy or topical treatments are eligible.
  • Participants has had an allogeneic tissue/solid organ transplant, except for corneal transplants.
  • An active infection requiring treatment within 2 weeks of C1D1, or active interstitial lung disease.
  • Human immunodeficiency virus (HIV) positive:
  • Participants with cluster of differentiation 4 > 200 cells/cubic millimeter are eligible.
  • Participants with undetectable HIV viral load are eligible.
  • Active hepatitis B (HBV) or active hepatitis C (HCV).
  • Participants with HBV infection are eligible if HBV surface antigen and HBV DNA are negative.
  • Participants with HCV infection are eligible if HCV RNA is negative.
  • Clinically significant (that is, active) 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.
  • History or current evidence of any condition (including psychiatric or substance abuse disorder that would interfere with the requirements of the trial), therapy, any active infection requiring treatment within 2 weeks of C1D1, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating Investigator.
  • Legally incapacitated or has limited legal capacity.
  • Pregnant or breastfeeding.
  • Corrected QT interval (QTc) > 480 milliseconds at screening except if the prolonged QTc is due to right bundle branch block.
  • Uncontrolled hypertension or controlled hypertension (> 140/90 millimeters of mercury) on more than 3 antihypertensive agents.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Sarah Cannon Research Institute at HealthONE

    Denver, Colorado, 80218

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Lifespan Cancer Institute

    Providence, Rhode Island, 02903

  • Florida Cancer Specialists

    Sarasota, Florida, 34232

Other trials in United States

About this study

Official title: A Phase 1 Study Investigating AGEN1571 as a Single Agent and in Combination With a PD-1 Inhibitor and/or Botensilimab (AGEN1181) in Patients With Advanced Solid Tumors

This is an open-label, Phase 1, 2-part trial to determine recommended phase 2 doses (RP2Ds) and evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic profiles of AGEN1571 both as a monotherapy and in combination with balstilimab (PD-1 inhibitor) 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.

Being tested
AGEN1571, Balstilimab, Botensilimab
Keywords
Advanced Cancer, Open-label, Dose Escalation, Dose Expansion, Monotherapy, Combination Therapy, Anti-CTLA-4, Anti-PD-1, ILT2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AGEN1571Drug

    A fully human monoclonal immunoglobulin-like transcript antagonist antibody administered intravenously.

  • BalstilimabDrug

    Also called AGEN2034

    A fully human monoclonal programmed cell death protein 1 antagonist antibody administered intravenously.

  • BotensilimabDrug

    Also called AGEN1181

    A fully human fragment crystallizable-enhanced monoclonal cytotoxic T lymphocyte antigen 4 antibody administered intravenously.

Study groups in NCT05377528
Study groupRoleWhat they receive
Dose Escalation: AGEN1571ExperimentalParticipants will receive AGEN1571 monotherapy.
Receives: Drug: AGEN1571
Dose Escalation: AGEN1571 + BalstilimabExperimentalParticipants will receive AGEN1571 with balstilimab.
Receives: Drug: AGEN1571; Drug: Balstilimab
Dose Escalation: AGEN1571 + BotensilimabExperimentalParticipants will receive AGEN1571 with botensilimab.
Receives: Drug: AGEN1571; Drug: Botensilimab
Dose Escalation: AGEN1571 + Balstilimab + BotensilimabExperimentalParticipants will receive AGEN1571 with balstilimab and botensilimab.
Receives: Drug: AGEN1571; Drug: Balstilimab; Drug: Botensilimab
Dose ExpansionExperimentalAGEN1571 administered at the RP2D for monotherapy or any combination therapy.
Receives: Drug: AGEN1571; Drug: Balstilimab; Drug: Botensilimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number Of Participants With Dose-limiting Toxicities

    Measured: Day 1 through Day 42

  2. Number Of Participants With Treatment-emergent Adverse Events

    Measured: Day 1 up to 12 months after the last dose

Secondary outcomes (10)

  1. Serum AGEN1571 Concentration

    Measured: Day 1 up to 90 days after the last dose

  2. Serum Balstilimab Concentration

    Measured: Day 1 up to 90 days after the last dose

  3. Serum Botensilimab Concentration

    Measured: Day 1 up to 90 days after the last dose

  4. Number Of Participants With Anti-drug Antibodies

    Measured: Day 1 up to 90 days after the last dose

  5. Overall Response Rate (ORR)

    ORR will be determined using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).

    Measured: Day 1 up to 90 days after the last dose

  6. Complete Response (CR) Rate

    CR will be determined using RECIST 1.1.

    Measured: Day 1 up to 90 days after the last dose

  7. Partial Response (PR) Rate

    PR will be determined using RECIST 1.1.

    Measured: Day 1 up to 90 days after the last dose

  8. Duration Of Response (DOR)

    DOR will be determined using RECIST 1.1.

    Measured: Day 1 up to 90 days after the last dose

  9. Disease Control Rate (DCR)

    DCR will be determined using RECIST 1.1.

    Measured: Day 1 up to 90 days after the last dose

  10. Progression-free Survival (PFS)

    PFS will be determined using RECIST 1.1.

    Measured: Day 1 up to 90 days after the last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2022
  2. Study start19 Jul 2022
  3. Primary completion23 Dec 2024
  4. Study completion23 Dec 2024

Resources

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05377528
Sponsor's protocol ID
C-1500-01
Status last verified
Apr 2025
First submitted
12 May 2022
Last updated
30 Apr 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AGEN1571, Balstilimab and Botensilimab in people with Advanced Solid Tumor, run by Agenus Inc. at 6 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 22 inclusion and 27 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 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 (time frame: Day 1 through Day 42). 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?

On the ClinicalTrials.gov record for NCT05377528.

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 30 Apr 2025.

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