Advanced Solid CancersPhase 1/2NCT02694822
AGEN1884, an Anti-CTLA-4 Human Monoclonal Antibody in Participants With Advanced or Refractory Cancer and Who Have Progressed With PD-1/PD-L1 Inhibitor as Their Most Recent Therapy
A Phase 1/2 study testing Zalifrelimab in people with Advanced Solid Cancers and Advanced Solid Cancers Refractory to PD-1 and PD-L1 Therapies, run by Agenus Inc. at 11 sites in United States.
Trial summary
This is an open-label, Phase 1/2, multicenter study to evaluate the safety, pharmacokinetics, and pharmacodynamics of an anti-cytotoxic T lymphocyte-associated protein-4 (CTLA-4) human monoclonal antibody (zalifrelimab) in participants with advanced or refractory cancer and in participants who have progressed during… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Cancers, Advanced Solid Cancers Refractory to PD-1 and PD-L1 Therapies
- What is being tested?
- Zalifrelimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 11 sitesUnited States
- Study dates
- Apr 2016to 31 Mar 2022
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Written informed consent.
- ≥18 years of age.
- Histological or cytological diagnosis of solid cancer or lymphoma that is considered incurable and without therapies with established benefit. Biopsy is not necessary for participants with known prior diagnosis, and clinical or radiographic evidence of recurrence. For Phase 2 only: Participants who experienced documented disease progression during treatment with an approved or investigational PD-1/PD-L1 inhibitor as their most recent therapy (2-6 weeks prior to first dose of study drug). This cohort includes participants with histological diagnoses of hepatocellular carcinoma (HCC) (not including atypical histology such as cholangiocarcinoma mix or fibrolamellar hepatocellular carcinoma) who experienced documented disease progression during treatment with an approved or investigational PD-1/PD-L1 inhibitor as their most recent therapy (2-6 weeks prior to first dose of study drug).
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
- Participants in Phase 2 with HCC should have a Child-Pugh score of A or B7 with no encephalopathy or ascites.
- Life expectancy ≥12 weeks.
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- Adequate cardiac function (New York Heart Association [NYHA] class ≤II).
- Adequate organ function, defined as absolute neutrophil count (ANC) ≥1,500×10^6/liter (L), absolute lymphocyte count ≥500/cubic millimeters (mm^3), hemoglobin ≥8.0 grams/deciliter (g/dL), and platelet count ≥100,000×10^6/mm^3 without blood growth factors or without transfusions within 1 week of first dose. For participants in Phase 2 with HCC: Platelet count ≥60×10^6/mm^3 and ANC ≥1,000×10^6/L are acceptable provided that the principal investigator assesses these abnormalities as due to liver disease.
- Adequate liver function, defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5× institutional upper limit of normal (ULN), and bilirubin ≤1.5 milligrams/deciliter (mg/dL) × ULN. For participants in Phase 2 with HCC: AST and ALT ≤5 × ULN, bilirubin ≤2 mg/dL × ULN, and albumin ≥2.8 mg/dL.
- Adequate renal function, defined as estimated creatinine clearance ≥50 milliliters/minute according to Cockcroft-Gault formula, or measured 24-hour creatinine clearance (or local institutional standard method).
- Adequate coagulation defined by international normalized ratio (INR) or prothrombin time (PT) ≤1.5× ULN (unless the participant is receiving anticoagulant therapy); and activated partial thromboplastin time ≤1.5× ULN (unless the participant is receiving anticoagulant therapy). Participants in Phase 2 with HCC can have an INR ≤2.3× ULN. Note: Participants in Phase 2 with HCC and on anticoagulant treatment would have an assigned value of 1 point when scoring PT/INR so the overall Child-Pugh score is not adversely affected.
- Female participants of childbearing potential and fertile male participants must agree to use adequate contraception or abstain from sexual activity from the time of consent through 90 days after the end of study drug. Adequate contraception includes condoms with contraceptive foam; oral, implantable, or injectable contraceptives; contraceptive patch; intrauterine device; diaphragm with spermicidal gel; or a sexual partner who is surgically sterilized or postmenopausal. Note: Abstinence is acceptable if this is the established and preferred contraception for the participant.
