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AB308

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment94
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04772989A Study to Evaluate AB308 in Combination With AB122 in Participants With Advanced MalignanciesPHASE1 COMPLETED 94 — — Mar 19, 2021Aug 25, 2025Aug 28, 202522 United States, Poland +1
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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 — 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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