NCT03928314

Study of ORIC-101 in Combination With Anticancer Therapy

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: ORIC Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

ORIC-101 is a small molecule GR antagonist being developed for the treatment of patients with solid tumor malignancies. Mechanistically, ORIC-101 inhibits GR transcriptional activity and blocks the pro-survival signals mediated by the activated nuclear receptor. This is an open-label, uncontrolled, multicenter, dose-finding study to assess the safety and preliminary antitumor activity of ORIC-101 in combination with nab-paclitaxel or other anticancer therapy in patients with advanced or metastatic solid tumors. The study will begin with dose finding in combination initially with nab-paclitaxel in patients with various solid tumors (Part I); additional dose expansion cohorts in specific tumor types with nab-paclitaxel (Part II) or with other anticancer therapies may be evaluated through protocol amendment(s). The study will first evaluate intermittent administration (5 days on, 2 days off for 21 days) of ORIC-101 followed by continuous administration (daily for 21 days) in combination with nab-paclitaxel using a standard 3+3 dose escalation design. In Part II, patients will be enrolled across four cohorts of advanced or metastatic disease: * pancreatic ductal adenocarcinoma (PDAC) * ovarian cancer * triple negative breast cancer (TNBC) * other solid tumors

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	ORIC-101	ORIC-101 once daily, 5 or 7 days/week, for 21 days of each 28-day cycle
DRUG	Nab-paclitaxel	75 or 100 mg/m2 Days 1, 8, and 15 of each 28-day cycle

Timeline

• Start date: 2019-05-02
• Primary completion: 2022-09-22
• Completion: 2023-12-04
• First posted: 2019-04-26
• Last updated: 2023-12-15

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study