Advanced Solid TumorPhase 1NCT04156100
A Study in Subjects With Advanced Solid Tumors
A Phase 1 study testing AGEN1223 and AGEN1223 and balstilimab in people with Advanced Solid Tumor, run by Agenus Inc. at 4 sites in United States.
Trial summary
This study is an open-label, Phase 1 study to evaluate the safety, tolerability, PK, and pharmacodynamic profiles of AGEN1223 as a single-agent and in combination with balstilimab, as well as to assess the maximum tolerated dose and determine the RP2D of AGEN1223 as a single-agent and in combination with balstilimab… 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?
- AGEN1223 and AGEN1223 and balstilimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 4 sitesUnited States
- Study dates
- 10 Dec 2019to 29 Sep 2021
- 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).
- Greater than or equal to 18 years of age
- Histologically or cytologically confirmed diagnosis of an advanced solid tumor 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 and an ECOG performance status of 0 or 1 (Appendix A).
- Adequate organ function as indicated by the following laboratory values:
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- Adequate hematological function, defined as ANC ≥1.5 × 109/L, platelet count ≥100 × 109/L, and hemoglobin ≥8 g/dL without recent transfusion (defined as a transfusion that has occurred within 2 weeks of the hemoglobin measurement).
- Adequate hepatic function based by a total bilirubin level ≤1.5 × the institutional upper limit of normal (IULN), AST level ≤2.5 × IULN, ALT level ≤2.5 × IULN.
- Adequate renal function defined as creatinine ≤1.5 × IULN or measured or calculated creatinine clearance >40 mL/min per institutional standard. Assessment methods should be recorded.
- Adequate coagulation defined by international normalized ratio or prothrombin time ≤1.5 × IULN and activated partial thromboplastin time ≤1.5 × IULN (unless the subject is receiving anticoagulant therapy).
- No history of prior or concomitant malignancy that requires other active treatment.
- Subjects must provide a sufficient and adequate FFPE tumor tissue sample (fresh biopsy) collected within 28 days before the first dose from a site not previously irradiated and to agree to a mandatory on-treatment biopsy if clinically feasible.
- Female subjects of child-bearing potential must have a negative serum pregnancy test at screening (within 72 hours of first dose of study medication). Subjects with tumors producing human chorionic gonadotropin and gestational trophoblastic tumor do not need a serum pregnancy test, and absence of pregnancy should be documented by the Principal Investigator (PI) based on clinical and radiological assessments as needed. Non-childbearing potential is defined as:
- ≥45 years of age and has not had menses for greater than 1 year,
- Amenorrheic for ≥2 years without a hysterectomy and oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon prestudy (screening) evaluation,
- Status is post-hysterectomy, oophorectomy, or tubal ligation.
- Female subjects of child-bearing potential must be willing 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 subject.
- Male subjects with a female partner(s) of child-bearing 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 method for the subject.
- 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 investigation device within 3 weeks of the first dose of current study drug.
- Any relevant bispecific antibody, and/or anti-PD-1/PDL1 agents. For selected indication cohorts, prior treatment may be permitted after discussion with the Sponsor. Prior therapy with PD-1/PDL1 inhibitor may be allowed in agreement with the Sponsor.
- Received prior systemic cytotoxic chemotherapy, biological therapy, radiotherapy, or major surgery within 3 weeks prior to first dose of study drug; a 1-week washout is permitted for palliative radiation to non-central nervous system (CNS) disease with Sponsor approval.
- Persisting toxicity with Grade >1 severity related to prior therapy based on NCI-CTCAE Version 5.0.
- Note: Sensory neuropathy and alopecia of Grade ≤2 are acceptable.
- Expected to require any other form of systemic or localized antineoplastic therapy while on study (including maintenance therapy with another agent, radiation therapy, and/or surgical resection).
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- Known severe hypersensitivity reactions (NCI-CTCAE Grade ≥3) to fully human monoclonal antibodies, or severe reaction to immuno-oncology agents, such as colitis or pneumonitis, requiring treatment with steroids, or has a history of interstitial lung disease (ILD), any history of anaphylaxis, or uncontrolled asthma.
- Receiving systemic corticosteroid therapy 1 week prior to the first dose of study drug or receiving any other form of systemic immunosuppressive medication.
