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AB308

Phase 1

Advanced Solid Tumor | Small molecule | Oncology |Arcus Biosciences, Inc.|Trials Updated: Aug 28, 2025

AB308 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Feb 2021

AB308 target and mechanism

Molecular targetTIGIT
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment94

FDA Designations

No designations recorded

AB308 clinical trials

AB308 · 1 trial · 10 indications

Phase 1 1
NCT04772989A Study to Evaluate AB308 in Combination With AB122 in Participants With Advanced MalignanciesAdvanced Solid Tumor
COMPLETED94 Analytics
PHASE1COMPLETED
A Study to Evaluate AB308 in Combination With AB122 in Participants With Advanced Malignancies
Advanced Solid TumorUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of participants with Adverse Events
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
From first study treatment administration through Day 21 (Q3W arm) or Day 28 (Q4W arm) or Day 42 (Q6W arm)

Secondary Endpoints

Serum concentration of AB308
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
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
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)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose Escalation Q3W CohortsEXPERIMENTALEscalating doses of AB308 in combination with zimberelimab (360 mg) will be given every 3 weeks in participants with advanced malignancies.
Dose Escalation Q4W CohortsEXPERIMENTALEscalating doses of AB308 in combination with zimberelimab (480 mg) will be given every 4 weeks in participants with advanced malignancies.
Dose Escalation Q6W CohortEXPERIMENTALSelected dose of AB308 in combination with zimberelimab will be given every 6 weeks in participants with advanced malignancies.
Dose Expansion Cohort 1EXPERIMENTALAB308 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 2EXPERIMENTALAB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with melanoma.
Dose Expansion Cohort 3EXPERIMENTALAB308 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 4EXPERIMENTALAB308 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 5EXPERIMENTALAB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with hematological malignancies.

Interventions

NameTypeDescription
AB308DRUGAdministered intravenously (IV) as specified in the treatment arm
ZimberelimabDRUGAdministered IV as specified in the treatment arm
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites22

Inclusion Criteria: * 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 particip...

Countries:United StatesPolandSpain
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Competitive Landscape -Other Solid Tumors 10 trials (matched to "Advanced Solid Tumor")

Frequently asked questions about AB308

What is AB308?

AB308 is an investigational small molecule being developed by Arcus Biosciences, Inc. for the treatment of advanced solid tumors and other advanced malignancies. It is a Phase 1 oncology candidate and has not been approved by the FDA. It was studied in combination with another agent, AB122, in a completed early-stage clinical trial.

What does AB308 target?

AB308 targets TIGIT, a protein receptor. TIGIT is an immune checkpoint expressed on T cells and natural killer cells, and targeting it is intended to support anti-tumor immune activity. AB308 is a small molecule directed at this protein target, which distinguishes it from antibody-based TIGIT agents.

Who is developing AB308?

AB308 is being developed by Arcus Biosciences, Inc., a biopharmaceutical company that trades under the ticker RCUS. Arcus is the sponsor of the clinical program evaluating AB308 in advanced malignancies, including the completed Phase 1 study conducted in the United States, Poland, and Spain.

What phase is AB308 in?

AB308 is in Phase 1 clinical development. It is an investigational agent and is not FDA approved. The Phase 1 trial evaluating AB308 has been completed, and no active trials of AB308 are currently listed. The program enrolled 94 participants in its completed study.

What clinical trials is AB308 in?

AB308 has been evaluated in the Phase 1 trial NCT04772989, titled A Study to Evaluate AB308 in Combination With AB122 in Participants With Advanced Malignancies. That trial is completed and enrolled 94 participants across the United States, Poland, and Spain. It was a controlled study without randomization or double blinding.

What cancers was AB308 studied in?

AB308 was studied in advanced solid tumors and other advanced malignancies, including non-small cell lung cancer, melanoma, cervical cancer, gastric cancer, gastroesophageal junction adenocarcinoma, esophageal cancer, diffuse large B cell lymphoma, non-Hodgkin lymphoma, and multiple myeloma. The Phase 1 trial NCT04772989 enrolled adults 18 years and older.