A Study to Evaluate Safety/Tolerability of Immunotherapy Combinations in Participants With Triple-Negative Breast Cancer or Gynecologic Malignancies
A Phase 1/1b Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants With Breast or Gynecologic Malignancies
1 other identifier
interventional
35
2 countries
27
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2018
Typical duration for phase_1
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2018
CompletedStudy Start
First participant enrolled
October 15, 2018
CompletedFirst Posted
Study publicly available on registry
October 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 2, 2021
CompletedMay 24, 2024
May 1, 2024
2.7 years
October 15, 2018
May 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of Adverse Events (AEs)
From first dose date to 30 days after the last dose (Approximately 1 year)
Incidence of dose-limiting toxicities (DLTs) during the dose escalation phase
From first dose date to 28 days after the first dose
Secondary Outcomes (9)
Plasma concentration of etrumadenant
Recorded at baseline (prior to first dose), during the first 4 cycles of treatment (4 months) and at the end of treatment (i.e. in total approximately 5 months)
Plasma concentration of IPI-549
Recorded at baseline (prior to first dose), during the first 4 cycles of treatment (4 months) and at the end of treatment (i.e. in total approximately 5 months)
Percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR), as determined by Investigator according to Response Evaluation in Solid Tumors (RECIST) v 1.1
From study enrollment until participation discontinuation, first occurrence of progressive disease or death from any cause, whichever occurs first (approximately 3-5 years)
Percentage of participants with Disease Control (complete response, partial response, or stable disease) for > 6 months as determined by RECIST v1.1
From study enrollment until disease progression or loss of clinical benefit (up to approximately 3-5 years)
Duration of Response as determined by the Investigator according to RECIST v1.1
From the date of the first occurrence of a documented objective response to first documentation of disease progression or death from any cause, whichever occurs first (up to approximately 3-5 years)
- +4 more secondary outcomes
Study Arms (7)
Dose Escalation-Arm A
EXPERIMENTALDose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period.
Dose Escalation-Arm B
EXPERIMENTALDose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period.
Dose Escalation-Arm C
EXPERIMENTALDose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period.
Dose Expansion-TNBC-Arm 1
EXPERIMENTALThe dose given will be determined from the dose escalation part (Arm A).
Dose Expansion-Ovarian Cancer-Arm 2
EXPERIMENTALThe dose given will be determined from the dose escalation part (Arm A).
Dose Expansion-TNBC-Arm 3
EXPERIMENTALThe dose given will be determined from the dose escalation part (Arm B). .
Dose Expansion-TNBC-Arm 4
EXPERIMENTALThe dose expansion will be determined from the dose escalation part (Arm C).
Interventions
Etrumadenant is an A2aR and A2bR antagonist for oral use
IPI-549 is a phosphoinositide-3-kinase-gamma inhibitor for oral use
Doxil is an anthracycline topoisomerase II inhibitor that is encapsulated in liposomes for intravenous (IV) use
NP is a microtubule inhibitor for intravenous (IV) use
Eligibility Criteria
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
- +6 more criteria
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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Arcus Biosciences, Inc.lead
- Infinity Pharmaceuticals, Inc.collaborator
Study Sites (27)
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Arcus Biosciences, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2018
First Posted
October 25, 2018
Study Start
October 15, 2018
Primary Completion
July 1, 2021
Study Completion
July 2, 2021
Last Updated
May 24, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
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.