An Open-label Phase 1b Study of ORIC-101 in Combination With Anticancer Therapy in Patients With Advanced or Metastatic Solid Tumors

Status: Terminated
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Stanford Cancer Institute
Palo Alto
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco
Colorado
University of Colorado - PPDS
Aurora
Florida
Florida Cancer Specialists & Research Institute
Lake Mary
Florida Cancer Specialists & Research Institute
Sarasota
Oregon
Oregon Health & Science University
Portland
Tennessee
Tennessee Oncology NASH - SCRI - PPDS
Nashville
Texas
Mary Crowley Cancer Research Centers - Medical City
Dallas
University of Texas MD Anderson Cancer Center
Houston
NEXT Oncology
San Antonio
Utah
University of Utah - Huntsman Cancer Institute - PPDS
Salt Lake City
Virginia
Virginia Cancer Specialists, PC
Fairfax
Time Frame
Start Date: 2019-05-02
Completion Date: 2023-12-04
Participants
Target number of participants: 83
Treatments
Experimental: Dose Escalation (Part I)
ORIC-101 dosed orally, once per day, for 5 or 7 days/week in combination with nab-paclitaxel (75 or 100 mg/m2 on Days 1, 8, and 15) of each 28-day cycle.
Experimental: Dose Expansion (Part II)
RP2D dose
Sponsors
Leads: ORIC Pharmaceuticals

This content was sourced from clinicaltrials.gov