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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03719326
Other study ID # ARC-2 (AB928CSP0002)
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 15, 2018
Est. completion date July 2, 2021

Study information

Verified date May 2024
Source Arcus Biosciences, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date July 2, 2021
Est. primary completion date July 1, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Etrumadenant
Etrumadenant is an A2aR and A2bR antagonist for oral use
IPI-549
IPI-549 is a phosphoinositide-3-kinase-gamma inhibitor for oral use
Pegylated liposomal doxorubicin (PLD)
Doxil is an anthracycline topoisomerase II inhibitor that is encapsulated in liposomes for intravenous (IV) use
nanoparticle albumin-bound paclitaxel (NP)
NP is a microtubule inhibitor for intravenous (IV) use

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Arcus Biosciences, Inc. Infinity Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Adverse Events (AEs) From first dose date to 30 days after the last dose (Approximately 1 year)
Primary Incidence of dose-limiting toxicities (DLTs) during the dose escalation phase From first dose date to 28 days after the first dose
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary Progression Free Survival (PFS) as determined by the Investigator according to RECIST v1.1 From start of the treatment up to first occurrence of progressive disease or death from any cause, whichever occurs first (up to approximately 3-5 years)
Secondary Overall Survival (OS) as determined by the Investigator according to RECIST v1.1 From start of treatment up to death from any cause (up to approximately 3-5 years)
Secondary Percentage of etrumadenant target inhibition in peripheral blood Cycle 1 Day 1 through Cycle 4 Day 1 (4 months) and at the end of treatment (in total approximately 5 months)
Secondary Immunophenotyping activity in select immune subsets for etrumadenant and IPI-549 in peripheral blood Cycle 1 Day 1 through Cycle 4 Day 1 (4 months) and at the end of treatment (in total approximately 5 months).
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