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id="header-search--input" name="q" type="text" class="form-control form-control-sm" placeholder="Search UCSF clinical trials" title="Search clinical trials at UCSF"> <input class="sr-only form-control-sm btn btn-sm btn-secondary" type="submit" value="Search trials"> </form></div></div> </nav></header><main id="content" class="mx-1 mx-md-0"> <div class="container-xl px-5"><div class="row"><div class="col-md-9 col-lg-8" role="main" id="main-column"><div id="summary" class="page-header show-jargon-definitions"><h1 id="summary--title"> AB154 Combined With AB122 for Recurrent Glioblastoma </h1><p class="h3 hide-long-content">a study on <span class="comma-list"><span class="comma-list-item"> <a href="../astrocytoma">Astrocytoma</a></span><span class="comma-list-item"> <a href="../glioblastoma">Glioblastoma</a></span><span class="comma-list-item"> <a href="../glioma">Glioma</a></span></span></p></div><div id="trial-details-container"><div id="key-points" class="trial-details-block"><div class="row"> <div class="col"><h2 class="sr-only h3">Summary</h2><dl id="key-points-bullets" class="row"><dt class="d-none d-sm-block col-sm-1 col-lg-2"> <i class="fa fa-user fa-lg fa-fw" aria-hidden="true"></i> <span class="sr-only">Eligibility</span></dt><dd class="col-12 col-sm-11 col-lg-10"> <strong>for people ages 18 years and up</strong> (<a href="#eligibility">full criteria</a>) </dd><dt class="d-none d-sm-block col-sm-1 col-lg-2"> <i class="fa fa-map-marker fa-lg fa-fw" aria-hidden="true"></i> <span class="sr-only">Location</span></dt><dd class="col-12 col-sm-11 col-lg-10"> <a href="#location"> at San Francisco, California and other locations </a> </dd><dt class="d-none d-sm-block col-sm-1 col-lg-2"> <i class="fa fa-calendar fa-lg fa-fw" aria-hidden="true"></i> <span class="sr-only">Dates</span></dt><dd class="col-12 col-sm-11 col-lg-10"><div> study started <span itemscope itemtype="https://schema.org/WebPage"><time itemprop="dateCreated" datetime="2021-04-21">April 2021</time></span></div><div> completion around <time datetime="2025-12-31">December 2025</time></div><div itemscope itemtype="https://schema.org/WebPage" aria-hidden="true" class="d-none"><meta itemprop="datePublished" content="2020-12-07"></div></dd><dt class="d-none d-sm-block col-sm-1 col-lg-2"> <i class="fa fa-user-md fa-lg fa-fw" aria-hidden="true"></i> <span class="sr-only">Principal Investigator</span></dt><dd class="col-12 col-sm-11 col-lg-10 comma-list"> by <span class="pi-name comma-list-item"><span><a href="https://profiles.ucsf.edu/nicholas.butowski" target="_blank" rel="noopener author" class="trial--link-to-pi-profile">Nicholas Butowski, MD</a></span></span></dd></dl></div> <div class="d-none d-md-block col-md-auto" id="pi-photos-block"><figure class="figure"><img class="pi-photo figure-img img-fluid rounded" src="https://researcherprofiles.org/profile/Modules/CustomViewPersonGeneralInfo/PhotoHandler.ashx?NodeID=188317" alt="Headshot of Nicholas Butowski" loading="lazy"><figcaption class="figure-caption">Nicholas Butowski</figcaption></figure></div></div></div><div id="description" class="trial-details-block"><h2 class="h3">Description</h2><div class="show-jargon-definitions"><h3 class="h4">Summary</h3><div class="hide-long-content"><p>This is a phase 0/I exploratory study. Patients at first or second recurrence of <a href="../glioblastoma" class="trial--link-to-condition-in-text">glioblastoma</a> will be enrolled. The study will be divided into two cohorts: Cohort A (safety cohort) and Cohort B (surgical patient cohort).</p><p>Cohort A: 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).</p><p>Cohort B: Expansion surgical cohort. The purpose of cohort B is to provide an additional safety evaluation of AB154 + AB122 as well as tissue and blood for exploratory ancillary studies investigating the effects of AB154 + AB122 in the tumor and tumor microenvironment. A total of 40 patients will be enrolled in this cohort.</p></div><h3 class="h4">Official Title</h3><p class="hide-long-content">A Multi-Center Phase 0/I Trial of Anti-TIGIT Antibody AB154 in Combination With Anti-PD-1 Antibody AB122 for Recurrent Glioblastoma.</p><h3 class="h4">Details</h3><div class="hide-long-content"><p>This is a phase 0/I exploratory study. Patients at first or second recurrence of <a href="../glioblastoma" class="trial--link-to-condition-in-text">glioblastoma</a> will be enrolled. The study will be divided into two cohorts: Cohort A (safety cohort) and Cohort B (surgical patient cohort).