- Note: Corticosteroid use as a premedication for IV contrast allergies/reactions is allowed. Subjects who are receiving daily corticosteroid replacement therapy are an exception to this rule. Daily prednisone at doses of up to 7.5 mg or equivalent hydrocortisone doses are examples of permitted replacement therapy. Use of inhaled or topical corticosteroids is permitted.
- CNS tumor, metastasis, and/or carcinomatous meningitis identified either on the baseline brain imaging obtained during the screening period or identified prior to consent.
- Note: Subjects with history of brain metastases that have been treated may participate provided they show evidence of stable supra-tentorial lesions at screening (defined as 2 brain images, both of which 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. Any steroids administered as part of this therapy must be completed ≥3 days prior to the first dose of study medication.
- Active or history of autoimmune disease that has required systemic treatment within 2 years of the start of study treatment (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs).
- Note: Subjects with diabetes type 1, vitiligo, psoriasis, and hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible.
- Allogeneic tissue/solid organ transplant, except those not requiring immuno-suppressive treatment.
- Active infection requiring treatment.
- History of human immunodeficiency virus (HIV) type 1 or 2 antibodies.
- Known active hepatitis B whose virus load is greater than 500 IU/mL.
- Clinically significant (i.e., 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, therapy, active infections, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
- Legally incapacitated or has limited legal capacity.
- Pregnant or breastfeeding.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Southern California
Los Angeles, California, 90033
University of Miami/Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Abramson Cancer Center at the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
HonorHealth Research Institute
Scottsdale, Arizona, 85258
About this study
Official title: A Phase 1 Study of AGEN1223, a Bispecific Fc-Engineered Antibody as a Single Agent and in Combination With Balstilimab, an Anti-PD-1 Monoclonal Antibody, in Subjects With Advanced Solid Tumors
This study is an open-label, Phase 1 study to evaluate the safety, tolerability, PK, and pharmacodynamic profiles of AGEN1223 as a single-agent and in combination with balstilimab, as well as to assess the maximum tolerated dose and determine the RP2D of AGEN1223 as a single-agent and in combination with balstilimab in subjects with advanced solid tumors.
Read the detailed description
This study is an open-label, Phase 1 study to evaluate the safety, tolerability, PK, and pharmacodynamic profiles of AGEN1223 as a single-agent and in combination with balstilimab, as well as to assess the maximum tolerated dose and determine the RP2D of AGEN1223 as a single-agent and in combination with balstilimab in subjects with advanced solid tumors. This Phase 1 study will be conducted in an accelerated titration (for the first 2 single agent AGEN1223 dosing cohorts) and standard 3+3 dose escalation format. Study drug treatment will be administered on Day 1 of each 3-week cycle for up to 2 years or until any progressive disease (PD) or unacceptable toxicity is reported. The timing of the administration of doses may be adjusted for management of adverse events (AEs). The safe starting dose of AGEN1223 single-agent will be at the estimated minimally anticipated biological effect level.
The treatment phase is divided into 3-week cycles with associated evaluations and procedures that must be performed at specific time points. Tumor assessments will be conducted every 6 weeks (±7 days) from first dose until treatment discontinuation or disease progression. In subjects that discontinue treatment for reasons other than PD, imaging will continue until PD or initiation of a new therapy. If the subject discontinues treatment because of PD, imaging may be performed if clinically beneficial or if deemed necessary by the investigator until the initiation of new antineoplastic therapy. This must be approved by the Sponsor.
A Safety Monitoring Committee (SMC) will be established to assess safety and determine dose escalation.
- Conditions
- Advanced Solid Tumor
- Being tested
- AGEN1223, AGEN1223 and balstilimab
- Keywords
- Cancer, Solid Tumor, PD-L1
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGEN1223Drug
AGEN1223 is a bispecific antibody.
AGEN1223 and balstilimabDrug
AGEN1223 is a bispecific antibody and balstilimab an anti-PD-1 Monoclonal Antibody.
