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AB801

Phase 1

Advanced Cancer | Small molecule | Oncology |Arcus Biosciences, Inc.|Last Updated: Jun 2, 2026

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 Enrollment91
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06120075A Study of AB801 Monotherapy and Combination Therapy in Participants With Advanced MalignanciesPHASE1 ACTIVE NOT_RECRUITING 91 — — Jan 19, 2024Nov 1, 2026Jun 2, 202610 United States
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Study Endpoints
Primary Endpoints
Number of Participants With Adverse Events
Up to 2 years
Dose Escalation Cohorts: Number of Participants With Dose-Limiting Toxicities (DLTs)
Up to 2 years
Secondary Endpoints
Area Under the Plasma Drug Concentration-Time Curve (AUC)
Predose, Up to 8 hours postdose
Maximum Concentration (Cmax) in Plasma
Predose, Up to 8 hours postdose
Time to Maximum Concentration (Tmax) in Plasma
Predose, Up to 8 hours postdose
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose Escalation Cohort 1 - AB801 capsule Dose Level 1EXPERIMENTALParticipants will receive AB801 orally daily
Dose Escalation Cohort 2 - AB801 capsule Dose Level 2EXPERIMENTALParticipants will receive AB801 orally daily
Dose Escalation Cohort 3 - AB801 capsule Dose Level 3EXPERIMENTALParticipants will receive AB801 orally daily
Dose Escalation Cohort 4 - AB801 capsule Dose Level 4EXPERIMENTALParticipants will receive AB801 orally daily
Dose Escalation Cohort 5 - AB801 tablets Dose Level 5EXPERIMENTALParticipants will receive AB801 orally daily
Dose Escalation Cohort 6 - AB801 tablets Dose Level 6EXPERIMENTALParticipants will receive AB801 orally daily
Dose Escalation Cohort 7 - AB801 tablets Dose Level 7EXPERIMENTALParticipants will receive AB801 orally daily
Dose Expansion Cohort - AB801 + DocetaxelEXPERIMENTALParticipants with NSCLC will receive AB801 orally in combination with docetaxel IV infusion
Interventions
NameTypeDescription
AB801DRUGAdministered as specified in the treatment arm
DocetaxelDRUGAdministered as specified in the treatment arm
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites10

Key Inclusion Criteria: * Monotherapy-specific criteria for dose escalation cohorts: * Participants may have cytologically or pathologically confirmed non-small cell lung carcinoma (NSCLC), colorectal carcinoma (CRC), breast, ovarian, renal cell carcinoma (RCC), head and neck squamous cell carci...

Countries:United States
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Competitive Landscape -Cancer 5 trials
CompanyTickerTrialsLead PhaseDrugs
GE Healthcare Technologies Inc.GEHC1PHASE1GEH200520 / GEH200521 - Part A
Zimmer Biomet Holdings, Inc.ZBH1 — Undisclosed
Ascentage Pharma Group International Unsponsored ADRAAPG1PHASE1Olverembatinib
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Recent Changes (Last 90 Days)
LOWJun 2, 2026NCT06120075lastUpdatePostDate: changed
LOWJun 2, 2026NCT06120075lastUpdatePostDate: changed
LOWJun 2, 2026NCT06120075lastUpdatePostDate: changed
LOWMay 26, 2026NCT06120075primaryCompletionDate: changed
LOWMay 24, 2026NCT06120075studyFirstPostDate: changed