TNBC - Triple-Negative Breast CancerPhase 1NCT03719326
A Study to Evaluate Safety/Tolerability of Immunotherapy Combinations in Participants With Triple-Negative Breast Cancer or Gynecologic Malignancies
A Phase 1 study testing Etrumadenant, IPI-549 and Pegylated liposomal doxorubicin (PLD) in people with TNBC - Triple-Negative Breast Cancer and Ovarian Cancer, run by Arcus Biosciences, Inc. at 27 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- TNBC - Triple-Negative Breast Cancer, Ovarian Cancer
- What is being tested?
- Etrumadenant, IPI-549 and Pegylated liposomal doxorubicin (PLD)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 27 sitesin 2 countries
- Study dates
- 15 Oct 2018to 2 Jul 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 21Show fewer
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
27 sites in 2 countries.
27 sites in 2 countries
United States20 sites
Rocky Mountain Cancer Centers (Aurora)
Aurora, Colorado, 80012
Texas Oncology, P.A. - Austin (Midtown)
Austin, Texas, 78705
Texas Oncology, P.A. - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, 97401
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
Texas Oncology, P.A. - Fort Worth Cancer Center
Fort Worth, Texas, 76104
Carolina BioOncology Institute
Huntersville, North Carolina, 28078
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
University of California, Los Angeles
Los Angeles, California, 90095
Miami Cancer Institute at Baptist Health
Miami, Florida, 33176
Virginia Oncology Associates
Norfolk, Virginia, 23502
Maryland Oncology Hematology, PA
Rockville, Maryland, 20850
HealthPartners Institute Cancer Care Center
Saint Paul, Minnesota, 55101
Texas Oncology, P.A. - San Antonio Northeast
San Antonio, Texas, 78217
Texas Oncology, P.A. - San Antonio Medical Center
San Antonio, Texas, 78240
Scottsdale Healthcare Hospitals dba Honor Health Research Institute
Scottsdale, Arizona, 85258
Medical Oncology Associates dba Summit Cancer Centers
Spokane, Washington, 99216
MultiCare Regional Cancer Center
Tacoma, Washington, 98405
Arizona Clinical Research Center
Tucson, Arizona, 85715
Texas Oncology, P.A. - Tyler
Tyler, Texas, 75702
Australia7 sites
Pindara Private Hospital
Benowa, Queensland, 4217
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050
The Kinghorn Cancer Centre
Darlinghurst, New South Wales, 2010
Peninsula & South Eastern Haematology and Oncology Group
Frankston, Victoria, 3199
St. George Private Hospital
Kogarah, New South Wales, 2217
Macquarie University
Macquarie, New South Wales, 2109
Cabrini Hospital
Malvern, Victoria, 3144
About this study
Official title: A Phase 1/1b Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants With Breast or Gynecologic Malignancies
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.
Read the detailed 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.
- Being tested
- Etrumadenant, IPI-549, Pegylated liposomal doxorubicin (PLD), nanoparticle albumin-bound paclitaxel (NP)
- Keywords
- Triple Negative Breast Cancer, TNBC, Ovarian Cancer
- Medical subject headings
- Triple Negative Breast Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtrumadenantDrug
Also called AB928
Etrumadenant is an A2aR and A2bR antagonist for oral use
IPI-549Drug
IPI-549 is a phosphoinositide-3-kinase-gamma inhibitor for oral use
Pegylated liposomal doxorubicin (PLD)Drug
Doxil is an anthracycline topoisomerase II inhibitor that is encapsulated in liposomes for intravenous (IV) use
nanoparticle albumin-bound paclitaxel (NP)Drug
NP is a microtubule inhibitor for intravenous (IV) use
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation-Arm A | Experimental | Dose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period. Receives: Drug: Etrumadenant; Drug: Pegylated liposomal doxorubicin (PLD) |
| Dose Escalation-Arm B | Experimental | Dose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period. Receives: Drug: Etrumadenant; Drug: nanoparticle albumin-bound paclitaxel (NP) |
| Dose Escalation-Arm C | Experimental | Dose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period. Receives: Drug: Etrumadenant; Drug: IPI-549; Drug: Pegylated liposomal doxorubicin (PLD) |
| Dose Expansion-TNBC-Arm 1 | Experimental | The dose given will be determined from the dose escalation part (Arm A). Receives: Drug: Etrumadenant; Drug: Pegylated liposomal doxorubicin (PLD) |
| Dose Expansion-Ovarian Cancer-Arm 2 | Experimental | The dose given will be determined from the dose escalation part (Arm A). Receives: Drug: Etrumadenant; Drug: Pegylated liposomal doxorubicin (PLD) |
| Dose Expansion-TNBC-Arm 3 | Experimental | The dose given will be determined from the dose escalation part (Arm B). . Receives: Drug: Etrumadenant; Drug: nanoparticle albumin-bound paclitaxel (NP) |
| Dose Expansion-TNBC-Arm 4 | Experimental | The dose expansion will be determined from the dose escalation part (Arm C). Receives: Drug: Etrumadenant; Drug: IPI-549; Drug: Pegylated liposomal doxorubicin (PLD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs)
Measured: 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
Measured: From first dose date to 28 days after the first dose
Secondary outcomes (9)
Plasma concentration of etrumadenant
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Progression Free Survival (PFS) as determined by the Investigator according to RECIST v1.1
Measured: 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)
Overall Survival (OS) as determined by the Investigator according to RECIST v1.1
Measured: From start of treatment up to death from any cause (up to approximately 3-5 years)
Percentage of etrumadenant target inhibition in peripheral blood
Measured: Cycle 1 Day 1 through Cycle 4 Day 1 (4 months) and at the end of treatment (in total approximately 5 months)
Immunophenotyping activity in select immune subsets for etrumadenant and IPI-549 in peripheral blood
Measured: Cycle 1 Day 1 through Cycle 4 Day 1 (4 months) and at the end of treatment (in total approximately 5 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start15 Oct 2018
- Primary completion1 Jul 2021
- Study completion2 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TNBC - Triple-Negative Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 3+3 dose escalation
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arcus Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Infinity Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Arcus Biosciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03719326
- Sponsor's protocol ID
- ARC-2 (AB928CSP0002)
- Status last verified
- May 2024
- First submitted
- 15 Oct 2018
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/1b Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants With Breast or Gynecologic Malignancies
- ClinicalTrials.gov ID
- NCT03719326
- Acronym / sponsor ID
- ARC-2 (AB928CSP0002)
- Keywords
- Triple Negative Breast Cancer, TNBC, Ovarian Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Arcus Biosciences, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Infinity Pharmaceuticals, Inc.