</p><p>Cohort A: 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).</p><p>Cohort B: Expansion surgical cohort. The purpose of cohort B is to provide an additional safety evaluation of AB154 + AB122 as well as tissue and blood for exploratory ancillary studies investigating the effects of AB154 + AB122 in the tumor and tumor microenvironment. A total of 40 patients will be enrolled in this cohort.</p><p>Following completion of cohort A, patients who are candidates for surgical resection for management of tumor progression (i.e. need for diagnostic confirmation or tumor debulking) will be enrolled prior to surgical resection, and initiate study treatment approximately two weeks prior to the resection.</p><p>Patients will be randomized to one of the four treatment arms and initiate treatment prior to surgery, according to treatment assignment.</p><p>The pre-surgical dose (neoadjuvant treatment) will be double-blinded. A total of 10 patients will be allocated to each one of the following groups in a blinded fashion, approximately two weeks before surgery:</p><ul><li> B1 (N=10): AB154 single agent (10 mg/kg) + placebo</li><li> B2 (N=10): AB122 single agent (240 mg) + placebo</li><li> B3 (N=10): AB154 (10 mg/kg) +AB122 (240 mg)</li><li> B4 (N=10): Two placebo infusions</li></ul><p>Following surgery, all patients (N=40) will initiate treatment with the combination of AB154 and AB122.</p></div><h3 class="h4">Keywords</h3><p class=" hide-long-content"><span> <a href="../glioblastoma" class="trial--link-to-condition-in-text">Glioblastoma</a></span>, <span> Recurrent</span>, <span> PD1</span>, <span> TIGIT</span>, <span> <a href="../immunotherapy" class="trial--link-to-condition-in-text">Immunotherapy</a></span></p></div></div><div id="eligibility" class="trial-details-block show-jargon-definitions"><h2 class="h3">Eligibility</h2><div class="hide-long-content"><div class="row"><div class="col-12 col-lg-6"><h3 class="h4 mt-0"> <i class="fa fa-check-square-o" aria-hidden="true"></i> You can join if… </h3><div><p><strong>Open to people ages 18 years and up</strong></p><ol><li>Grade IV glioma (glioblastoma and its variants according to the World Health Organization 2021), confirmed in tissue at time of initial diagnosis. Tumors with an IDH 1 or 2 mutation are excluded. Sequencing of IDH 1 and 2 is not required but, at a minimum, a negative result for the presence of IDH-1 R132H mutation on IHC is required for eligibility.</li><li>First or second recurrence after treatment. Prior treatment must include at least radiation therapy.</li><li>Measurable contrast enhancing tumor by Response Assessment in Neuro-Oncology (RANO) criteria. Tumors with an IDH 1 or 2 mutation are excluded. Sequencing of IDH 1 and 2 is not required but, at a minimum, a negative result for the presence of IDH-1 R132H mutation on IHC is required for eligibility.</li><li>Age ≥18 years.</li><li>Karnofsky performance status ≥70</li><li>Patients must have adequate organ and marrow function as defined below within 14 days of treatment <ul><li> Absolute neutrophil count (ANC) ≥1,500 /mcL</li><li> Platelets ≥100,000 / mcL</li><li> Hemoglobin ≥9 g/dL or ≥ 5.6 mmol/L without transfusion or Erythropoietin (EPO) dependency (within 7 days of assessment)</li><li> 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</li><li> Serum total bilirubin ≤ 1.5 X ULN OR direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN</li><li> aspartate aminotransferase and alanine transaminase (SGPT) ≤ 2.5 X ULN</li><li> Albumin >2.5 mg/dL</li><li> 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</li><li> 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</li></ul></li><li>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.</li><li>An interval of >=4 weeks or 5 half-lives (whichever is shorter) after the last administration of any investigational agent or any other treatment prior to first study dose.</li><li>Female subjects of childbearing potential should have a negative urine or serum <a href="../pregnancy" class="trial--link-to-condition-in-text">pregnancy</a> 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 <a href="../contraception" class="trial--link-to-condition-in-text">contraception</a> starting with the first dose of study therapy through 120 days after the last dose of study therapy.