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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03719326.
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.
Lead OrganizationArcus Biosciences