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

Part of paid clinical trials in New York, New York.

Sponsor
ORIC Pharmaceuticals
Study ID
NCT06816992
Phase
PHASE1
Status
Recruiting
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Conditions

  • EGFR Exon 20 Insertion Mutations
  • EGFR-mutated NSCLC
  • NSCLC
  • Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Feb 27, 2025
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
76 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 Dose Escalation level 1
    ORIC-114 + amivantamab
  • Experimental: Part 1 Dose Escalation level 2
    ORIC-114 + amivantamab
  • Experimental: Part 1 Dose Escalation level 3
    ORIC-114 + amivantamab
  • Experimental: Part 2 Dose Expansion
    Two potential ORIC-114 dose levels + amivantamab

Primary Outcome Measure

Recommended Phase 2 Dose (RP2D) [ Time Frame: 12 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-
Virginia Cancer SpecialistsFairfaxVirginia22031-

Find similar trials in New York, NY

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
NYU Langone Health· New York, NYVirginia Cancer Specialists· Fairfax, VA

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