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ORIC-114 in Combination With Subcutaneous Amivantamab in Patients With EGFR Exon20 Insertion Mutant NSCLC

ConditionsSolid TumorsEGFR Exon 20 Insertion MutationsNSCLCEGFR-mutated NSCLC
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorORIC Pharmaceuticals

About this trial

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-114 in combination with subcutaneous (SC) amivantamab in patients with advanced or metastatic NSCLC harboring an EGFR exon 20 insertion mutation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically or cytologically confirmed metastatic NSCLC with a documented EGFR exon 20 insertion mutation as determined locally by any nucleic acid-based diagnostic testing method; all tests should be performed in a CLIA certified or equivalently accredited laboratory

Dose Escalation: Patients may have previously received and progressed on or after platinum-based chemotherapy or may be treatment naïve

Dose Expansion: Patients must not have received any prior therapy; at time of enrollment, patients must decline, or be ineligible for all available standard of care therapies with proven benefit

Agreement and ability to undergo a pretreatment biopsy, provided the procedure is clinically feasible and not deemed unsafe by the investigator

Disqualifiers

Known small cell lung cancer transformation

Leptomeningeal disease

Spinal cord compression not definitively treated with surgery or radiation

Prior immunotherapy

Trial design

Design model

Sequential

Treatments tested in this trial

  • ORIC-114 Dose 1 + amivantamab

    Drug

    ORIC-114 oral daily, amivantamab subcutaneous weekly for 4 weeks followed by every 4 week injection

  • ORIC-114 Dose 2 + amivantamab

    Drug

    ORIC-114 oral daily, amivantamab subcutaneous weekly for 4 weeks followed by every 4 week injection

  • ORIC-114 Dose 3 + amivantamab

    Drug

    ORIC-114 oral daily, amivantamab subcutaneous weekly for 4 weeks followed by every 4 week injection

Treatment groups

76 Participants
are divided into 4 treatment groups
Group A: Part 1 Dose Escalation level 1Experimental treatment 1 intervention
Group B: Part 1 Dose Escalation level 2Experimental treatment 1 intervention
Group C: Part 1 Dose Escalation level 3Experimental treatment 1 intervention
Group D: Part 2 Dose ExpansionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Recommended Phase 2 Dose (RP2D)

RP2D of ORIC-114 in combination with amivantamab by interval 3+3 dose escalation design

Time frame
12 months
2

Objective response rate (ORR)

Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Time frame
12 months
3

Duration of response (DOR)

Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Time frame
12 months
4

Progression-free survival (PFS)

Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Time frame
12 months

Secondary outcomes

1

Plasma PK parameters

Peak Plasma Concentration (Cmax)

Time frame
28 Days
2

Plasma PK parameters

Time of maximal plasma concentration (Tmax)

Time frame
28 Days
3

Plasma PK parameters

Area under the plasma concentration vs time curve (AUC)

Time frame
28 Days
4

Plasma PK parameters

Apparent plasma terminal elimination half-life (t1/2)

Time frame
28 Days

Other outcomes

Sponsors and contacts

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

ORIC Pharmaceuticals

Lead sponsor

Janssen Research and Development LLC

Collaborator

Source ClinicalTrials.gov
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