NCT04033328 is a Phase 1 clinical trial of ORIC-101 in Prostatic Neoplasms, sponsored by ORIC Pharmaceuticals.

Who is sponsoring NCT04033328?

NCT04033328 is sponsored by ORIC Pharmaceuticals.

What drugs are being tested in NCT04033328?

Interventions in NCT04033328: ORIC-101, enzalutamide 40 MG oral capsule [Xtandi].

What condition does NCT04033328 study?

NCT04033328 studies Prostatic Neoplasms.

Is NCT04033328 still recruiting?

NCT04033328 is currently terminated. Last updated 15 December 2023.

Last reviewed 2023-12-15 · How we verify

NCT04033328

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of ORIC-101 in Combination With Enzalutamide

Terminated Phase 1 Last updated 15 December 2023

What this trial tests

Phase 1 trial testing ORIC-101 in Prostatic Neoplasms in 41 participants. Terminated before completion.

Timeline

28 October 2019

Primary endpoint
22 November 2022

4 December 2023

Quick facts

Lead sponsor	ORIC Pharmaceuticals
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	41
Start date	28 October 2019
Primary completion	22 November 2022
Estimated completion	4 December 2023
Sites	3 locations across United States

Drugs / interventions tested

ORIC-101 — full drug profile →
enzalutamide 40 MG oral capsule [Xtandi] — full drug profile →

Conditions studied

Prostatic Neoplasms — all drugs for Prostatic Neoplasms →

Sponsor

ORIC Pharmaceuticals — full company profile →

Who can join

18 and older, male only, with Prostatic Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Innovative trial design in precision oncology.
Tsimberidou AM, Müller P, Ji Y. · · 2022 · cited 14× · PMID 33022355 · DOI 10.1016/j.semcancer.2020.09.006
Phase I Study of ORIC-101, a Glucocorticoid Receptor Antagonist, in Combination with Enzalutamide in Patients with Metastatic Castration-resistant Prostate Cancer Progressing on Enzalutamide.
Abida W, Hahn AW, Shore N, Agarwal N, et al · · 2024 · cited 12× · PMID 38226958 · DOI 10.1158/1078-0432.ccr-23-3508
Psychosocial Stress, Glucocorticoid Signaling, and Prostate Cancer Health Disparities in African American Men.
Woods-Burnham L, Stiel L, Martinez SR, Sanchez-Hernandez ES, et al · · 2020 · cited 8× · PMID 35252767
Emerging frontiers in androgen receptor research for prostate Cancer: insights from the 2nd international androgen receptor Symposium.
Israel JS, Marcelin LM, Thomas C, Szczyrbová E, et al · · 2024 · cited 6× · PMID 39014480 · DOI 10.1186/s13046-024-03125-5
Redefining cancer care: harnessing circulating tumor cells' potential for improved diagnosis and prognosis.
Janjua D, Chaudhary A, Joshi U, Tripathi T, et al · · 2025 · cited 4× · PMID 40676582 · DOI 10.1186/s12935-025-03883-y

Verify or expand the search:

Other trials of ORIC-101

Trials testing the same drug.

NCT03928314 — Study of ORIC-101 in Combination With Anticancer Therapy · Phase 1 · terminated
NCT03835637 — Single and Multiple Dose Study of ORIC-101 in Adult Healthy Subjects · Phase 1 · completed
NCT03324555 — Study of ORIC-101 in Healthy Adult Subjects · Phase 1 · completed

Other recruiting trials for Prostatic Neoplasms

Currently open trials in the same condition.

NCT07285057 — Diagnostic Utility of rhPSMA-7.3 (18F) PET/CT in Men With Prostate Cancer on Active Surveillance · Phase 2 · recruiting
NCT07319871 — A Study of Pasritamig (JNJ-78278343) in Combination With JNJ-86974680 for Treatment of Prostate Cancer · Phase 1 · recruiting
NCT07335224 — Men With Prostate Cancer: Optimizing Wellness by Enhanced Relief From Hot Flashes With Acupuncture · NA · recruiting
NCT07451002 — A Study to Assess Adherence to Apalutamide in Metastatic Hormone-Sensitive Prostate Cancer Participants in France · recruiting
NCT06547398 — Prostate Adaptive Radiation Therapy · NA · recruiting

Other ORIC Pharmaceuticals trials

Trials by the same sponsor.

NCT06012721 — Effect of Food on the Pharmacokinetics of ORIC-114 · Phase 1 · completed
NCT05227144 — Study of ORIC-533 in Relapsed or Refractory Multiple Myeloma · Phase 1 · completed
NCT03928314 — Study of ORIC-101 in Combination With Anticancer Therapy · Phase 1 · terminated
NCT03835637 — Single and Multiple Dose Study of ORIC-101 in Adult Healthy Subjects · Phase 1 · completed
NCT03324555 — Study of ORIC-101 in Healthy Adult Subjects · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04033328 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by ORIC Pharmaceuticals
Last refreshed: 15 December 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04033328.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing