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.
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.
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)
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There are 27 Locations for this study
Scottsdale Arizona, 85258, United States
Tucson Arizona, 85715, United States
Los Angeles California, 90095, United States
Aurora Colorado, 80012, United States
Miami Florida, 33176, United States
Rockville Maryland, 20850, United States
Saint Paul Minnesota, 55101, United States
Las Vegas Nevada, 89169, United States
Huntersville North Carolina, 28078, United States
Eugene Oregon, 97401, United States
Austin Texas, 78705, United States
Dallas Texas, 75246, United States
Fort Worth Texas, 76104, United States
San Antonio Texas, 78217, United States
San Antonio Texas, 78240, United States
Tyler Texas, 75702, United States
Fairfax Virginia, 22031, United States
Norfolk Virginia, 23502, United States
Spokane Washington, 99216, United States
Tacoma Washington, 98405, United States
Camperdown New South Wales, 2050, Australia
Darlinghurst New South Wales, 2010, Australia
Kogarah New South Wales, 2217, Australia
Macquarie New South Wales, 2109, Australia
Benowa Queensland, 4217, Australia
Frankston Victoria, 3199, Australia
Malvern Victoria, 3144, Australia
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