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AB801

Phase 1

Advanced Cancer | Small molecule | Oncology |Arcus Biosciences, Inc.|Trials Updated: Oct 9, 2026

AB801 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Aug 2023

AB801 target and mechanism

Molecular targetAXL
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials2
Total Enrollment61

FDA Designations

No designations recorded

AB801 clinical trials

AB801 · 2 trials · 2 indications

Phase 1 2
NCT06120075A Study of AB801 Monotherapy and Combination Therapy in Participants With Advanced MalignanciesAdvanced Cancer
COMPLETED29 Analytics
NCT06004921A Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of AB801 in Healthy VolunteersCancer
COMPLETED32 Analytics
PHASE1COMPLETED
A Study of AB801 Monotherapy and Combination Therapy in Participants With Advanced Malignancies
Advanced CancerUnlock trial analytics
PHASE1COMPLETED
A Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of AB801 in Healthy Volunteers
CancerUnlock trial analytics

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
Number of Participants with Adverse Events (AEs)
Up to 30 days
Area Under the Plasma Drug Concentration-Time Curve (AUC)
Predose, Up to 120 hours postdose
Maximum Concentration (Cmax) in Plasma
Predose, Up to 120 hours postdose
Time to Maximum Concentration (Tmax) in Plasma
Predose, Up to 120 hours postdose
Half-Life Time (t1/2)
Predose, Up to 120 hours postdose

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
Cohort 1 - AB801 Dose AEXPERIMENTALParticipants will receive a single dose of AB801 or placebo
Cohort 2 - AB801 Dose BEXPERIMENTALParticipants will receive a single dose of AB801 or placebo
Cohort 3 - AB801 Dose CEXPERIMENTALParticipants will receive a single dose of AB801 or placebo
Cohort 4 - AB801 Dose DEXPERIMENTALParticipants will receive a single dose of AB801 or placebo

Interventions

NameTypeDescription
AB801DRUGAdministered as specified in the treatment arm
DocetaxelDRUGAdministered as specified in the treatment arm
PlaceboDRUGAdministered as specified in the treatment arm
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Eligibility Criteria

Age Range18 Years to 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 StatesUnited Kingdom
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Competitive Landscape -Cancer 7 trials (matched to "Advanced Cancer")

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Recent Changes (Last 90 Days)

HIGHOct 9, 2026NCT06120075Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHOct 9, 2026NCT06120075Status: ACTIVE_NOT_RECRUITING → COMPLETED
LOWAug 14, 2026NCT06120075lastUpdatePostDate: changed
LOWAug 14, 2026NCT06120075lastUpdatePostDate: changed
LOWAug 14, 2026NCT06120075lastUpdatePostDate: changed

Frequently asked questions about AB801

What is AB801?

AB801 is an investigational small molecule being developed by Arcus Biosciences, Inc. for advanced cancer. It is designed to target the AXL protein and is currently in Phase 1 clinical development. It has been studied as both a monotherapy and in combination with other therapies in participants with advanced malignancies.

What is AB801 used for in advanced cancer?

AB801 is being evaluated for the treatment of advanced cancer. It is an investigational therapy in Phase 1 development and has been studied in participants with advanced malignancies. It is not yet approved for any indication.

What does AB801 target?

AB801 targets the AXL protein, a receptor tyrosine kinase. By inhibiting AXL, AB801 may interfere with signaling pathways that promote tumor growth and survival. This mechanism is being explored in advanced cancer.

Who is developing AB801?

AB801 is being developed by Arcus Biosciences, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol RCUS. The company is focused on developing therapies for cancer.

What phase is AB801 in?

AB801 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any regulatory agency. The Phase 1 program includes studies in both healthy volunteers and participants with advanced cancer.

What clinical trials is AB801 in?

AB801 has been studied in two completed Phase 1 trials: NCT06120075, which evaluated AB801 monotherapy and combination therapy in participants with advanced malignancies, and NCT06004921, which assessed safety, pharmacokinetics, and pharmacodynamics in healthy volunteers. Both trials are listed as completed.