- In the expansion phase, all participants must provide a sufficient and adequate formalin-fixed paraffin embedded (FFPE) tumor tissue sample preferably collected after progression on the last therapy and/or collected at screening, if clinically feasible. If a recent biopsy is not available, an archival FFPE sample should be provided from a site not previously irradiated. If no tumor tissue is available, a fresh biopsy will be required if clinically feasible.
Who cannot join
- Other malignancies treated within the last 5 years, except in situ cervix carcinoma or non-melanoma skin cancer.
- Other form(s) of antineoplastic therapy anticipated during the period of the study.
- Previous severe hypersensitivity reaction to another fully human monoclonal antibody or severe reaction to immuno-oncology agents, such as colitis or pneumonitis requiring treatment with steroids.
- History of interstitial lung disease.
- Primary or secondary immunodeficiency, including immunosuppressive disease, autoimmune disease (including autoimmune endocrinopathies), or usage of immunosuppressive medications.
- Note: Participants with diabetes type 1, vitiligo, psoriasis, hypo-, or hyperthyroid disease not requiring immunosuppressive treatment are eligible. Participants with Type 2 diabetes mellitus are allowed.
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- Participants with a known history of human immunodeficiency virus 1 and 2, human T lymphotropic virus 1.
- Participants in Phase 2 with HCC: Participants with active hepatitis B infection who are receiving effective antiviral therapy are permitted. Participants with active hepatitis C infection are allowed (antiviral therapy not required).
- Administration of anticancer medications or investigational drugs within the following intervals before the first administration of study drug: a. ≤14 days for chemotherapy, targeted small molecule therapy, or radiation therapy. Participants must also not have had radiation pneumonitis as a result of treatment and cannot participate in the study if they are on chronic corticosteroids for radiation pneumonitis. A 1-week washout is permitted for palliative radiation to non-central nervous system (CNS) disease, with medical monitor approval.
- Note: Bisphosphonates and denosumab are permitted medications. b. ≤14 days for prior immunotherapy. Participants in the dose escalation cohorts are excluded if they have received prior checkpoint inhibitors, costimulatory agonists, or immune modulating therapy except as described below. Once a dose level is determined to be safe by the safety review committee, participants will be allowed to enroll in dose-level expansion cohorts if they have received other non-CTLA-4 targeting immunotherapies.
- Participants enrolling in Phase 2 must have cancer that has progressed after prior treatment with an approved or investigational PD-1/PD-L1 inhibitor as their most recent therapy (2-6 weeks prior to first dose of study drug). The minimum requirement of 2 weeks (14 days) from prior anti-PD-1/PD-L1 therapy is to allow resolution of any lower-grade (≤2) adverse events observed with the therapy. If the investigator feels the participant has tolerated prior anti-PD-1/PD-L1 therapy well, then treatment with study agent may begin sooner.
- ≤7 days for prior corticosteroid treatment, with the following exceptions:
- Use of an inhaled or topical corticosteroid is permitted.
- Corticosteroid premedication for radiographic imaging for dye allergies is permitted.
- Use of physiologic corticosteroid replacement therapy may be approved after consultation with the medical monitor. e. ≤21 days for prior monoclonal antibody used for anticancer therapy, with the exception of denosumab. This does not apply to participants being enrolled in Phase 2, who have received a PD-1/PD-L1 inhibitor as their most recent therapy (2-6 weeks prior to first dose of study drug; see above).
- ≤7 days for immunosuppressive-based treatment for any reason, with the exceptions noted above for prior corticosteroid treatment (exclusion criterion d).
- ≤21 days or 5 half-lives before first dose of study treatment for all other investigational study drugs or devices. For investigational agents with long half- lives (for example, >5 days), enrollment before the fifth half-life requires medical monitor approval.
- For participants in Phase 2 with HCC <6 weeks for prior locoregional therapy to the liver, for example, transcatheter chemoembolization, radiation, surgery, or radioembolization.
- Has not recovered to grade ≤1 from toxic effects of prior therapy and/or complications from prior surgical intervention before starting therapy.
