Symptoms and General Pathology

All Conditions

Neoplasms

Rare Diseases

Recurrence

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunomodulating Agents

Immunoglobulins

Immunoglobulin G

Immunoglobulins, Intravenous

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).

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).

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).

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).

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).

AB122 is a fully human immunoglobulin G4 (hIgG4) monoclonal antibody (mAb) that targets PD-1 immune checkpoint.

AB122

AB154 is a humanized immunoglobulin G1 (IgG1) monoclonal antibody that targets TIGIT immune checkpoint.

AB154

Saline placebo comparator for pre-surgery treatment in cohort B4

Placebo

Tara McPartland

Stephanie Lewis

Nicholas Butowski, MD

Adam Blanchard

Nicholas Blondin, MD

Alyssa Russ

Amanda Spearman

Patrick Wen, MD

Joachim Baehring, MD

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).

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).

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.

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).

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).

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.

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.

Patients will be randomized to one of the four treatment arms and initiate treatment prior to surgery, according to treatment assignment.

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:

* B1 (N=10): AB154 single agent (10 mg/kg) + placebo
* B2 (N=10): AB122 single agent (240 mg) + placebo
* B3 (N=10): AB154 (10 mg/kg) +AB122 (240 mg)
* B4 (N=10): Two placebo infusions

Following surgery, all patients (N=40) will initiate treatment with the combination of AB154 and AB122.

After the initial safety cohort confirms the safety of the dosing schedule an expansion surgical cohort will be enrolled and this cohort will be randomized to one of four treatment arms for the first cycle prior to surgery,

Masking will only occur in the surgical cohort B (4 arms) during the first cycle prior to surgery. The masking will be removed after surgery and all patients will receive open label treatment with both AB122 and AB154.

AB154 Combined With AB122 for Recurrent Glioblastoma

A Multi-Center Phase 0/I Trial of Anti-TIGIT Antibody AB154 in Combination With Anti-PD-1 Antibody AB122 for Recurrent Glioblastoma.

Adverse events will be listed individually by patient and treatment group. The number of patients experiencing each adverse event will be summarized by organ and grade. The number and percentage of patients with adverse events in the different categories will be summarized by treatment group.

Pharmacodynamic effects of each pre-surgery treatment will be evaluated with single-cell RNA sequencing of tumor and blood to determine effects of each intervention on the immune response.

Resected tumors in cohorts B1 to 4 will be analyzed utilizing immunofluorescence for the ratio between Tregs and CD8 T cells, calculated by counting cells that are positive for a FoxP3 or a CD8 staining.

Arcus Biosciences, Inc.

National Cancer Institute (NCI)

Yale University

Professor of Neurology and of Neurosurgery

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Digestive System Diseases

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Gland and Hormone Related Diseases

Uterine Cervical Neoplasms

Esophageal Neoplasms

Carcinoma

Breast Neoplasms

Triple Negative Breast Neoplasms

Carcinoma, Non-Small-Cell Lung

Stomach Neoplasms

Carcinoma, Squamous Cell

Carcinoma, Renal Cell

Lung Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Urinary Bladder Neoplasms

Squamous Cell Carcinoma of Head and Neck

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urogenital Neoplasms

Urologic Neoplasms

Urologic Diseases

Male Urogenital Diseases

Adenocarcinoma

Kidney Neoplasms

Kidney Diseases

Head and Neck Neoplasms

Breast Diseases

Skin Diseases

Esophageal Cancer

Ovarian Cancer

Renal Cell Carcinoma

Stomach Cancer

Ovarian Epithelial Cancer

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

Micronutrients

Hematinics

Vitamins

Oxaliplatin

Carboplatin

Leucovorin

Fluorouracil

Pemetrexed

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Enzyme Inhibitors

Folic Acid Antagonists

Folate

Vitamin B9

Folinic Acid

Participants will receive AB598 intravenous (IV) infusion once every 3 weeks

Participants will receive AB598 IV infusion once every 3 weeks

Participants will receive AB598 IV infusion in combination with zimberelimab and carboplatin/pemetrexed once every 3 weeks, for up to 2 years

Participants will receive AB598 IV infusion every 2 weeks in combination with zimberelimab once every 4 weeks, and FOLFOX (oxaliplatin, leucovorin, fluorouracil) every 2 weeks, for up to 2 years

Administered as specified in the treatment arm

AB598

Zimberelimab

Medical Director

The primary purpose of this study is to assess the safety and tolerability of AB598 when taken alone, and in combination with zimberelimab and standard chemotherapy in participants with advanced malignancies.

Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers

A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB598 Monotherapy and Combination Therapy in Participants With Advanced Malignancies

Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan \[SAP\], Clinical Study Report \[CSR\]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.

For more information, please visit our website.

Immune System Diseases

Prostatic Neoplasms

Hypersensitivity

Genital Neoplasms, Male

Genital Diseases

Genital Diseases, Male

Prostatic Diseases

Anti-Arrhythmia Agents

Vasodilator Agents

Analgesics

Hormones

Adenosine

Quemliclustat

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Subjects with metastatic prostate cancer will receive quemliclustat and etrumadenant for 4 weeks prior to metastasis-directed SBRT (Stereotactic Body Radiation Therapy). Within one week of completing SBRT, subjects will also start zimberelimab.

Etrumadenant

240 mg IV once every two weeks starting within 1 week of completing metastasis-directed SBRT

Standard of care metastasis-directed hypofractionated radiotherapy treatment starting 4 weeks (+/- 1 week) of starting Etrumadenant and Quemliclustat

Stereotactic Body Radiation Therapy

Catherine S. Spina, MD, PhD

Research Nurse Navigator

This study will evaluate the safety and effectiveness of a combination of study drugs including zimberelimab, etrumadenant, and quemliclustat in combination with metastasis-directed irradiation in men with hormone sensitive oligometastatic prostate cancer.

The study aims to test the hypothesis that targeted inhibition of the adenosine signaling axis (quemliclustat (CD73 antagonist) + etrumadenant (A2AR/A2BR antagonist)) and immune checkpoint inhibition (zimberelimab, α-PD-1) in combination with metastasis-directed stereotactic body radiation therapy (SBRT) will improve local control, progression-free survival (PFS), and hormone therapy-free survival and mitigate immunosuppressive changes to the tumor microenvironment (TME), compared to SBRT alone.

The optimal therapeutic approach to men with oligometastatic (1-3 or 1-5 sites of metastatic disease) prostate cancer is ever more important as advanced imaging technologies are becoming standard of care, providing clinicians with the tools to accurately diagnose and localize oligometastatic prostate cancer. Hence, methods to improve the local curative potential of stereotactic body radiation therapy (SBRT) is a timely and important opportunity. In addition, previous data suggest that the adenosine A2A pathway may be a particularly attractive avenue for intervention in the context of radiation, thus influencing multiple suppressive populations within the tumor microenvironment (TME).

Immunotherapy based on the PD-1/PD-L1 signaling axis is a mainstay of therapy across multiple types of malignancies. This study aims to evaluate the effectiveness of a PD-1 inhibitor (zimberelimab) in combination with a selective dual antagonist of A2aR and A2bR (etrumadenant) and an anti-CD73 (quemliclustat). Immune checkpoint inhibitors and targeted inhibitors of the adenosine signaling axis modulate the TME and aspects of the systemic immune system to overcome tumor-induced immune suppression and improve responses to therapy.

This study aims to determine the effect of etrumadenant, quemliclustat and zimberelimab \[experimental\] when given with ablative radiation (SBRT)\[standard of care\] on the oligoprogressive disease (hormone sensitive oligometastatic prostate cancer), defined by being free from radiographic progression of irradiated target metastases and PSA (prostate surface antigen) response at 6 months. PSA response, local control, progression-free survival (PFS), treatment response, ADT-free survival, time-to-pain, and safety and tolerability will also be measured. By employing a Simon Two-Stage design, the trial will test whether or not etrumadenant + quemliclustat and zimberelimab combined with ablative radiation (SBRT) will improve PFS compared to SBRT alone (ORIOLE).

Simon Two-Stage design: In the first stage, trial will enroll 14 patients. If two or more patients show progression at 6 months, the study is terminated at the end of stage I. However, if 13 of the 14 remain free from progressive disease at 6 months, then the study would move onto the second stage. In this stage, n=9 additional patients will be enrolled, for a total of 23 total. If 21 of the 23 patients remain progression-free at 6 months, then the null hypothesis is rejected, and we will consider the addition of quemliclustat, etrumadenant, and zimberelimab to SBRT worthy of further study.