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 2 Jul 2021 (actual)
- First posted
- 25 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
- Model description
- 3+3 dose escalation
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation-Arm A | Experimental | Drug: Etrumadenant, Drug: Pegylated liposomal doxorubicin (PLD)Dose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period. |
| Dose Escalation-Arm B | Experimental | Drug: Etrumadenant, Drug: nanoparticle albumin-bound paclitaxel (NP)Dose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period. |
| Dose Escalation-Arm C | Experimental | Drug: Etrumadenant, Drug: IPI-549, Drug: Pegylated liposomal doxorubicin (PLD)Dose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period. |
| Dose Expansion-TNBC-Arm 1 | Experimental | Drug: Etrumadenant, Drug: Pegylated liposomal doxorubicin (PLD)The dose given will be determined from the dose escalation part (Arm A). |
| Dose Expansion-Ovarian Cancer-Arm 2 | Experimental | Drug: Etrumadenant, Drug: Pegylated liposomal doxorubicin (PLD)The dose given will be determined from the dose escalation part (Arm A). |
| Dose Expansion-TNBC-Arm 3 | Experimental | Drug: Etrumadenant, Drug: nanoparticle albumin-bound paclitaxel (NP)The dose given will be determined from the dose escalation part (Arm B). . |
| Dose Expansion-TNBC-Arm 4 | Experimental | Drug: Etrumadenant, Drug: IPI-549, Drug: Pegylated liposomal doxorubicin (PLD)The dose expansion will be determined from the dose escalation part (Arm C). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EtrumadenantAlso: AB928Etrumadenant is an A2aR and A2bR antagonist for oral use | Drug | Dose Escalation-Arm A, Dose Escalation-Arm B, Dose Escalation-Arm C, Dose Expansion-Ovarian Cancer-Arm 2, Dose Expansion-TNBC-Arm 1, Dose Expansion-TNBC-Arm 3, Dose Expansion-TNBC-Arm 4 |
| IPI-549IPI-549 is a phosphoinositide-3-kinase-gamma inhibitor for oral use | Drug | Dose Escalation-Arm C, Dose Expansion-TNBC-Arm 4 |
| Pegylated liposomal doxorubicin (PLD)Doxil is an anthracycline topoisomerase II inhibitor that is encapsulated in liposomes for intravenous (IV) use | Drug | Dose Escalation-Arm A, Dose Escalation-Arm C, Dose Expansion-Ovarian Cancer-Arm 2, Dose Expansion-TNBC-Arm 1, Dose Expansion-TNBC-Arm 4 |
| nanoparticle albumin-bound paclitaxel (NP)NP is a microtubule inhibitor for intravenous (IV) use | Drug | Dose Escalation-Arm B, Dose Expansion-TNBC-Arm 3 |
Primary outcome
Incidence of Adverse Events (AEs)
Time frame: 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
Time frame: From first dose date to 28 days after the first dose
9 secondary outcomes
Plasma concentration of etrumadenant
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Progression Free Survival (PFS) as determined by the Investigator according to RECIST v1.1
Time frame: 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)
Overall Survival (OS) as determined by the Investigator according to RECIST v1.1
Time frame: From start of treatment up to death from any cause (up to approximately 3-5 years)
Percentage of etrumadenant target inhibition in peripheral blood
Time frame: Cycle 1 Day 1 through Cycle 4 Day 1 (4 months) and at the end of treatment (in total approximately 5 months)
Immunophenotyping activity in select immune subsets for etrumadenant and IPI-549 in peripheral blood
Time frame: Cycle 1 Day 1 through Cycle 4 Day 1 (4 months) and at the end of treatment (in total approximately 5 months).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- ARC-2 - Lay Summary (English Version)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Arcus Biosciences, Inc.
27 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Etrumadenant, IPI-549 and Pegylated liposomal doxorubicin (PLD) in people with TNBC - Triple-Negative Breast Cancer and Ovarian Cancer, run by Arcus Biosciences, Inc. at 27 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AEs) (time frame: From first dose date to 30 days after the last dose (Approximately 1 year)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024; AzTrials last refreshed its copy on 26 Oct 2026.