A Phase 1 interventional study of AB598 and Zimberelimab in Advanced Cancer, Advanced Malignancies and Bladder Cancer, sponsored by Arcus Biosciences, Inc.. Active, not recruiting at 19 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Arcus Biosciences, Inc. · Phase 1, Interventional, and Treatment
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Among 881 studies in Urinary Bladder Neoplasms with a site in United States — 162 open to participants now, 267 under way, 31 of them phase 3. Urinary Bladder Neoplasms · United States.
Among the 881 studies in Urinary Bladder Neoplasms with a site in United States, this one is the 385th largest by enrollment of the 714 interventional ones that give a count, is one of 42 that started in 2023, is one of 198 in phase 1, reaches primary completion later than 145 of the 264 other live ones, and was the 734th registered.
1,800 studies on the registry are indexed under Urinary Bladder Neoplasms; 446 are open to participants now.
Browse Urinary Bladder Neoplasms studies →162 of the 881 studies in Urinary Bladder Neoplasms with a site in United States are open now. Recruiting first, the newest first:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Sites in United States
Ages 18+
SystImmune Inc. · Sites in United States
Ages 18+
Fred Hutchinson Cancer Center · Sites in United States
Ages 18+
Fox Chase Cancer Center · Sites in United States
Ages 18+
Dana-Farber Cancer Institute · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 336 Urinary Bladder Neoplasms studies recruiting now, 256 (76%) set no upper age limit and 22 (7%) stop at 75 or younger; 22 take children under 18; 21 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
881 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 281 · Phase 2 329 · Phase 3 88 · Phase 4 7
First in 1988; this study’s year is marked. 42 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 40 is below the median of 60 across 1,296 interventional studies indexed under Urinary Bladder Neoplasms.
Median enrollment 46 across the 714 interventional studies, 180 across the 144 observational. Of the 562 that completed or were terminated, 253 (45%) have results posted.
This tab as a report to print or save as PDF → With an account.
313 of 881 have an industry lead sponsor. The 10 most frequent:
Arcus Biosciences, Inc. is the lead sponsor of 32 studies on the registry; 4 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Arcus Biosciences, Inc. has 2 studies filed under Urinary Bladder Neoplasms — fewer than ten, so there is no comparison to draw.
98 of the studies in Urinary Bladder Neoplasms with a site in United States that are under way reach primary completion within a year, 6 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06111235Phase 3CG Oncology, Inc.A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT | 2026-11 |
| NCT04658862Phase 3Janssen Research & Development, LLCA Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder | 2026-12-30 |
| NCT06525571Phase 3Johns Hopkins UniversityOutcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection | 2027-01-04 |
| NCT05911295Phase 3Seagen, a wholly owned subsidiary of PfizerDisitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2 | 2027-01-29 |
| NCT04241185Phase 3Merck Sharp & Dohme LLCEfficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Muscle-invasive Bladder Cancer (MIBC) (MK-3475-992/KEYNOTE-992) | 2027-01-31 |
Add all 98 to your calendar (.ics) → With an account.
Among the 881 studies in Urinary Bladder Neoplasms with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The primary purpose of this study is to assess the safety and tolerability of AB598 in participants with advanced malignancies.
Key Inclusion Criteria:
Monotherapy-specific criteria for dose escalation and PD cohorts:
Dose Expansion cohort criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive AB598 intravenous (IV) infusion once every 3 weeks
Drug: AB598
Participants will receive AB598 IV infusion once every 3 weeks
Drug: AB598
Participants will receive AB598 IV infusion once every 3 weeks
Drug: AB598
Participants will receive AB598 IV infusion once every 3 weeks
Drug: AB598
Participants will receive AB598 IV infusion once every 3 weeks
Drug: AB598
Participants will receive AB598 IV infusion once every 3 weeks
Drug: AB598
Participants will receive AB598 IV infusion once every 3 weeks
Drug: AB598
Participants will receive AB598 IV infusion every 2 weeks in combination with zimberelimab and FOLFOX (oxaliplatin, leucovorin, fluorouracil)
Drug: AB598 · Drug: Zimberelimab · Drug: Fluorouracil · Drug: Leucovorin · Drug: Oxaliplatin
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Also known as: AB122
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 2 years
Dose Escalation Cohorts: Number of Participants with Dose-Limiting Toxicities (DLTs)
Time frame: Up to 2 years
Area Under the Concentration-Time Curve from Administration ("0") to the Time That the Drug is No Longer Present in the Body ("infinity") (AUC 0-inf) in Whole Blood and Plasma
Time frame: Predose, Up to 4 hours post dose
Maximum Concentration (Cmax) in Whole Blood and Plasma
Time frame: Predose, Up to 4 hours post dose
Time to Maximum Concentration (Tmax) in Whole Blood and Plasma
Time frame: Predose, Up to 4 hours post dose
Number of Participants Who Test Positive for Antidrug Antibodies (ADAs) to AB598
Time frame: Up to 2 years
Objective Response Rate (ORR)
Time frame: Up to 2 years
Dose Expansion Cohort: Duration of Response (DOR)
Time frame: Up to 2 years
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Data sharing details ↗ · trials.arcusbio.com
Started Oct 2023 (actual). Primary completion is estimated for Sep 2027, 47 months after the start.
Of 80 industry-sponsored phase 1 interventional studies under Urinary Bladder Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 66. This study's planned 47 months is close to that.
Counting every sponsor, half of 145 studies reached it within 43 months; a quarter within 29 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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