Breast Cancer Clinical Trial

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

Summary

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.

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Full Description

In the dose escalation phase, the following will be assessed:

Arm A: escalating doses of etrumadenant in combination with PLD at standard doses will be assessed in participants with advanced metastatic triple-negative breast cancer or ovarian cancer. Eligible participants will receive oral administration of etrumadenant as well as intravenous (IV) infusion of PLD. The recommended dose (RDE) for expansion Arms 1 and 2 and escalation Arm C will be determined upon completion of this dose escalation arm.
Arm B: escalating doses of etrumadenant in combination with the NP at standard doses will also be assessed in participants with advanced metastatic TNBC. Eligible participants will receive oral administration of etrumadenant as well as NP infusion. The RDE of etrumadenant will be determined upon completion of this dose escalation arm.
Arm C: escalating doses of IPI-549 in combination with the RDE of etrumadenant (from Arm A) and PLD at standard doses will be assessed in participants with advanced metastatic TNBC or ovarian cancer. Eligible participants will receive oral administration of both etrumadenant and IPI-549 as well as IV infusion of PLD. The RDE of IPI-549 for expansion Arm 4 will be determined upon completion of this dose escalation arm.

In the dose expansion phase, the following will be assessed:

Arms 1 and 2: Etrumadenant at the RDE in combination with PLD at standard doses may be assessed in participants with advanced metastatic TNBC or ovarian cancer.
Arm 3: Etrumadenant at the RDE in combination with NP at standard doses may be assessed in participants with advanced metastatic TNBC.
Arm 4: Etrumadenant and IPI-549 at the RDE in combination with PLD at standard doses may be assessed in participants with advanced metastatic TNBC.

Overall duration of treatment will depend on how well the treatment is tolerated. Treatment may continue until unacceptable toxicity or progressive disease or other reasons specified in the protocol.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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)

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

35

Study ID:

NCT03719326

Recruitment Status:

Completed

Sponsor:

Arcus Biosciences, Inc.

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There are 27 Locations for this study

See Locations Near You

Scottsdale Healthcare Hospitals dba Honor Health Research Institute
Scottsdale Arizona, 85258, United States
Arizona Clinical Research Center
Tucson Arizona, 85715, United States
University of California, Los Angeles
Los Angeles California, 90095, United States
Rocky Mountain Cancer Centers (Aurora)
Aurora Colorado, 80012, United States
Miami Cancer Institute at Baptist Health
Miami Florida, 33176, United States
Maryland Oncology Hematology, PA
Rockville Maryland, 20850, United States
HealthPartners Institute Cancer Care Center
Saint Paul Minnesota, 55101, United States
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89169, United States
Carolina BioOncology Institute
Huntersville North Carolina, 28078, United States
Willamette Valley Cancer Institute and Research Center
Eugene Oregon, 97401, United States
Texas Oncology, P.A. - Austin (Midtown)
Austin Texas, 78705, United States
Texas Oncology, P.A. - Baylor Charles A. Sammons Cancer Center
Dallas Texas, 75246, United States
Texas Oncology, P.A. - Fort Worth Cancer Center
Fort Worth Texas, 76104, United States
Texas Oncology, P.A. - San Antonio Northeast
San Antonio Texas, 78217, United States
Texas Oncology, P.A. - San Antonio Medical Center
San Antonio Texas, 78240, United States
Texas Oncology, P.A. - Tyler
Tyler Texas, 75702, United States
Virginia Cancer Specialists, PC
Fairfax Virginia, 22031, United States
Virginia Oncology Associates
Norfolk Virginia, 23502, United States
Medical Oncology Associates dba Summit Cancer Centers
Spokane Washington, 99216, United States
MultiCare Regional Cancer Center
Tacoma Washington, 98405, United States
Chris O'Brien Lifehouse
Camperdown New South Wales, 2050, Australia
The Kinghorn Cancer Centre
Darlinghurst New South Wales, 2010, Australia
St. George Private Hospital
Kogarah New South Wales, 2217, Australia
Macquarie University
Macquarie New South Wales, 2109, Australia
Pindara Private Hospital
Benowa Queensland, 4217, Australia
Peninsula & South Eastern Haematology and Oncology Group
Frankston Victoria, 3199, Australia
Cabrini Hospital
Malvern Victoria, 3144, Australia

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

35

Study ID:

NCT03719326

Recruitment Status:

Completed

Sponsor:


Arcus Biosciences, Inc.

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