</li><li>Ability to understand and the willingness to sign a written informed consent document.</li></ol><p> ADDITIONAL CRITERIA FOR COHORT B</p><ol><li>Deemed a candidate for tumor debulking, as determined by the neurosurgeon.</li></ol></div></div><div class="col-12 col-lg-6"><h3 class="h4 mt-0"> <i class="fa fa-ban" aria-hidden="true"></i> You CAN'T join if... </h3><div><ol><li>Patients who have been treated with bevacizumab. Note: Previous use of intra-arterial bevacizumab may be allowed, contingent upon review and approval by study principal investigator and sponsor.</li><li>Patients who have not recovered from adverse events due to prior therapy (i.e. >Grade 1) with the exception of <a href="../alopecia" class="trial--link-to-condition-in-text">alopecia</a> and fatigue.</li><li>Patients with multifocal disease. (Cohort B only)</li><li>Subjects requiring escalating or chronic supraphysiologic doses of corticosteroids (> 10 mg/d of prednisone equivalent or > 2 mg dexamethasone) for control of disease at the time of registration.</li><li>Patients receiving previous or current treatment with an immune checkpoint inhibitor.</li><li>Patients with a known diagnosis of immunodeficiency, including Human Immunodeficiency Virus (HIV) or acquired immunodeficiency syndrome (AIDS).</li><li>Has known active <a href="../hepatitis-b" class="trial--link-to-condition-in-text">Hepatitis B</a> (e.g., Hepatitis B surface antigen reactive) or Hepatitis C (e.g., <a href="../hepatitis-c" class="trial--link-to-condition-in-text">Hepatitis C Virus</a> RNA [qualitative] is detected)</li><li>Has a known history of active tuberculosis (Bacillus Tuberculosis).</li><li>Has a known additional malignancy that is progressing or requires active treatment. Exceptions include <a href="../basal-cell-carcinoma" class="trial--link-to-condition-in-text">basal cell carcinoma</a> of the skin or <a href="../squamous-cell-carcinoma" class="trial--link-to-condition-in-text">squamous cell carcinoma</a> of the skin that has undergone potentially curative therapy or in situ <a href="../cervical-cancer" class="trial--link-to-condition-in-text">cervical cancer</a>.</li><li>Has active <a href="../autoimmune-disease" class="trial--link-to-condition-in-text">autoimmune disease</a> that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.</li><li>Has known history of, or any evidence of active, non-infectious pneumonitis.</li><li>Has an active infection requiring systemic therapy.</li><li>Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.</li><li>Has known psychiatric or <a href="../substance-abuse" class="trial--link-to-condition-in-text">substance abuse</a> disorders that would interfere with cooperation with the requirements of the trial.</li><li>Is pregnant or <a href="../breastfeeding" class="trial--link-to-condition-in-text">breastfeeding</a> or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.</li><li>Unable to undergo MRI of the brain with and without contrast enhancement (i.e. pacemaker, allergy to MRI contrast agent or any other contraindication for MRIs).</li><li>Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.</li></ol></div></div></div></div></div><div id="location" class="trial-details-block"><h2 class="h3">Locations</h2><ul id="locations-list" class="hide-long-content "><li class="location location-is-institutional" itemprop="address" itemscope itemtype="https://schema.org/PostalAddress"><span class="location-name" itemprop="name">UCSF</span><wbr> <span class="badge badge-secondary">accepting new patients</span><br><span class="location-address comma-list comma-list--without-and"><span class="comma-list-item" itemprop="addressLocality"> San Francisco</span><span class="comma-list-item" itemprop="addressRegion"> California</span><span class="comma-list-item" itemprop="postalCode"> 94143</span><span class="comma-list-item" itemprop="addressCountry"> United States</span></span></li><li class="location " itemprop="address" itemscope itemtype="https://schema.org/PostalAddress"><span class="location-name" itemprop="name">Yale University</span><wbr> <span class="badge badge-secondary">accepting new patients</span><br><span class="location-address comma-list comma-list--without-and"><span class="comma-list-item" itemprop="addressLocality"> New