- Note: Participants with grade ≤2 neuropathy and alopecia are an exception and may enroll.
- Uncontrolled infection or other serious medical illnesses.
- History or presence of an abnormal electrocardiogram that, in the investigator's opinion, is clinically meaningful.
- Any medical conditions that, in the opinion of the investigator, would preclude use of AGEN1884, including AGEN1884 hypersensitivity.
- Women who are pregnant or breastfeeding.
- Concurrent participation in other investigational drug trials.
- Has a CNS tumor, metastasis(es), and/or carcinomatous meningitis identified either on the baseline brain imaging obtained during the screening period or identified prior to consent. Note: Participants with history of brain metastases that have been treated may participate provided they show evidence of stable supra-tentorial lesions are obtained after treatment to the brain metastases. These imaging scans should both be obtained ≥4 weeks apart). In addition, any neurologic symptoms that developed either as a result of the brain metastases or their treatment must have returned to baseline or resolved. For individuals who received steroids as part of brain metastases treatment, steroids must be discontinued ≥7 days prior to first dose of study drug.
- For participants in Phase 2 with HCC, the following exclusions also apply:
- Recent encephalopathy episodes in the last 6 months.
- Recent (within the last 6 months) gastro-esophageal varices bleeding.
- Participant whose tumors have cardiac involvement, as determined by imaging.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Texas Oncology - Austin Midtown
Austin, Texas, 78705
Levine Cancer Institute
Charlotte, North Carolina, 28204
Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, 60611
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Rocky Mountain Cancer Center
Denver, Colorado, 80218
City of Hope National Medical Center
Duarte, California, 91010
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
University of Miami Miller School of Medicine
Miami, Florida, 33136
Atlantic Health System/Morristown Medical Center
Morristown, New Jersey, 07962
Ochsner Cancer Institute
New Orleans, Louisiana, 70121
Texas Oncology, Tyler Texas
Tyler, Texas, 75702
About this study
Official title: A Phase 1/2, Open-Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of an Anti-CTLA-4 Human Monoclonal Antibody (AGEN1884) in Subjects With Advanced or Refractory Cancer and in Subjects Who Have Progressed During Treatment With a PD-1/PD-L1 Inhibitor as Their Most Recent Therapy
This is an open-label, Phase 1/2, multicenter study to evaluate the safety, pharmacokinetics, and pharmacodynamics of an anti-cytotoxic T lymphocyte-associated protein-4 (CTLA-4) human monoclonal antibody (zalifrelimab) in participants with advanced or refractory cancer and in participants who have progressed during treatment with a programmed cell death protein-1/programmed cell death ligand-1 (PD-1/PD-L1) inhibitor as their most recent therapy.
The phase 1 portion of the study has been completed; it enrolled adult participants with refractory, advanced cancer in a 3+3 dose escalation cohort.
The phase 2 portion consisted of 51 participants who progressed during treatment with an approved or investigational PD-1/PD-L1 inhibitor as their most recent therapy (2-6 weeks prior to first dose of study drug).
- Being tested
- Zalifrelimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZalifrelimabDrug
Also called AGEN1884
An anti-CTLA-4 monoclonal antibody.
| Study group | Role | What they receive |
|---|---|---|
| Zalifrelimab | Experimental | Participants received zalifrelimab intravenously. Receives: Drug: Zalifrelimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Number of Participants With Dose-limiting Toxicities (DLTs) of Zalifrelimab
A DLT was defined as a Grade ≥3 adverse drug reaction (ADR), according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5, occurring in the DLT evaluation period (28 days after the initial administration of zalifrelimab). An ADR was defined as all noxious and unintended responses to a medicinal product, related to any dose.
Measured: Up to 28 days
Phase 1 and Phase 2: Number of Participants Experiencing Any Treatment-related Adverse Events
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. A treatment-related AE was one in which a causal relationship between the medicinal product and the AE was at least a reasonable possibility and could not be ruled out. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Measured: Up to 6 years
Phase 1: Maximum Drug Concentration (Cmax) of Zalifrelimab
Blood samples were collected at designated timepoints to characterize Cmax of serum zalifrelimab following IV infusion in participants with metastatic or locally advanced solid tumors. Data reported as micrograms/milliliter (ug/mL).
