A Study to Evaluate Safety/Tolerability of Immunotherapy Combinations in Participants With Triple-Negative Breast Cancer or Gynecologic Malignancies

Completed · Phase 1

Conditions studied: TNBC - Triple-Negative Breast Cancer, Ovarian Cancer

In brief

This is a Phase 1/1b, open-label, dose-escalation, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and clinical activity of etrumadenant (AB928) in combination with pegylated liposomal doxorubicin (PLD) with or without IPI-549 in participants with advanced metastatic triple-negative breast cancer (TNBC) or ovarian cancer, and etrumadenant in combination with nanoparticle albumin-bound-paclitaxel (NP) in participants with advanced metastatic TNBC.

Key facts

Study ID

NCT03719326

Run by

Arcus Biosciences, Inc.

People needed

35

Starts

2018-10-15

Expected to finish

2021-07-02

Last updated by the study team

2024-05-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female participants, 18 years or older
• Measurable disease per radiographic evaluation
• Performance status 0 or 1
• Available archival tissue sample (within 2 years) or a fresh tumor biopsy may be required
• Adequate organ, cardiac, and bone marrow function
• Dose escalation
• Participants with breast cancer:
• Locally advanced or metastatic triple negative breast cancer (ER-negative, PgR-negative, and HER2-negative according to ASCO/CAP guidelines) with disease progression
• No available alternative or curative therapy
• Participants may have received any number of prior therapies for advanced/recurrent and progressive disease
• Participants with ovarian cancer:
• Locally advanced or metastatic ovarian cancer with disease progression
• No available alternative or curative therapy
• Participants may have received any number of prior therapies for advanced/recurrent and progressive disease
• Dose expansion
• Participants with breast cancer:
• Locally advanced or metastatic triple negative breast cancer (ER-negative, PgR-negative, and HER2-negative according to ASCO/CAP guidelines)
• Disease progression after no more than 3 prior lines of therapy
• Participants with ovarian cancer:
• Locally advanced or metastatic ovarian cancer that is platinum-resistant
• Disease progression after no more than 3 prior lines of therapy

You may not qualify if…

• Received a live, attenuated vaccine within 4 weeks prior to first study treatment
• Prior anticancer treatment including approved agents, systemic radiotherapy, or investigational therapy within 4 weeks prior first study treatment
• Cancer other than the disease under study within 2 years prior to study entry, except for some cancers with a low risk of spreading like non-melanoma skin cancers
• Inability to swallow oral medications
• Participant is breastfeeding, pregnant, or expects to become pregnant during the study
• Active autoimmune disease or documented history of autoimmune disease within 2 years prior to first study treatment
• History of peptic ulcer or stomach bleeding within 6 months prior to first study treatment
• Use of drugs contraindicated by the protocol within 4 weeks prior to and during study treatment
• Prior treatment with drugs that suppress the immune system within 2 weeks prior to first study treatment
• Presence of metastases in the brain or cancer spreading into the cerebrospinal fluid - CSF (leptomeningeal disease)
• HIV, Hepatitis B, and C test results negative prior to first study treatment
• Major surgery within 4 weeks prior to first study treatment
• Participants who have previously received maximum cumulative lifetime anthracycline dosage or baseline ejection fraction <50% (on heart echography)

Where it is running

• Scottsdale Healthcare Hospitals dba Honor Health Research Institute — Scottsdale, Arizona, United States
• Arizona Clinical Research Center — Tucson, Arizona, United States
• University of California, Los Angeles — Los Angeles, California, United States
• Rocky Mountain Cancer Centers (Aurora) — Aurora, Colorado, United States
• Miami Cancer Institute at Baptist Health — Miami, Florida, United States
• Maryland Oncology Hematology, PA — Rockville, Maryland, United States
• HealthPartners Institute Cancer Care Center — Saint Paul, Minnesota, United States
• Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
• Carolina BioOncology Institute — Huntersville, North Carolina, United States
• Willamette Valley Cancer Institute and Research Center — Eugene, Oregon, United States
• Texas Oncology, P.A. - Austin (Midtown) — Austin, Texas, United States
• Texas Oncology, P.A. - Baylor Charles A. Sammons Cancer Center — Dallas, Texas, United States
• Texas Oncology, P.A. - Fort Worth Cancer Center — Fort Worth, Texas, United States
• Texas Oncology, P.A. - San Antonio Northeast — San Antonio, Texas, United States
• Texas Oncology, P.A. - San Antonio Medical Center — San Antonio, Texas, United States
• Texas Oncology, P.A. - Tyler — Tyler, Texas, United States
• Virginia Cancer Specialists, PC — Fairfax, Virginia, United States
• Virginia Oncology Associates — Norfolk, Virginia, United States
• Medical Oncology Associates dba Summit Cancer Centers — Spokane, Washington, United States
• MultiCare Regional Cancer Center — Tacoma, Washington, United States
• Chris O'Brien Lifehouse — Camperdown, New South Wales, Australia
• The Kinghorn Cancer Centre — Darlinghurst, New South Wales, Australia
• St. George Private Hospital — Kogarah, New South Wales, Australia
• Macquarie University — Macquarie, New South Wales, Australia
• Pindara Private Hospital — Benowa, Queensland, Australia

Full record on ClinicalTrials.gov

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