RecruitingPhase 1

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

United States, Australia, Canada76 participantsStarted 2025-02-27

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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

What they're measuring

Recommended Phase 2 Dose (RP2D)

Timeframe: 12 months

Objective response rate (ORR)

Timeframe: 12 months

Duration of response (DOR)

Timeframe: 12 months

Progression-free survival (PFS)

Timeframe: 12 months

Trial details

NCT IDNCT06816992

SponsorORIC Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

ORIC Clinical

650-388-5600 clinical@oricpharma.com

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