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Monoclonal Antibodies

Dose Escalation Cohort 5 - AB801 Dose Level 5 for Cancer (ARC-27 Trial)

Phase 1

Recruiting

Research Sponsored by Arcus Biosciences, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Negative for actionable mutations including epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), c-ros oncogene 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), mesenchymal-epithelial transition factor (C-MET) or ret proto-oncogene (RET). Mixed small-cell lung carcinoma (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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

ARC-27 Trial Summary

This trial is being conducted to evaluate the safety and tolerability of a drug called AB801 in patients with advanced cancer. The study also aims to identify the appropriate dose of AB801 for further testing.

Who is the study for?

This trial is for adults with certain advanced cancers like lung, colorectal, breast, ovarian, kidney, head and neck, or bladder cancer that's worsened despite treatment. They should have no standard care options left or can't tolerate them. Participants need at least one measurable tumor and must be in good physical condition (ECOG score 0-1).Check my eligibility

What is being tested?

The study tests AB801 alone and combined with other drugs (Zimberelimab and Docetaxel) to find a safe dose for people with advanced malignancies. It aims to see how well participants tolerate AB801 and determine the best dose for further research.See study design

What are the potential side effects?

Possible side effects of AB801 include typical reactions related to immune therapies such as fatigue, skin reactions, digestive issues, liver inflammation, hormonal gland problems which might affect hormone levels.

ARC-27 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer does not have specific genetic changes and is not a mix of small-cell and squamous types.

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I've had treatment with platinum-based chemo and PD-(L)1 inhibitor for advanced cancer.

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I am fully active or can carry out light work.

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My advanced non-squamous NSCLC has a confirmed STK11 gene mutation.

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I've had treatments with platinum-based chemo and PD-L1 inhibitors for advanced cancer.

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My advanced lung cancer is not operable and lacks certain genetic mutations.

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It seems like the criterion is missing. Could you please provide more details or context so that I can assist you accurately?

ARC-27 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose Escalation Cohorts: Number of Participants With Dose-Limiting Toxicities (DLTs)

Number of Participants With Adverse Events

Secondary outcome measures

Area Under the Plasma Drug Concentration-Time Curve (AUC)

Dose Expansion Cohorts: Duration of Response (DOR) as Assessed per RECIST v1.1

Maximum Concentration (Cmax) in Plasma

+2 more

ARC-27 Trial Design

8Treatment groups

Experimental Treatment

Group I: Dose Expansion Cohort 2 - AB801 + DocetaxelExperimental Treatment2 Interventions

Participants with NSCLC will receive AB801 orally in combination with docetaxel IV infusion

Group II: Dose Expansion Cohort 1- AB801 + Zimberelimab + DocetaxelExperimental Treatment3 Interventions

Participants with NSCLC with known mutation or deletion of serine/threonine kinase 11 gene will receive AB801 orally in combination with zimberelimab and docetaxel administered via intravenous (IV) infusion

Group III: Dose Escalation Cohort 6 - AB801 Dose Level 6Experimental Treatment1 Intervention