Advanced Solid TumorPhase 1ARC-12NCT04772989
A Study to Evaluate AB308 in Combination With AB122 in Participants With Advanced Malignancies
A Phase 1 study testing AB308 and Zimberelimab in people with Advanced Solid Tumor and Non Small Cell Lung Cancer (NSCLC), run by Arcus Biosciences, Inc. at 22 sites in 3 countries.
Trial summary
This is a Phase 1/1b, multicenter, open-label, dose-escalation, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and clinical activity of AB308 in combination with zimberelimab (AB122) in participants with advanced malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Non Small Cell Lung Cancer (NSCLC), Melanoma
- What is being tested?
- AB308 and Zimberelimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 22 sitesin 3 countries
- Study dates
- 19 Mar 2021to 25 Aug 2025
- 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
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Male or female participants ≥ 18 years of age (or age ≥ regionally approved age of consent for participation in investigational clinical studies) at the time of signing the informed consent.
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Adequate organ and marrow function
Who cannot join
- History of trauma or major surgery within 28 days prior to the first dose of study treatment.
- Prior treatment with an anti-TIGIT antibody.
- Any active or prior autoimmune disease that required treatment within 3 years of the first dose of study treatment.
- Prior chemotherapy, targeted small-molecule therapy, immunotherapy, or biologic agents, or use of other investigational drugs within 28 days before first dose of study treatment.
- Discontinued prior immunotherapy for immune related adverse events with a high severity.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
22 sites in 3 countries.
22 sites in 3 countries
United States15 sites
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Virginia Cancer Specialists
Fairfax, Virginia, 22033-1712
Goshen Health System
Goshen, Indiana, 46526
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
Mayo Clinic Jacksonville - PPDS
Jacksonville, Florida, 32224
UCLA Department of Medicine - Hematology/Oncology
Los Angeles, California, 90095
Norton Cancer Insititute-Downtown
Louisville, Kentucky, 40202
University of Wisconsin - Madison
Madison, Wisconsin, 53792
Tennessee Onocology - Nashville
Nashville, Tennessee, 37205
Columbia University Medical Center
New York, New York, 10032-3729
University of Oklahoma Peggy and Charles Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15240
Mayo Clinic Rochester
Rochester, Minnesota, 55905
START South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
START South Texas Accelerated Research Therapeutics - Mountain Region
West Valley City, Utah, 84119
Spain5 sites
Hospital Universitario Vall d'Hebron
Barcelona
Clínica Universidad de Navarra - Madrid
Madrid
Hospital Universitario 12 de Octubre
Madrid
START MADRID Hospital Unviersitario Fundacion Jimenez Diaz
Madrid
Clínica Universidad de Navarra
Pamplona
Poland2 sites
Specjalistyczna Praktyka Lekarska Slawomir Mandziuk
Lubin
Med-Polonia Sp. z o.o.
Poznan
About this study
Official title: A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB308 in Combination With AB122 in Participants With Advanced Malignancies
This is a Phase 1/1b, multicenter, open-label, dose-escalation, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and clinical activity of AB308 in combination with zimberelimab (AB122) in participants with advanced malignancies.
- Conditions
- Advanced Solid Tumor, Non Small Cell Lung Cancer (NSCLC), Melanoma, Cervical Cancer, Multiple Myeloma, Lymphoma, Non-Hodgkin
- Being tested
- AB308, Zimberelimab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Melanoma, Uterine Cervical Neoplasms, Multiple Myeloma, Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Stomach Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AB308Drug
Administered intravenously (IV) as specified in the treatment arm
ZimberelimabDrug
Also called AB122
Administered IV as specified in the treatment arm
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Q3W Cohorts | Experimental | Escalating doses of AB308 in combination with zimberelimab (360 mg) will be given every 3 weeks in participants with advanced malignancies. Receives: Drug: AB308; Drug: Zimberelimab |
| Dose Escalation Q4W Cohorts | Experimental | Escalating doses of AB308 in combination with zimberelimab (480 mg) will be given every 4 weeks in participants with advanced malignancies. Receives: Drug: AB308; Drug: Zimberelimab |
| Dose Escalation Q6W Cohort | Experimental | Selected dose of AB308 in combination with zimberelimab will be given every 6 weeks in participants with advanced malignancies. Receives: Drug: AB308; Drug: Zimberelimab |
| Dose Expansion Cohort 1 | Experimental | AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with in participants with locally advanced or metastatic NSCLC. Receives: Drug: AB308; Drug: Zimberelimab |
| Dose Expansion Cohort 2 | Experimental | AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with melanoma. Receives: Drug: AB308; Drug: Zimberelimab |
| Dose Expansion Cohort 3 | Experimental | AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with metastatic gastric, or gastroesophageal junction, or esophageal cancer. Receives: Drug: AB308; Drug: Zimberelimab |
| Dose Expansion Cohort 4 | Experimental | AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with cervical cancer. Receives: Drug: AB308; Drug: Zimberelimab |
