Principal Investigator: Arkadiusz Dudek, MD, PhD
Study sponsor: Arcus Biosciences, Inc.
Locations: Regions Cancer Care Center
Phase of Study: Phase 1
Purpose of study: This study will help us understand whether a potential new treatment, AB928, can be safely given in combination with chemotherapy to subjects with cancer. AB928 will be evaluated in combination with a chemotherapy treatment Pegylated liposomal doxorubicin (PLD) or nanoparticle albumin-bound (nab)- paclitaxel (NP) with or without another experimental drug called IPI-549. AB928 and IPI-549 are considered investigational and are not approved by the U.S Food and Drug Administration (FDA).
– Female participants ≥ 18 years of age at the time of screening.
– Women with no childbearing potential because of surgery or at least 1 year post-menopause, or menopause confirmed by follicle-stimulating hormone testing.
– Must have at least 1 measurable lesion per RECIST v1.1.
– ECOG performance status score of 0 or 1.
– Must have archival tissue sample available for donation.
– Use of any live vaccines against infectious diseases within 4 weeks (28 days) of initiation of investigational product.
– Underlying medical conditions that, in the Investigator’s or Sponsor’s opinion, will make the administration of investigational product hazardous (eg, interstitial lung disease, active infections requiring antibiotics, recent hospitalization with unresolved symptoms) or obscure the interpretation of toxicity determination or AEs, or concurrent medical condition requiring the use of immunosuppressive medications or immunosuppressive doses of systemic or absorbable topical corticosteroids.
– Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
– Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the pre-screening or screening visit through 30 days after the last dose of investigational product regimen.
– Baseline QT interval corrected with Fridericia’s method (QTcF) > 480 ms (average of triplicate readings).
Lisa Wahowske, RN BSN, OCN