Haven</span><span class="comma-list-item" itemprop="addressRegion"> Connecticut</span><span class="comma-list-item" itemprop="postalCode"> 06519</span><span class="comma-list-item" itemprop="addressCountry"> United States</span></span></li><li class="location " itemprop="address" itemscope itemtype="https://schema.org/PostalAddress"><span class="location-name" itemprop="name">Dana Farber Cancer Institute</span><wbr> <span class="badge badge-secondary">accepting new patients</span><br><span class="location-address comma-list comma-list--without-and"><span class="comma-list-item" itemprop="addressLocality"> Boston</span><span class="comma-list-item" itemprop="addressRegion"> Massachusetts</span><span class="comma-list-item" itemprop="postalCode"> 02215</span><span class="comma-list-item" itemprop="addressCountry"> United States</span></span></li></ul></div><div id="pis" class="trial-details-block"><h2 class="h3">Lead Scientist <span class="d-none d-sm-inline">at UCSF</span></h2><ul class="pis-list--only-one-pi"><li class="pi"><span class="pi-name"> <strong> <a href="https://profiles.ucsf.edu/nicholas.butowski" target="_blank" rel="noopener author" class="trial--link-to-pi-profile">Nicholas Butowski, MD</a> </strong> </span><br> Dr. Nicholas Butowski is a neuro-oncologist who specializes in brain tumors, neuroimaging, cognitive and rehabilitative neurology, and complementary therapies for neurological disorders. He is director of clinical services in neuro-oncology and a researcher at the Brain Tumor Center. </li></ul></div><div id="details" class="trial-details-block"><h2 class="h3">Details</h2><dl class="row"><dt class="col-sm-3 text-sm-right">Status</dt><dd class="col-sm-9"> accepting new patients </dd><dt class="col-sm-3 text-sm-right">Start Date</dt><dd class="col-sm-9"><time datetime="2021-04-21">April 2021</time></dd><dt class="col-sm-3 text-sm-right">Completion Date</dt><dd class="col-sm-9"><time datetime="2025-12-31">December 2025</time> (estimated)</dd><dt class="col-sm-3 text-sm-right">Sponsor</dt><dd class="col-sm-9">Yale University</dd><dt class="col-sm-3 text-sm-right">ID</dt><dd class="col-sm-9"> <a href="https://clinicaltrials.gov/ct2/show/NCT04656535" class="trial--link-to-clinicaltrials-gov" target="_blank" rel="noopener nofollow" title="ClinicalTrials.gov identifier">NCT04656535</a> </dd><dt class="col-sm-3 text-sm-right">Phase</dt><dd class="col-sm-9">Phase 1 research study</dd><dt class="col-sm-3 text-sm-right">Study Type</dt><dd class="col-sm-9">Interventional</dd><dt class="col-sm-3 text-sm-right">Participants</dt><dd class="col-sm-9">Expecting 46 study participants</dd><dt class="col-sm-3 text-sm-right">Last Updated</dt><dd class="col-sm-9"><span itemscope itemtype="https://schema.org/WebPage"><time itemprop="dateModified" datetime="2024-07-17">July 2024</time></span></dd></dl></div><div id="faq" class="trial-details-block d-print-none" role="complementary"><h2 class="h3">Frequently Asked Questions</h2><ul><li><a href="../about/how-clinical-trials-work">How Do Clinical Trials Work?</a></li><li><a href="../about/what-to-expect">What to Expect</a></li><li><a href="../about/who-can-join">Who Can Join</a></li><li><a href="../about/our-researchers">Our Researchers</a></li></ul></div><div class="text-center my-3"> <a href="#" id="contact-button-end" class="btn btn-primary btn-lg d-none d-md-inline" data-toggle="modal" data-target="#contact-modal" aria-description="Are you interested? Contact us to learn more about joining this clinical trial"> <i class="fa fa-envelope mr-2" aria-hidden="true"></i> Contact us about this trial </a> </div></div> </div><div class="col-md-3 text-center offset-lg-1 d-none d-md-block d-print-none" id="secondary-column"> <div id="sidebar"> <a href="#" id="contact-button-sidebar" class="animated zoomIn btn btn-lg btn-block btn-primary mb-4" data-toggle="modal" data-target="#contact-modal" aria-description="Are you interested? 