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Study of ORIC-114 in Patients With Advanced Solid Tumors Harboring an EGFR or HER2 Alteration

ConditionSolid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorORIC Pharmaceuticals

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically or cytologically confirmed locally advanced or metastatic solid tumor with a documented EGFR or HER2 exon 20 insertion mutation or atypical EGFR mutation as determined by any nucleic acid-based diagnostic testing method, or HER2 amplification/overexpression as determined by an immunohistochemistry (IHC) or an in situ hybridization (ISH) test

Part I Dose Escalation (CLOSED) Any solid tumor with

EGFR exon 20 insertion mutation

HER2 exon 20 insertion mutation

Disqualifiers

Known EGFR T790M mutation

Leptomeningeal disease and spinal cord compression

History of class III or IV congestive heart failure or severe non-ischemic cardiomyopathy, unstable or poorly controlled angina, myocardial infarction, or ventricular arrhythmia within the previous 6 months

Past medical history of interstitial lung disease (ILD), drug induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD

Trial design

Design model

Sequential

Treatments tested in this trial

  • ORIC-114

    Drug

    ORIC-114 oral daily

  • Chemotherapy drug

    Drug

    21 days for up to 4 cycles

Treatment groups

350 Participants
are divided into 2 treatment groups
Group A: Dose Escalation and Dose OptimizationExperimental treatment 1 intervention
Group B: Combination Dose EscalationExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Recommended Phase 2 Dose (RP2D)

RP2D as determined by interval 3+3 dose escalation design

Time frame
12 months
2

Maximum plasma concentration (Cmax)

PK of ORIC-114

Time frame
28 Days
3

Time of maximum observed concentration (Tmax)

PK of ORIC-114

Time frame
28 Days
4

Area under the curve (AUC)

PK of ORIC-114

Time frame
28 Days

Secondary outcomes

1

Objective response rate (ORR)

Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Time frame
36 months
2

Duration of response (DOR)

Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Time frame
36 months
3

Clinical benefit rate (CBR)

Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Time frame
36 months
4

Progression-free survival (PFS)

Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Time frame
36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ORIC Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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