| Dose Expansion Cohort 5 | Experimental | AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with hematological malignancies. Receives: Drug: AB308; Drug: Zimberelimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with Adverse Events
Measured: From first study treatment administration until up to 90 days after the last dose (Approximately 1 year)
Percentage of participants who experience a Dose Limiting Toxicity
Measured: From first study treatment administration through Day 21 (Q3W arm) or Day 28 (Q4W arm) or Day 42 (Q6W arm)
Secondary outcomes (7)
Serum concentration of AB308
Measured: Recorded at baseline (day 1 of cycle 1), during each of the first 5 cycles (each cycle is 21 days or 28 days or 42 days) and up to the first 16 cycles of treatment (up to 22 months), and 30 and 90 days post last dose (up to approximately 25 months)
Serum concentration of zimberelimab
Measured: Recorded at baseline (day 1 of cycle 1), during each of the first 5 cycles (each cycle is 21 days or 28 days or 42 days) and up to the first 16 cycles of treatment (up to 22 months), and 30 and 90 days post last dose (up to approximately 25 months)
Percentage of participants with anti-drug antibodies to AB308
Measured: Recorded at baseline (day 1 of cycle 1), during each of the first 5 cycles (each cycle is 21 days or 28 days or 42 days) and up to the first 16 cycles of treatment (up to 22 months), and 30 and 90 days post last dose (up to approximately 25 months)
Percentage of participants with anti-drug antibodies to zimberelimab
Measured: Recorded at baseline (day 1 of cycle 1), during each of the first 5 cycles (each cycle is 21 days or 28 days or 42 days) and up to the first 16 cycles of treatment (up to 22 months), and 30 and 90 days post last dose (up to approximately 25 months)
Percentage of participants with Objective Response
Measured: From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (up to approximately 3-5 years)
Duration of Response
Measured: From the date of first occurrence of a documented objective response to first documentation of disease progression or death from any cause, whichever occurs first (up to approximately 3-5 years)
Percentage of Participants with Disease Control (complete response, partial response, or stable disease) for >6 months
Measured: From study enrollment until disease progression or loss of clinical benefit (up to approximately 3-5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start19 Mar 2021
- Primary completion25 Aug 2025
- Study completion25 Aug 2025
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
- Sequential
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arcus Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Arcus Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772989
- Sponsor's protocol ID
- ARC-12
- Other IDs
- 2021-005589-16, 2024-511116-25-00
- Acronym
- ARC-12
- Status last verified
- Sep 2024
- First submitted
- 22 Feb 2021
- Last updated
- 28 Aug 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB308 in Combination With AB122 in Participants With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT04772989
- Acronym / sponsor ID
- ARC-12 / ARC-12
- Conditions
- Advanced Solid Tumor, Non Small Cell Lung Cancer (NSCLC), Melanoma, Cervical Cancer, Multiple Myeloma, Lymphoma, Non-Hodgkin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Arcus Biosciences, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Gilead Sciences
- Study start
- 19 Mar 2021 (actual)
- Primary completion
- 25 Aug 2025 (actual)
- Study completion
- 25 Aug 2025 (actual)
- First posted
- 26 Feb 2021 (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 is a Phase 1/1b, multicenter, open-label, dose-escalation, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and clinical activity of AB308 in combination with zimberelimab (AB122) in participants with advanced malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Q3W Cohorts | Experimental | Drug: AB308, Drug: ZimberelimabEscalating doses of AB308 in combination with zimberelimab (360 mg) will be given every 3 weeks in participants with advanced malignancies. |
| Dose Escalation Q4W Cohorts | Experimental | Drug: AB308, Drug: ZimberelimabEscalating doses of AB308 in combination with zimberelimab (480 mg) will be given every 4 weeks in participants with advanced malignancies. |
| Dose Escalation Q6W Cohort | Experimental | Drug: AB308, Drug: ZimberelimabSelected dose of AB308 in combination with zimberelimab will be given every 6 weeks in participants with advanced malignancies. |
| Dose Expansion Cohort 1 | Experimental | Drug: AB308, Drug: ZimberelimabAB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with in participants with locally advanced or metastatic NSCLC. |
| Dose Expansion Cohort 2 | Experimental | Drug: AB308, Drug: ZimberelimabAB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with melanoma. |
| Dose Expansion Cohort 3 | Experimental | Drug: AB308, Drug: ZimberelimabAB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with metastatic gastric, or gastroesophageal junction, or esophageal cancer. |
| Dose Expansion Cohort 4 | Experimental | Drug: AB308, Drug: ZimberelimabAB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with cervical cancer. |
| Dose Expansion Cohort 5 | Experimental | Drug: AB308, Drug: ZimberelimabAB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with hematological malignancies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Male or female participants ≥ 18 years of age (or age ≥ regionally approved age of consent for participation in investigational clinical studies) at the time of signing the informed consent.