Adenosine Signaling Modulation and Immune Checkpoint Inhibition With Hormone Sensitive Oligometastatic Prostate Cancer

Phase II Single Arm Study Testing SBRT, Adenosine Signaling Modulation (AB680, AB928), and Immune Checkpoint Inhibition (AB122) for Men With Hormone Sensitive Oligometastatic Prostate Cancer

Biochemical recurrence is defined as a 0.2 ng/ml increase in PSA above the post-SBRT PSA nadir. Patient will be followed until biochemical recurrence, death, or end of study, whichever comes first. Patients who are alive and biochemical recurrence free will be censored at the last PSA measurement date.

To estimate the proportion of men treated with quemliclustat + etrumadenant + zimberelimab + SBRT who are free from biochemical failure at 6-months.

Report the percentage of patients with PD, CR, PR, and SD based on CT imaging among patients treated with oligometastasis-directed SBRT + quemliclustat + etrumadenant + zimberelimab at 6-months.

Report the percentage of patients with PD, CR, PR, and SD based on nuclear bone scan among patients treated with oligometastasis-directed SBRT + quemliclustat + etrumadenant + zimberelimab at 6-months.

Report the percentage of patients with PD, CR, PR, and SD based on PSMA-PET scan among patients treated with oligometastasis-directed SBRT + quemliclustat + etrumadenant + zimberelimab at 6-months.

Quantify pain using a numeric 10-point scale using the Brief Pain Inventory (BPI) every 12 weeks from time of enrollment.

Catherine Spina

Assistant Professor of Radiation Oncology

All patients will receive SRF617 administered in combination with etrumadenant (AB928) and zimberelimab (AB122).

SRF617 is a fully human antibody designed to inhibit the enzymatic activity of CD39.

SRF617

Etrumadenant is an A2aR and A2bR antagonist.

etrumadenant

Zimberelimab is a fully human anti-PD-1 monoclonal antibody.

zimberelimab

Vienna Reichert, PhD

This trial will look at the safety and preliminary efficacy of SRF617 in combination with etrumadenant and zimberelimab in patients with metastatic castration-resistant prostate cancer (mCRPC).

This is a phase 2, open-label, safety and preliminary efficacy trial in patients with mCRPC using the combination of SRF617, etrumadenant (AB928), and zimberelimab (AB122).

Study of SRF617 With AB928 (Etrumadenant) and AB122 (Zimberelimab) in Patients With Metastatic Castration Resistant Prostate Cancer

A Phase 2 Trial of SRF617 in Combination With AB928 (Etrumadenant) and AB122 (Zimberelimab) in Patients With Metastatic Castration-Resistant Prostate Cancer

Response was defined as Prostate-Specific Antigen (PSA) decline of ≥ 50% (PSA50) and/or radiographic objective response of Complete Response (CR) or Partial Response (PR) per Prostate Cancer Working Group 3 (PCWG3) Criteria. The number of participants with response shows participants with any one or combination of these response types.

* CR: Disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to \< 10 millimeters (mm) in short axis
* PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum of diameters

An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious Adverse Events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

The number of participants achieving CR or PR by PCWG3 criteria is reported:

* CR: Disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to \< 10 millimeters (mm) in short axis
* PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum of diameters
* Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions from the smallest value on trial (including Baseline, if that is the smallest). The sum of diameters must also demonstrate an absolute increase of at least 5 mm. Or, the appearance of one or more lesions
* Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD

DOR was defined as the time from first documented response (PSA50 and/or CR/PR) to documented disease progression as determined by applicable disease criteria, or documented death due to any cause, whichever occured first.

DCR was defined as the percentage of participants with CR, PR, or SD lasting a minimum of 12 weeks by PCWG3 or PSA50 criteria.

PSA50 response is defined as a confirmed PSA decrease from Baseline of 50% or more based on 2 consecutive assessments measured 3 to 4 weeks apart.

PSA30 response is defined as a confirmed PSA decrease from Baseline of 30% or more based on 2 consecutive assessments measured 3 to 4 weeks apart.

