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Study of ORIC-114 in Patients with Advanced Solid Tumors Harboring an EGFR or HER2 Alteration
The purpose of this study is to establish the recommended Phase 2 dose (RP2D) and/or maximum tolerated dose (MTD), safety, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of ORIC-114 as a Single Agent or in Combination with Chemotherapy when administered to patients with advanced solid tumors harboring an EGFR or HER2 alteration.
Study details:
ORIC-114 is a brain penetrant, selective, orally bioavailable, irreversible small molecule inhibitor designed to target EGFR and HER2 alterations, making it a promising therapeutic candidate for development in patients whose tumors harbor these alterations, including those with CNS metastases. This is a first-in-human, open-label, single arm, multicenter, dose escalation study of ORIC-114 as a single agent (Part I), followed by dose optimization (Part II) to establish the recommended phase 2 dose (RP2D) and antitumor activity of ORIC-114 in patients with advanced solid tumors harboring an EGFR or HER2 alteration who have exhausted available treatment options. After the optimal RP2D has been determined, Phase 2 will be initiated via protocol amendment to add one or more expansion cohorts of patients with specific tumor types, treatment history, and/or expression of a specific biomarker to evaluate the antitumor activity of ORIC-114.
After completion of Part I dose escalation, Part III, a dose escalation study of ORIC-114 in combination with chemotherapy (carboplatin-pemetrexed) may be initiated to establish the RP2D and/or MTD and antitumor activity for the combination (US sites only).
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2022-03-10
Primary completion: 2025-03-01
Study completion finish: 2026-03-01
Study type
TREATMENT
Phase
PHASE1
PHASE2
Trial ID
NCT05315700
Intervention or treatment
DRUG: ORIC-114
DRUG: Chemotherapy drug
Conditions
- • Solid Tumors
Find a site
Closest Location:
Peter MacCallum Cancer Centre
Research sites nearby
Select from list below to view details:
Peter MacCallum Cancer Centre
Melbourne, Not Specified, Australia
Chris O'Brien Lifehouse
Camperdown, Not Specified, Australia
One Clinical Research, Hollywood Medical Centre
Nedlands, Not Specified, Australia
Sydney Adventist Health
Sydney, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Dose Escalation and Dose Optimization
| DRUG: ORIC-114
|
EXPERIMENTAL: Combination Dose Escalation
| DRUG: ORIC-114
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Recommended Phase 2 Dose (RP2D) | RP2D as determined by interval 3+3 dose escalation design | 12 months |
Maximum plasma concentration (Cmax) | PK of ORIC-114 | 28 Days |
Time of maximum observed concentration (Tmax) | PK of ORIC-114 | 28 Days |
Area under the curve (AUC) | PK of ORIC-114 | 28 Days |
Apparent plasma terminal elimination half-life (t1/2) | PK of ORIC-114 | 28 Days |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Objective response rate (ORR) | Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 | 36 months |
Duration of response (DOR) | Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 | 36 months |
Clinical benefit rate (CBR) | Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 | 36 months |
Progression-free survival (PFS) | Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 | 36 months |
Intracranial response rate (CR and/or PR) | Modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 | 36 months |
Intracranial progression-free survival (PFS) | Modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 | 36 months |
Frequently Asked Questions
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