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Monoclonal Antibodies
AB154 + AB122 for Glioblastoma
Phase < 1
Recruiting
Led By Antonio Omuro, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have adequate organ and marrow function as defined below within 14 days of treatment: Absolute neutrophil count (ANC) ≥1,500 /mcL, Platelets ≥100,000 / mcL, Hemoglobin ≥9 g/dL or ≥ 5.6 mmol/L without transfusion or Erythropoietin (EPO) dependency (within 7 days of assessment), Serum creatinine ≤1.5 X upper limit of normal (ULN) OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≥ 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN, Serum total bilirubin ≤ 1.5 X ULN OR direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN, aspartate aminotransferase and alanine transaminase (SGPT) ≤ 2.5 X ULN, Albumin >2.5 mg/dL, International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants, Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants, An interval of >=12 weeks from the end of prior radiation therapy is required unless there is either: i) histopathologic confirmation of recurrent tumor, or ii) new enhancement on MRI outside of the radiation treatment field, An interval of >=3 weeks or 5 half-lives (whichever is longer) after the last administration of any investigational agent or any other treatment prior to first study dose, Female subjects of childbearing potential should have a negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Female subjects of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year. Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
- Serum creatinine ≤1.5 X upper limit of normal (ULN) OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≥ 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 2 years
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to treat glioblastoma, a type of brain cancer. The trial is divided into two groups, with the first group receiving the new combination of drugs to test for safety and the second group receiving the new combination of drugs as well as surgery.
Who is the study for?
Adults with first or second recurrence of glioblastoma, who've had radiation therapy and are suitable for tumor removal surgery. They must have a good performance status (able to carry out daily activities), adequate organ function, and agree to use birth control. Excluded are those on high steroid doses, prior immune checkpoint inhibitor treatment, known immunodeficiency or active hepatitis, other progressing cancers, active autoimmune disease requiring recent treatment, multifocal disease (Cohort B only), current serious infections or conditions that could affect trial participation.Check my eligibility
What is being tested?
The study tests AB154 combined with AB122 in patients with recurrent glioblastoma. It has two parts: Cohort A checks safety at specific dosages; Cohort B further evaluates safety and collects tissue/blood samples for research on how the drugs work within tumors. Participants will receive intravenous treatments of both drugs.See study design
What are the potential side effects?
Specific side effects aren't listed but may include typical reactions to cancer therapies such as fatigue, infusion-related reactions like fever or chills, potential organ inflammation due to immune response modification by the drugs being tested.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is within the normal range.
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I can carry out normal activities with minimal symptoms.
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My cancer has come back once or twice after treatment, which included radiation.
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My diagnosis is Grade IV glioblastoma.
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My hemoglobin level is above 9 g/dL without needing transfusions or EPO.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] associated with the combination AB122 and AB154 in patients with recurrent glioblastoma
Secondary outcome measures
Single cell RNA sequencing of tumor and blood after exposure to AB154 with and without AB122
Tregs and CD8 T cells ratio by immunofluorescence
Trial Design
5Treatment groups
Experimental Treatment
Group I: Placebo Surgical Cohort (Cohort B4)Experimental Treatment1 Intervention
Candidates for surgical resection will be enrolled and initiate study treatment approximately two weeks prior to the resection. The pre-surgical dose (neoadjuvant treatment) will be double-blinded.
B4 (N=10): Two placebo infusions
Following surgery, all patients will initiate treatment with the combination of AB154 and AB122. AB154 will be given at a dose of 10 mg/kg and AB122 will be given at a dose of 240 mg (flat).
Group II: AB154 Surgical Cohort (Cohort B1)Experimental Treatment2 Interventions
Candidates for surgical resection will be enrolled and initiate study treatment approximately two weeks prior to the resection. The pre-surgical dose (neoadjuvant treatment) will be double-blinded.
B1 (N=10): AB154 single agent (10 mg/kg) + placebo
Following surgery, all patients will initiate treatment with the combination of AB154 and AB122. AB154 will be given at a dose of 10 mg/kg and AB122 will be given at a dose of 240 mg (flat).