Measured: Day 1 of Cycle 1 (21 days/cycle)
Phase 1: Area Under the Drug Concentration-time Curve From 0 to 21 Days (AUC0-21d) of Zalifrelimab
Blood samples were collected at designated timepoints to characterize AUC0-21d of serum zalifrelimab following IV infusion in participants with metastatic or locally advanced solid tumors. Data reported as hour times ug/mL (hour*ug/mL).
Measured: Day 1 of Cycle 1 (21 days/cycle)
Secondary outcomes (7)
Phase 1 and Phase 2: Objective Response Rate (ORR)
ORR was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) as determined by radiographic disease assessments per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1). BOR was defined as the best response recorded from the start of treatment until disease progression/recurrence; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeters. CR was defined as disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: Up to 6 years
Phase 1 and Phase 2: Disease Control Rate (DCR)
DCR was defined as the percentage of participants who had a confirmed response (CR or PR) or stable disease (SD) without progressive disease (PD). SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study).
Measured: Up to 6 years
Phase 1 and Phase 2: Duration of Response (DOR)
DOR was defined as the interval from which the date measurement criteria were met for CR or PR (whichever was first recorded) until the earliest date of disease progression, as determined by investigator assessment of objective radiographic disease assessments per RECIST v1.1, or death due to any cause, if occurring sooner than progression.
Measured: Up to 6 years
Phase 1: Progression-free Survival (PFS)
PFS was defined as the interval from the date of first dose of investigational agent until the earliest date of PD, as determined by independent endpoint review committee assessment of objective radiographic disease assessments per RECIST v1.1, or death due to any cause if occurring sooner than progression.
Measured: Up to 6 years
Phase 2: PFS
PFS was defined as the interval from the date of first dose of investigational agent until the earliest date of PD, as determined by independent endpoint review committee assessment of objective radiographic disease assessments per RECIST v1.1, or death due to any cause if occurring sooner than progression.
Measured: Up to 6 years
Phase 1: Overall Survival (OS)
OS was defined as the interval from the date of first dose of investigational agent until the date of death. For participants who did not die, OS was censored at last contact date.
Measured: Up to 6 years
Phase 2: OS
OS was defined as the interval from the date of first dose of investigational agent until the date of death. For participants who did not die, OS was censored at last contact date.
Measured: Up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2016 (estimated)
- Study startApr 2016
- Primary completion30 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced Solid CancersStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agenus Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Agenus Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02694822
- Sponsor's protocol ID
- C-500-01
- Status last verified
- Feb 2025
- First submitted
- 12 Feb 2016
- Last updated
- 17 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Open-Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of an Anti-CTLA-4 Human Monoclonal Antibody (AGEN1884) in Subjects With Advanced or Refractory Cancer and in Subjects Who Have Progressed During Treatment With a PD-1/PD-L1 Inhibitor as Their Most Recent Therapy
- ClinicalTrials.gov ID
- NCT02694822
- Acronym / sponsor ID
- C-500-01
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Agenus Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2016 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 1 Mar 2016 (estimated)
- Results
- Posted 17 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, Phase 1/2, multicenter study to evaluate the safety, pharmacokinetics, and pharmacodynamics of an anti-cytotoxic T lymphocyte-associated protein-4 (CTLA-4) human monoclonal antibody (zalifrelimab) in participants with advanced or refractory cancer and in participants who have progressed during treatment with a programmed cell death protein-1/programmed cell death ligand-1 (PD-1/PD-L1) inhibitor as their most recent therapy.
The phase 1 portion of the study has been completed; it enrolled adult participants with refractory, advanced cancer in a 3+3 dose escalation cohort.
The phase 2 portion consisted of 51 participants who progressed during treatment with an approved or investigational PD-1/PD-L1 inhibitor as their most recent therapy (2-6 weeks prior to first dose of study drug).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zalifrelimab | Experimental | Drug: ZalifrelimabParticipants received zalifrelimab intravenously. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Written informed consent.
