Advanced CancerPhase 1ARC-27NCT06120075
A Study of AB801 Monotherapy and Combination Therapy in Participants With Advanced Malignancies
A Phase 1 study testing AB801 and Docetaxel in people with Advanced Cancer, run by Arcus Biosciences, Inc. at 10 sites in United States.
Trial summary
The primary purpose of this study is to assess the safety and tolerability of AB801 in participants with advanced malignancies, and to determine a recommended AB801 dose for expansion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- AB801 and Docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 10 sitesUnited States
- Study dates
- 19 Jan 2024to 29 Apr 2026
- 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
- 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 carcinoma (HNSCC), or bladder (including urothelial malignancies of the renal pelvis and ureter) carcinoma that has progressed or was non-responsive to available therapies with no standard of care (SOC) options, or for whom standard therapy has proven ineffective, intolerable, or considered inappropriate; or for whom a clinical study of an investigational agent is a recognized SOC.
- Disease-specific criteria for dose-expansion (NSCLC):
- Cytologically or pathologically confirmed locally advanced unresectable or metastatic (Stage IIIB-IV per American Joint Committee on Cancer version 8) non-squamous NSCLC negative for actionable mutations in EGFR, ALK, ROS1, NTRK, C-MET, or RET. Mixed SCLC and squamous NSCLC histology is not permitted.
- Previously treated in the unresectable locally advanced or metastatic setting with a platinum-containing chemotherapy and PD-(L)-1inhibitor.
- Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) guidance (Version 1.1) (Section 1.1). The measurable lesion must be outside of a radiation field if the participant received prior radiation unless discussed and approved by the study physician.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Who cannot join
- Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of investigational product.
- Underlying medical conditions or adverse events that, in the physician or sponsor's opinion, will make the administration of investigational products hazardous.
- Prolonged QT interval defined as mean corrected QT interval (QTc) ≥ 450 milliseconds (ms).
- Any active or documented history of autoimmune disease, including but not limited to inflammatory bowel disease, celiac disease, Wegner syndrome, Hashimoto syndrome, systemic lupus erythematosus, scleroderma, sarcoidosis, or autoimmune hepatitis, within 3 years of the first dose of study treatment.
- Treatment with systemic immunosuppressive medication (including but not limited to corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and antitumor necrosis factor-α agents) administered within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressant medication during study treatment.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Research Site
Atlanta, Georgia, 30322
Research Site
Dallas, Texas, 75230
Research Site
Denver, Colorado, 80218
Research Site
Fairfax, Virginia, 22031
Research Site
Grand Rapids, Michigan, 49546
Research Site
New York, New York, 10128
Research Site
Philadelphia, Pennsylvania, 19104
Research Site
San Antonio, Texas, 78229
Research Site
Washington D.C., District of Columbia, 20007
Research Site
West Valley City, Utah, 84119
About this study
Official title: A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB801 Monotherapy and Combination Therapy in Participants With Advanced Malignancies
The primary purpose of this study is to assess the safety and tolerability of AB801 in participants with advanced malignancies, and to determine a recommended AB801 dose for expansion.
- Conditions
- Advanced Cancer
- Being tested
- AB801, Docetaxel
- Keywords
- AB801, Non-small cell lung cancer (NSCLC)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AB801Drug
Administered as specified in the treatment arm
DocetaxelDrug
Administered as specified in the treatment arm
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Cohort 1 - AB801 capsule Dose Level 1 | Experimental | Participants will receive AB801 orally daily Receives: Drug: AB801 |
| Dose Escalation Cohort 2 - AB801 capsule Dose Level 2 | Experimental | Participants will receive AB801 orally daily Receives: Drug: AB801 |
| Dose Escalation Cohort 3 - AB801 capsule Dose Level 3 | Experimental | Participants will receive AB801 orally daily Receives: Drug: AB801 |
| Dose Escalation Cohort 4 - AB801 capsule Dose Level 4 | Experimental | Participants will receive AB801 orally daily Receives: Drug: AB801 |
| Dose Escalation Cohort 5 - AB801 tablets Dose Level 5 | Experimental | Participants will receive AB801 orally daily Receives: Drug: AB801 |
| Dose Escalation Cohort 6 - AB801 tablets Dose Level 6 | Experimental | Participants will receive AB801 orally daily Receives: Drug: AB801 |
| Dose Escalation Cohort 7 - AB801 tablets Dose Level 7 | Experimental | Participants will receive AB801 orally daily Receives: Drug: AB801 |
| Dose Expansion Cohort - AB801 + Docetaxel | Experimental | Participants with NSCLC will receive AB801 orally in combination with docetaxel IV infusion Receives: Drug: AB801; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Measured: Up to 2 years
Dose Escalation Cohorts: Number of Participants With Dose-Limiting Toxicities (DLTs)
Measured: Up to 2 years
Secondary outcomes (5)
Area Under the Plasma Drug Concentration-Time Curve (AUC)
Measured: Predose, Up to 8 hours postdose
Maximum Concentration (Cmax) in Plasma
Measured: Predose, Up to 8 hours postdose
Time to Maximum Concentration (Tmax) in Plasma
Measured: Predose, Up to 8 hours postdose
Objective response rate (ORR) as Assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured: Up to 2 years
Dose Expansion Cohorts: Duration of Response (DOR) as Assessed per RECIST v1.1
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start19 Jan 2024
- Primary completion29 Apr 2026
- Study completion29 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arcus Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Arcus Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06120075
- Sponsor's protocol ID
- ARC-27
- Acronym
- ARC-27
- Status last verified
- Apr 2026
- First submitted
- 1 Nov 2023
- Last updated
- 9 Oct 2026
- 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 9 Oct 2026. 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 AB801 Monotherapy and Combination Therapy in Participants With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT06120075
- Acronym / sponsor ID
- ARC-27 / ARC-27
- Conditions
- Advanced Cancer
- Keywords
- AB801, Non-small cell lung cancer (NSCLC)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Arcus Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Jan 2024 (actual)
- Primary completion
- 29 Apr 2026 (actual)
- Study completion
- 29 Apr 2026 (actual)
- First posted
- 7 Nov 2023 (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.