Landmark PFS was defined as the percentage of participants who have not developed PFS events of death or documented disease progression as determined by applicable disease criteria.

Number of participants with SSEs per PCWG3 criteria, defined as symptomatic fracture, radiation or surgery to bone, or spinal cord compression, is reported.

Surface Oncology

Coherus Biosciences, Inc.

The Safety Analysis Set included all participants who received any amount of study drug. Also included is 1 participant who discontinued due to an adverse event prior receiving study drug.

SRF617 was administered in combination with etrumadenant and zimberelimab in 28-day cycles according to the following dosing schedule:

* SRF617 1400 mg IV every q2 weeks on Days 1 and 15
* Etrumadenant 150 mg orally daily
* Zimberelimab 480 mg IV q4 weeks on Day 1

SRF617 + Etrumadenant + Zimberelimab

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

The Safety Analysis Set included all participants who received any amount of study drug

This study was originally intended to be conducted in 2 stages (1 and 2); however, a strategic decision was made to terminate the study during Stage 1.

Hillary O'Kelly, Executive Director, Clinical Operations

The Response-Evaluable Analysis Set is defined as all participants at Baseline who received study drug and had at least 1 post-Baseline response assessment or who discontinued the treatment phase because of radiographic or symptomatic disease progression (including death caused by disease progression) within 6 weeks (+ 2 week window) of the first dose of study drug.

Number of Participants With Response

Number of Participants With Adverse Events (AEs)

Analysis was not performed as data were not collected for this outcome measure due to early study termination

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
AB154 Combined With AB122 for Recurrent Glioblastoma	NCT04656535	Glioblastoma	AB122 AB154 Placebo	18 Years -	Yale University
Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers	NCT05891171	Advanced Cancer Advanced Malign... Bladder Cancer Cervical Cancer Esophageal Canc... Gastric Cancer Gastroesophagea... Head and Neck S... Non-Small Cell ... Ovarian Cancer Renal Cell Carc... Triple Negative...	AB598 Zimberelimab Carboplatin Pemetrexed Fluorouracil Leucovorin Oxaliplatin	18 Years -	Arcus Biosciences, Inc.
Adenosine Signaling Modulation and Immune Checkpoint Inhibition With Hormone Sensitive Oligometastatic Prostate Cancer	NCT05915442	Oligometastatic...	Quemliclustat Etrumadenant Zimberelimab Stereotactic Bo...	18 Years - 99 Years	Columbia University
Study of SRF617 With AB928 (Etrumadenant) and AB122 (Zimberelimab) in Patients With Metastatic Castration Resistant Prostate Cancer	NCT05177770	Metastatic Cast... Prostate Cancer	SRF617 etrumadenant zimberelimab	18 Years -	Coherus Biosciences, Inc.
AB122 Platform Study	NCT04999761	Advanced or Met... Pancreatic Duct... Colorectal Canc... Non-small Cell ... Gastric Cancer Alveolar Soft P...	AB122 AB122 AB122 TAS-116 AB122 TAS-116 AB122 TAS-116 AB122 TAS-120 AB122 TAS-115 AB122 TAS-115 AB122 TAS-102 Ramucirumab AB122 TAS-102 Bevacizumab	18 Years -	Taiho Pharmaceutical Co., Ltd.
Study of SRF617 With AB928 (Etrumadenant) and AB122 (Zimberelimab) in Patients With Metastatic Castration Resistant Prostate Cancer	NCT05177770	Metastatic Cast... Prostate Cancer	SRF617 etrumadenant zimberelimab	18 Years -	Coherus Biosciences, Inc.
AB122 Platform Study	NCT04999761	Advanced or Met... Pancreatic Duct... Colorectal Canc... Non-small Cell ... Gastric Cancer Alveolar Soft P...	AB122 AB122 AB122 TAS-116 AB122 TAS-116 AB122 TAS-116 AB122 TAS-120 AB122 TAS-115 AB122 TAS-115 AB122 TAS-102 Ramucirumab AB122 TAS-102 Bevacizumab	18 Years -	Taiho Pharmaceutical Co., Ltd.

Spots Global Cancer Trial Database for ab122

Every month we try and update this database with for ab122 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ab122

Every month we try and update this database with for ab122 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ab122 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.