An Open-label Phase 1b Study of ORIC-101 in Combination With Anticancer Therapy in Patients With Advanced or Metastatic Solid Tumors
The purpose of this study is to establish the recommended Phase 2 dose (RP2D), safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of ORIC-101 in combination with nab-paclitaxel or other anticancer therapies when administered to patients with advanced or metastatic solid tumors.
• Advanced or metastatic solid tumor, with the exception of neuroendocrine tumors that secrete adrenocorticotropic hormone (ACTH) or corticotropin-releasing hormone (CRH), for which no alternative effective standard therapy is available or for which standard therapy is considered unsuitable or intolerable
• Measurable disease (ie, presenting with at least one measurable lesion per RECIST 1.1)
• Radiographic evidence of a lesion that may be safely biopsied by core needle biopsy
• For patients with treated, stable CNS metastases that are asymptomatic: no evidence of progression for at least 4 weeks after CNS-directed treatment as determined by clinical examination and brain imaging. Patients must not require steroids
• ECOG performance status 0 or 1
• Life expectancy of at least 3 months
• Available archival FFPE tissue for submission to central laboratory
• Male: must agree to birth control requirements and Female: not pregnant, breastfeeding, and meets requirements regarding women of child-bearing potential
• Capable of giving signed informed consent
• Agreement and ability to undergo two on-study biopsies, as follows, through a procedure that is deemed to be clinically feasible and not carry significant risk:
‣ one pre-treatment tumor biopsy obtained prior to dosing; and
⁃ one post-treatment tumor biopsy during Cycle 2