The primary purpose of this study is to assess the safety and tolerability of AB801 in participants with advanced malignancies, and to determine a recommended AB801 dose for expansion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Cohort 1 - AB801 capsule Dose Level 1 | Experimental | Drug: AB801Participants will receive AB801 orally daily |
| Dose Escalation Cohort 2 - AB801 capsule Dose Level 2 | Experimental | Drug: AB801Participants will receive AB801 orally daily |
| Dose Escalation Cohort 3 - AB801 capsule Dose Level 3 | Experimental | Drug: AB801Participants will receive AB801 orally daily |
| Dose Escalation Cohort 4 - AB801 capsule Dose Level 4 | Experimental | Drug: AB801Participants will receive AB801 orally daily |
| Dose Escalation Cohort 5 - AB801 tablets Dose Level 5 | Experimental | Drug: AB801Participants will receive AB801 orally daily |
| Dose Escalation Cohort 6 - AB801 tablets Dose Level 6 | Experimental | Drug: AB801Participants will receive AB801 orally daily |
| Dose Escalation Cohort 7 - AB801 tablets Dose Level 7 | Experimental | Drug: AB801Participants will receive AB801 orally daily |
| Dose Expansion Cohort - AB801 + Docetaxel | Experimental | Drug: AB801, Drug: DocetaxelParticipants with NSCLC will receive AB801 orally in combination with docetaxel IV infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Monotherapy-specific criteria for dose escalation cohorts:
- Disease-specific criteria for dose-expansion (NSCLC):
- Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) guidance (Version 1.1) (Section 1.1). The measurable lesion must be outside of a radiation field if the participant received prior radiation unless discussed and approved by the study physician.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Key exclusion criteria (6 listed)
- Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of investigational product.
- Underlying medical conditions or adverse events that, in the physician or sponsor's opinion, will make the administration of investigational products hazardous.
- Prolonged QT interval defined as mean corrected QT interval (QTc) ≥ 450 milliseconds (ms).
- Any active or documented history of autoimmune disease, including but not limited to inflammatory bowel disease, celiac disease, Wegner syndrome, Hashimoto syndrome, systemic lupus erythematosus, scleroderma, sarcoidosis, or autoimmune hepatitis, within 3 years of the first dose of study treatment.
- Treatment with systemic immunosuppressive medication (including but not limited to corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and antitumor necrosis factor-α agents) administered within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressant medication during study treatment.
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 |
|---|---|---|
| AB801Administered as specified in the treatment arm | Drug | Dose Escalation Cohort 1 - AB801 capsule Dose Level 1, Dose Escalation Cohort 2 - AB801 capsule Dose Level 2, Dose Escalation Cohort 3 - AB801 capsule Dose Level 3, Dose Escalation Cohort 4 - AB801 capsule Dose Level 4, Dose Escalation Cohort 5 - AB801 tablets Dose Level 5, Dose Escalation Cohort 6 - AB801 tablets Dose Level 6, Dose Escalation Cohort 7 - AB801 tablets Dose Level 7, Dose Expansion Cohort - AB801 + Docetaxel |
| DocetaxelAdministered as specified in the treatment arm | Drug | Dose Expansion Cohort - AB801 + Docetaxel |
Primary outcome
Number of Participants With Adverse Events
Time frame: Up to 2 years
Dose Escalation Cohorts: Number of Participants With Dose-Limiting Toxicities (DLTs)
Time frame: Up to 2 years
5 secondary outcomes
Area Under the Plasma Drug Concentration-Time Curve (AUC)
Time frame: Predose, Up to 8 hours postdose
Maximum Concentration (Cmax) in Plasma
Time frame: Predose, Up to 8 hours postdose
Time to Maximum Concentration (Tmax) in Plasma
Time frame: Predose, Up to 8 hours postdose
Objective response rate (ORR) as Assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Up to 2 years
Dose Expansion Cohorts: Duration of Response (DOR) as Assessed per RECIST v1.1
Time frame: Up to 2 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 9 Oct 2026.
- ARC-27 - 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
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AB801 and Docetaxel in people with Advanced Cancer, run by Arcus Biosciences, Inc. at 10 sites in United States.
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 7 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 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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?
Number of Participants With Adverse Events (time frame: Up to 2 years). 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 9 Oct 2026.