| Study group | Role | What they receive |
|---|---|---|
| AGEN1223 | Experimental | AGEN1223 is a bispecific antibody. Receives: Drug: AGEN1223 |
| AGEN1223 and balstilimab | Experimental | AGEN1223 is a bispecific antibody and balstilimab an anti-PD-1 Monoclonal Antibody Receives: Drug: AGEN1223 and balstilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity (DLT)
In subjects in dose escalation
Measured: First 28 days of treatment
Frequency, severity, and duration of treatment-emergent AEs (TEAEs)
For all dose groups according to NCI-CTCAE Version 5.0
Measured: Screening through 90 days after last dose
Secondary outcomes (15)
Maximum observed concentration at steady state (Cmax-ss)
PK profile of AGEN1223 and balstilimab
Measured: From first dose through 2 year of treatment
Minimum observed concentration at steady state (Cmin-ss)
PK Profile of AGEN1223 and balstilimab
Measured: From first dose through 2 year of treatment
Area under the plasma/serum concentration-time curve within time span t1 to t2 at steady-state (AUC(t1-t2)-ss)
PK Profile of AGEN1223 and balstilimab
Measured: From first dose through 2 year of treatment
Area under the plasma/serum concentration-time curve from time zero to time t (AUC(0-t))
PK Profile of AGEN1223 and balstilimab
Measured: From first dose through 2 year of treatment
Area under the plasma/serum concentration-time curve from time zero to infinity (AUC(0-∞))
PK Profile of AGEN1223 and balstilimab
Measured: From first dose through 2 year of treatment
Time to maximum observed concentration (tmax)
PK Profile of AGEN1223 and balstilimab
Measured: From first dose through 2 year of treatment
terminal disposition rate constant (λz)
PK Profile of AGEN1223 and balstilimab
Measured: From first dose through 2 year of treatment
Terminal elimination half-life (t1/2)
PK Profile of AGEN1223 and balstilimab
Measured: From first dose through 2 year of treatment
Systemic clearance (CL)
PK Profile of AGEN1223 and balstilimab
Measured: From first dose through 2 year of treatment
Volume of distribution (Vd).
PK Profile of AGEN1223 and balstilimab
Measured: From first dose through 2 year of treatment
Immunogenicity
Incidence of anti-AGEN1223 antibodies and anti-Balstilimab antibodies
Measured: From first dose through 2 year of treatment
Overall Response Rate
Per RECIST 1.1 based on Investigator assessment
Measured: Screening up to 2 years of treatment
Duration of Response
Per RECIST 1.1 based on Investigator assessment
Measured: Screening up to 2 years of treatment
Disease Control Rate
Including complete and partial responders and stable disease (SD) for at least 12 weeks, per RECIST 1.1 based on Investigator assessment.
Measured: Screening up to 2 years of treatment
Progression-free Survival median and/or rate
As defined in the Statistical Analysis Plan
Measured: Screening up to 2 years of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start10 Dec 2019
- Primary completion8 Apr 2021
- Study completion29 Sep 2021
Why it stopped: Strategic business decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 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
- NCT04156100
- Sponsor's protocol ID
- C-900-01
- Status last verified
- Feb 2022
- First submitted
- 18 Sep 2019
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of AGEN1223, a Bispecific Fc-Engineered Antibody as a Single Agent and in Combination With Balstilimab, an Anti-PD-1 Monoclonal Antibody, in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04156100
- Acronym / sponsor ID
- C-900-01
- Conditions
- Advanced Solid Tumor
- Keywords
- Cancer, Solid Tumor, PD-L1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic business decision.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Agenus Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 8 Apr 2021 (actual)
- Study completion
- 29 Sep 2021 (actual)
- First posted
- 7 Nov 2019 (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 an open-label, Phase 1 study to evaluate the safety, tolerability, PK, and pharmacodynamic profiles of AGEN1223 as a single-agent and in combination with balstilimab, as well as to assess the maximum tolerated dose and determine the RP2D of AGEN1223 as a single-agent and in combination with balstilimab in subjects with advanced solid tumors.
Detailed description
This study is an open-label, Phase 1 study to evaluate the safety, tolerability, PK, and pharmacodynamic profiles of AGEN1223 as a single-agent and in combination with balstilimab, as well as to assess the maximum tolerated dose and determine the RP2D of AGEN1223 as a single-agent and in combination with balstilimab in subjects with advanced solid tumors. This Phase 1 study will be conducted in an accelerated titration (for the first 2 single agent AGEN1223 dosing cohorts) and standard 3+3 dose escalation format. Study drug treatment will be administered on Day 1 of each 3-week cycle for up to 2 years or until any progressive disease (PD) or unacceptable toxicity is reported. The timing of the administration of doses may be adjusted for management of adverse events (AEs). The safe starting dose of AGEN1223 single-agent will be at the estimated minimally anticipated biological effect level.