Group III: AB154 + AB122 Surgical Cohort (Cohort B3)Experimental Treatment2 Interventions
Candidates for surgical resection will be enrolled and initiate study treatment approximately two weeks prior to the resection. The pre-surgical dose (neoadjuvant treatment) will be double-blinded.
B3 (N=10): AB154 (10 mg/kg) +AB122 (240 mg)
Following surgery, all patients will initiate treatment with the combination of AB154 and AB122. AB154 will be given at a dose of 10 mg/kg and AB122 will be given at a dose of 240 mg (flat).
Group IV: AB122 Surgical Cohort (Cohort B2)Experimental Treatment2 Interventions
Candidates for surgical resection will be enrolled and initiate study treatment approximately two weeks prior to the resection. The pre-surgical dose (neoadjuvant treatment) will be double-blinded.
B2 (N=10): AB122 single agent (240 mg) + placebo
Following surgery, all patients will initiate treatment with the combination of AB154 and AB122. AB154 will be given at a dose of 10 mg/kg and AB122 will be given at a dose of 240 mg (flat).
Group V: AB122 + AB154 Safety Cohort (Cohort A)Experimental Treatment2 Interventions
Eligible patients will be sequentially enrolled to receive intravenous AB154 combined with AB122 (N=6). AB154 will be given at a dose of 10 mg/kg and AB122 will be given at a dose of 240 mg (flat).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,852 Previous Clinical Trials
2,738,395 Total Patients Enrolled
2 Trials studying Glioblastoma
23 Patients Enrolled for Glioblastoma
Arcus Biosciences, Inc.Industry Sponsor
41 Previous Clinical Trials
6,020 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,808 Total Patients Enrolled
322 Trials studying Glioblastoma
23,069 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently being treated for an infection.My kidney function is within the normal range.I can carry out normal activities with minimal symptoms.I have not received a live vaccine within the last 30 days.My organs and bone marrow are functioning well.My neurosurgeon considers me a candidate for surgery to remove as much of the tumor as possible.I am not pregnant, will use birth control, and if male, will also use contraception during the study.My condition involves cancer in multiple locations.I have an active tuberculosis infection.I have been treated with bevacizumab.My cancer has come back once or twice after treatment, which included radiation.My blood clotting time is normal or near normal, or controlled if I'm on blood thinners.My diagnosis is Grade IV glioblastoma.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.My hemoglobin level is above 9 g/dL without needing transfusions or EPO.My neurosurgeon has approved me for surgery to remove as much of the tumor as possible.I have recovered from side effects of previous treatments, except for hair loss and tiredness.I need high doses of steroids to manage my condition.It's been 12 weeks since my last radiation, or I have confirmed tumor recurrence or new growth outside the treated area.I have another cancer besides skin or in situ cervical cancer that needs treatment.I have a history of or currently have non-infectious lung inflammation.I am 18 years old or older.I am currently or have previously been treated with drugs that boost the immune system.I have been diagnosed with an immunodeficiency condition, such as HIV/AIDS.I have active Hepatitis B or C.My blood clotting time is normal or near normal, even if I'm on blood thinners.It has been over 3 weeks or 5 half-lives since my last treatment before starting the study.
Research Study Groups:
This trial has the following groups:- Group 1: AB122 + AB154 Safety Cohort (Cohort A)
- Group 2: AB154 Surgical Cohort (Cohort B1)
- Group 3: AB122 Surgical Cohort (Cohort B2)
- Group 4: AB154 + AB122 Surgical Cohort (Cohort B3)
- Group 5: Placebo Surgical Cohort (Cohort B4)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what degree has the recruitment process for this clinical trial been successful?
"Affirmative. Information available on clinicaltrials.gov attests that this trial is actively seeking participants, which first appeared online on April 21st 2021 and was recently updated on July 5th 2022. At present, 46 patients are needed from one medical centre for enrolment in the study."
Answered by AI
Are there any available vacancies in this clinical trial?
"Correct. The information hosted on clinicaltrials.gov shows that this medical trial, initially announced April 21st 2021, is actively enrolling patients. 46 participants are needed to be recruited from 1 distinct location."
Answered by AI
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