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A Study of AB801 Monotherapy and Combination Therapy in Participants With Advanced Malignancies

Status
Active
Cancer Type
Bladder Cancer
Breast Cancer
Colon/Rectal Cancer
Head and Neck Cancer
Kidney Cancer
Lung Cancer
Ovarian Cancer
Unknown Primary
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT06120075
Protocol IDs
ARC-27 (primary)
NCI-2024-03901
Study Sponsor
Arcus Biosciences, Inc.

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.

Eligibility

  1. Monotherapy-specific criteria for dose escalation cohorts:
  2. 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 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.
  3. Disease-specific criteria for dose-expansion Cohort 1 (STK11m [mutated or deleted] NSCLC):
  4. Cytologically or pathologically confirmed locally advanced unresectable or metastatic (Stage IIIB-IV per American Joint Committee on Cancer [AJCC] version 8) non-squamous NSCLC with documented mutation or deletion in the STK11 gene.
  5. 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.
  6. Previously treated in the unresectable locally advanced or metastatic setting with a platinum-containing chemotherapy and programmed cell death ligand-1 (PD-L1) inhibitor.
  7. Disease-specific criteria for dose-expansion Cohort 2 (NSCLC):
  8. 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.
  9. Previously treated in the unresectable locally advanced or metastatic setting with a platinum-containing chemotherapy and PD-(L)-1inhibitor.
  10. 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.
  11. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. Key

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.