NCT04033328

Study of ORIC-101 in Combination With Enzalutamide

An Open-Label Phase 1b Study of ORIC-101 in Combination With Enzalutamide in Patients With Metastatic Prostate Cancer Progressing on Enzalutamide

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: ORIC Pharmaceuticals · Industry
• Sex: Male
• 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 enzalutamide (Xtandi®) when administered to patients with metastatic prostate cancer progressing on enzalutamide.

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, single arm, multicenter, dose escalation followed by dose expansion study to assess the safety and preliminary antitumor activity of ORIC-101 in combination with enzalutamide in patients progressing on enzalutamide. Patients deemed eligible will receive treatment with ORIC-101 in addition to continuing their current enzalutamide therapy. Escalating dose levels of ORIC-101 will be administered orally, once daily in combination with enzalutamide 160 mg. Parallel enrollment for assessment of PK/PD modulation in up to 3 additional patients presenting with tumors expressing high levels of GR (GR-high) may be performed at each dose level after the dose level has cleared the initial dose-limiting toxicity evaluation period; these additional patients may serve as supplemental patients for selection of the maximum tolerated dose and/or RP2D. Dose expansion will further evaluate the safety and preliminary antitumor activity of ORIC-101 in patients presenting with different levels of GR expressing-tumors.

Conditions

• Prostatic Neoplasms

Interventions

Type	Name	Description
DRUG	ORIC-101	ORIC-101 once daily in each 28-day cycle
DRUG	enzalutamide 40 MG oral capsule [Xtandi]	160 mg once daily in each 28-day cycle

Timeline

• Start date: 2019-10-28
• Primary completion: 2022-11-22
• Completion: 2023-12-04
• First posted: 2019-07-26
• Last updated: 2023-12-15

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study