The treatment phase is divided into 3-week cycles with associated evaluations and procedures that must be performed at specific time points. Tumor assessments will be conducted every 6 weeks (±7 days) from first dose until treatment discontinuation or disease progression. In subjects that discontinue treatment for reasons other than PD, imaging will continue until PD or initiation of a new therapy. If the subject discontinues treatment because of PD, imaging may be performed if clinically beneficial or if deemed necessary by the investigator until the initiation of new antineoplastic therapy. This must be approved by the Sponsor.
A Safety Monitoring Committee (SMC) will be established to assess safety and determine dose escalation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AGEN1223 | Experimental | Drug: AGEN1223AGEN1223 is a bispecific antibody. |
| AGEN1223 and balstilimab | Experimental | Drug: AGEN1223 and balstilimabAGEN1223 is a bispecific antibody and balstilimab an anti-PD-1 Monoclonal Antibody |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Voluntarily agree to participate by giving signed, dated, and written informed consent prior to any study specific procedures (participation in genetic testing is optional).
- Greater than or equal to 18 years of age
- Histologically or cytologically confirmed diagnosis of an advanced solid tumor 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 and an ECOG performance status of 0 or 1 (Appendix A).
Key exclusion criteria (22 listed)
- Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigation device within 3 weeks of the first dose of current study drug.
- Any relevant bispecific antibody, and/or anti-PD-1/PDL1 agents. For selected indication cohorts, prior treatment may be permitted after discussion with the Sponsor. Prior therapy with PD-1/PDL1 inhibitor may be allowed in agreement with the Sponsor.
- Received prior systemic cytotoxic chemotherapy, biological therapy, radiotherapy, or major surgery within 3 weeks prior to first dose of study drug; a 1-week washout is permitted for palliative radiation to non-central nervous system (CNS) disease with Sponsor approval.
- Persisting toxicity with Grade >1 severity related to prior therapy based on NCI-CTCAE Version 5.0.
- Note: Sensory neuropathy and alopecia of Grade ≤2 are acceptable.
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 |
|---|---|---|
| AGEN1223AGEN1223 is a bispecific antibody. | Drug | AGEN1223 |
| AGEN1223 and balstilimabAGEN1223 is a bispecific antibody and balstilimab an anti-PD-1 Monoclonal Antibody. | Drug | AGEN1223 and balstilimab |
Primary outcome
Dose Limiting Toxicity (DLT)
Time frame: First 28 days of treatment
In subjects in dose escalation
Frequency, severity, and duration of treatment-emergent AEs (TEAEs)
Time frame: Screening through 90 days after last dose
For all dose groups according to NCI-CTCAE Version 5.0
15 secondary outcomes
Maximum observed concentration at steady state (Cmax-ss)
Time frame: From first dose through 2 year of treatment
Minimum observed concentration at steady state (Cmin-ss)
Time frame: From first dose through 2 year of treatment
Area under the plasma/serum concentration-time curve within time span t1 to t2 at steady-state (AUC(t1-t2)-ss)
Time frame: From first dose through 2 year of treatment
Area under the plasma/serum concentration-time curve from time zero to time t (AUC(0-t))
Time frame: From first dose through 2 year of treatment
Area under the plasma/serum concentration-time curve from time zero to infinity (AUC(0-∞))
Time frame: From first dose through 2 year of treatment
Time to maximum observed concentration (tmax)
Time frame: From first dose through 2 year of treatment
terminal disposition rate constant (λz)
Time frame: From first dose through 2 year of treatment
Terminal elimination half-life (t1/2)
Time frame: From first dose through 2 year of treatment
Systemic clearance (CL)
Time frame: From first dose through 2 year of treatment
Volume of distribution (Vd).
Time frame: From first dose through 2 year of treatment
Immunogenicity
Time frame: From first dose through 2 year of treatment
Overall Response Rate
Time frame: Screening up to 2 years of treatment
Duration of Response
Time frame: Screening up to 2 years of treatment
Disease Control Rate
Time frame: Screening up to 2 years of treatment
Progression-free Survival median and/or rate
Time frame: Screening up to 2 years of treatment
Results and safety
The study was stopped early (reason given: Strategic business decision.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- 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.
4 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 AGEN1223 and AGEN1223 and balstilimab in people with Advanced Solid Tumor, run by Agenus Inc. at 4 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 21 inclusion and 22 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: stopped early, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 was stopped early (reason given: Strategic business decision.). Results are not available in the source record.
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?
Dose Limiting Toxicity (DLT) (time frame: First 28 days of treatment). 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 3 Mar 2022.