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Adequate organ and marrow function
Key exclusion criteria (6 listed)
- History of trauma or major surgery within 28 days prior to the first dose of study treatment.
- Prior treatment with an anti-TIGIT antibody.
- Any active or prior autoimmune disease that required treatment within 3 years of the first dose of study treatment.
- Prior chemotherapy, targeted small-molecule therapy, immunotherapy, or biologic agents, or use of other investigational drugs within 28 days before first dose of study treatment.
- Discontinued prior immunotherapy for immune related adverse events with a high severity.
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 |
|---|---|---|
| AB308Administered intravenously (IV) as specified in the treatment arm | Drug | Dose Escalation Q3W Cohorts, Dose Escalation Q4W Cohorts, Dose Escalation Q6W Cohort, Dose Expansion Cohort 1, Dose Expansion Cohort 2, Dose Expansion Cohort 3, Dose Expansion Cohort 4, Dose Expansion Cohort 5 |
| ZimberelimabAlso: AB122Administered IV as specified in the treatment arm | Drug | Dose Escalation Q3W Cohorts, Dose Escalation Q4W Cohorts, Dose Escalation Q6W Cohort, Dose Expansion Cohort 1, Dose Expansion Cohort 2, Dose Expansion Cohort 3, Dose Expansion Cohort 4, Dose Expansion Cohort 5 |
Primary outcome
Percentage of participants with Adverse Events
Time frame: From first study treatment administration until up to 90 days after the last dose (Approximately 1 year)
Percentage of participants who experience a Dose Limiting Toxicity
Time frame: From first study treatment administration through Day 21 (Q3W arm) or Day 28 (Q4W arm) or Day 42 (Q6W arm)
7 secondary outcomes
Serum concentration of AB308
Time frame: Recorded at baseline (day 1 of cycle 1), during each of the first 5 cycles (each cycle is 21 days or 28 days or 42 days) and up to the first 16 cycles of treatment (up to 22 months), and 30 and 90 days post last dose (up to approximately 25 months)
Serum concentration of zimberelimab
Time frame: Recorded at baseline (day 1 of cycle 1), during each of the first 5 cycles (each cycle is 21 days or 28 days or 42 days) and up to the first 16 cycles of treatment (up to 22 months), and 30 and 90 days post last dose (up to approximately 25 months)
Percentage of participants with anti-drug antibodies to AB308
Time frame: Recorded at baseline (day 1 of cycle 1), during each of the first 5 cycles (each cycle is 21 days or 28 days or 42 days) and up to the first 16 cycles of treatment (up to 22 months), and 30 and 90 days post last dose (up to approximately 25 months)
Percentage of participants with anti-drug antibodies to zimberelimab
Time frame: Recorded at baseline (day 1 of cycle 1), during each of the first 5 cycles (each cycle is 21 days or 28 days or 42 days) and up to the first 16 cycles of treatment (up to 22 months), and 30 and 90 days post last dose (up to approximately 25 months)
Percentage of participants with Objective Response
Time frame: From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (up to approximately 3-5 years)
Duration of Response
Time frame: From the date of first occurrence of a documented objective response to first documentation of disease progression or death from any cause, whichever occurs first (up to approximately 3-5 years)
Percentage of Participants with Disease Control (complete response, partial response, or stable disease) for >6 months
Time frame: From study enrollment until disease progression or loss of clinical benefit (up to approximately 3-5 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- ARC-12 - Public websiteLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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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
Arcus Biosciences
22 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AB308 and Zimberelimab in people with Advanced Solid Tumor and Non Small Cell Lung Cancer (NSCLC), run by Arcus Biosciences, Inc. at 22 sites in 3 countries.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Spain, Poland. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of participants with Adverse Events (time frame: From first study treatment administration until up to 90 days after the last dose (Approximately 1 year)). 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 28 Aug 2025.