- ≥18 years of age.
- Histological or cytological diagnosis of solid cancer or lymphoma that is considered incurable and without therapies with established benefit. Biopsy is not necessary for participants with known prior diagnosis, and clinical or radiographic evidence of recurrence. For Phase 2 only: Participants who experienced documented disease progression during treatment with an approved or investigational PD-1/PD-L1 inhibitor as their most recent therapy (2-6 weeks prior to first dose of study drug). This cohort includes participants with histological diagnoses of hepatocellular carcinoma (HCC) (not including atypical histology such as cholangiocarcinoma mix or fibrolamellar hepatocellular carcinoma) who experienced documented disease progression during treatment with an approved or investigational PD-1/PD-L1 inhibitor as their most recent therapy (2-6 weeks prior to first dose of study drug).
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
- Participants in Phase 2 with HCC should have a Child-Pugh score of A or B7 with no encephalopathy or ascites.
Key exclusion criteria (30 listed)
- Other malignancies treated within the last 5 years, except in situ cervix carcinoma or non-melanoma skin cancer.
- Other form(s) of antineoplastic therapy anticipated during the period of the study.
- Previous severe hypersensitivity reaction to another fully human monoclonal antibody or severe reaction to immuno-oncology agents, such as colitis or pneumonitis requiring treatment with steroids.
- History of interstitial lung disease.
- Primary or secondary immunodeficiency, including immunosuppressive disease, autoimmune disease (including autoimmune endocrinopathies), or usage of immunosuppressive medications.
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 |
|---|---|---|
| ZalifrelimabAlso: AGEN1884An anti-CTLA-4 monoclonal antibody. | Drug | Zalifrelimab |
Primary outcome
Phase 1: Number of Participants With Dose-limiting Toxicities (DLTs) of Zalifrelimab
Time frame: Up to 28 days
A DLT was defined as a Grade ≥3 adverse drug reaction (ADR), according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5, occurring in the DLT evaluation period (28 days after the initial administration of zalifrelimab). An ADR was defined as all noxious and unintended responses to a medicinal product, related to any dose.
Phase 1 and Phase 2: Number of Participants Experiencing Any Treatment-related Adverse Events
Time frame: Up to 6 years
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. A treatment-related AE was one in which a causal relationship between the medicinal product and the AE was at least a reasonable possibility and could not be ruled out. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Phase 1: Maximum Drug Concentration (Cmax) of Zalifrelimab
Time frame: Day 1 of Cycle 1 (21 days/cycle)
Blood samples were collected at designated timepoints to characterize Cmax of serum zalifrelimab following IV infusion in participants with metastatic or locally advanced solid tumors. Data reported as micrograms/milliliter (ug/mL).
Phase 1: Area Under the Drug Concentration-time Curve From 0 to 21 Days (AUC0-21d) of Zalifrelimab
Time frame: Day 1 of Cycle 1 (21 days/cycle)
Blood samples were collected at designated timepoints to characterize AUC0-21d of serum zalifrelimab following IV infusion in participants with metastatic or locally advanced solid tumors. Data reported as hour times ug/mL (hour*ug/mL).
7 secondary outcomes
Phase 1 and Phase 2: Objective Response Rate (ORR)
Time frame: Up to 6 years
Phase 1 and Phase 2: Disease Control Rate (DCR)
Time frame: Up to 6 years
Phase 1 and Phase 2: Duration of Response (DOR)
Time frame: Up to 6 years
Phase 1: Progression-free Survival (PFS)
Time frame: Up to 6 years
Phase 2: PFS
Time frame: Up to 6 years
Phase 1: Overall Survival (OS)
Time frame: Up to 6 years
Phase 2: OS
Time frame: Up to 6 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Medical Director study director
Agenus Inc.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Zalifrelimab in people with Advanced Solid Cancers and Advanced Solid Cancers Refractory to PD-1 and PD-L1 Therapies, 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 13 inclusion and 30 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 17 Mar 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Phase 1: Number of Participants With Dose-limiting Toxicities (DLTs) of Zalifrelimab (time frame: Up to 28 days). The study lists 4 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 17 Mar 2025.