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Contact us to learn more about joining this clinical trial"> I’m interested in this study! </a> </div> <div class="modal fade" id="contact-modal" tabindex="-1" role="dialog" aria-labelledby="contact-modal-label" aria-hidden="true"><div class="modal-dialog modal-dialog-scrollable" role="document"><div class="modal-content"><div class="modal-header"><h4 class="modal-title h5" id="contact-modal-label">Please contact me about this study</h4> <button type="button" class="close" data-dismiss="modal" aria-label="Close"> <span aria-hidden="true">×</span> </button> </div><div class="modal-body"> <form id="contact-form" class="form-horizontal" action="https://clinicaltrials.ucsf.edu/action/trial-contact/" method="POST"> <input type="hidden" name="Trial_NCT" value="NCT04656535"> <input type="hidden" name="Trial_Title" value="AB154 Combined With AB122 for Recurrent Glioblastoma"> <input type="hidden" name="Trial_Contact" value="53616c7465645f5f0a141e28323c4650292a4622e0d8c04d456affd6b3d6c25833f4bf2c9406fd8831fbc7a9e7e1c1a2f090e561e66104b0bb2d596a186e07a5"> <div class="form-group row"> <label class="col-sm-3 col-form-label col-form-label-lg text-sm-right" for="contact-name">Name</label> <div class="col-sm-8 form-group--input-container"> <input name="Name" type="text" class="form-control form-control-lg" id="contact-name" placeholder="Your name" required pattern=".*\w\w.*" minlength="2" autocomplete="name"> </div></div><div class="form-group row"> <label class="col-sm-3 col-form-label col-form-label-lg text-sm-right" for="contact-email">Email</label> <div class="col-sm-8 form-group--input-container"> <input name="Email" type="email" class="form-control form-control-lg" id="contact-email" placeholder="Your email" required data-error="Invalid email address" autocomplete="email"> <div id="contact-email--suggestion" class="d-none small"> You typed <span id="contact-email--suggestion-original" class="text-monospace text-info font-weight-bold"></span>. Did you mean <span id="contact-email--suggestion-email" class="text-monospace text-info font-weight-bold"></span>? </div></div></div><div class="form-group row"> <label class="col-sm-3 col-form-label col-form-label-lg text-sm-right" for="contact-phone">Phone</label> <div class="col-sm-8 form-group--input-container"> <input name="Phone" type="tel" class="form-control form-control-lg" id="contact-phone" placeholder="Your phone (optional)" pattern=".*\d.*\d.*\d.*\d.*\d.*\d.*\d.*\d.*" minlength="8" autocomplete="tel"> </div></div><div class="form-group row"> <label class="col-sm-3 col-form-label col-form-label-lg text-sm-right">Are you human?</label> <div class="col-sm-8 form-group--input-container"><div class="g-recaptcha" id="contact-recaptcha-captcha" data-sitekey="6LfpryUTAAAAAKT_A9vSYllUZW9fS3l-SzN_dzU2"></div><p class="small mb-0">This step makes sure spammers don’t flood our inbox</p></div></div><div class="form-group row"><div class="offset-sm-3 col-sm-8"> <button type="submit" class="btn btn-primary btn-lg">Send to study team</button> </div></div></form><p class="small">We will not share your information with anyone other than the team in charge of this study, which might include an external sponsor. Submitting your contact information does not obligate you to participate in research.</p></div> </div></div></div><div class="modal fade" id="contact-thank-you-modal" tabindex="-1" role="dialog" aria-hidden="true" aria-labelledby="contact-modal-label"><div class="modal-dialog" role="document"><div class="modal-content"><div class="modal-header"> <button type="button" class="close" data-dismiss="modal"><span aria-hidden="true">×</span><span class="sr-only">Close</span></button> <h4 class="modal-title h5" id="contact-thank-you-modal-label">Thank you!</h4></div><div class="modal-body"><p>The study team should get back to you in a few business days.</p><p>You will also receive an email with next steps. Check your junk/spam folder if needed.</p><p>If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT04656535.</p></div><div class="modal-footer"> <button type="button" class="btn btn-primary" data-dismiss="modal">OK</button> </div></div></div></div> <script type="application/ld+json"> [{"@context":"https://schema.org/","@type":"MedicalTrial","additionalType":"Product","alternateName":"A Multi-Center Phase 0/I Trial of Anti-TIGIT Antibody AB154 in Combination With Anti-PD-1 Antibody AB122 for Recurrent Glioblastoma.","code":{"@type":"MedicalCode","codeValue":"NCT04656535","codingSystem":"ClinicalTrials.gov"},"description":"This is a phase 0/I exploratory study. Patients at first or second recurrence of glioblastoma will be enrolled. The study will be divided into two cohorts: Cohort A (safety cohort) and Cohort B (surgical patient cohort). 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