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An Open-Label, Phase 1/2 Study of ORIC-114 as a Single Agent or in Combination With Chemotherapy, in Patients With Advanced Solid Tumors Harboring an EGFR or HER2 Alteration

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Trial Profile

An Open-Label, Phase 1/2 Study of ORIC-114 as a Single Agent or in Combination With Chemotherapy, in Patients With Advanced Solid Tumors Harboring an EGFR or HER2 Alteration

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 15 May 2024

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At a glance

  • Drugs Carboplatin (Primary) ; ORIC 114 (Primary) ; Pemetrexed (Primary)
  • Indications Advanced breast cancer; Brain metastases; CNS cancer; HER2 positive breast cancer; Male breast cancer; Non-small cell lung cancer; Solid tumours
  • Focus First in man; Pharmacokinetics; Registrational
  • Sponsors ORIC Pharmaceuticals

    • Most Recent Events

    • 15 Apr 2024 According to an ORIC Pharmaceuticals media release, first patients dosed across three expansion cohorts, the expansion cohorts have now been initiated in patients with non-small cell lung cancer (NSCLC) with EGFR exon 20 (EGFR exon 20 inhibitor naive), HER2 exon 20, or EGFR atypical mutations. The company also announced the initiation of an extension cohort for the treatment of patients with first-line, treatment-naive EGFR exon 20 NSCLC.
    • 15 Apr 2024 According to an ORIC Pharmaceuticals media release, company announced completion of does-escalation portion phase 1b. Based upon these data, ORIC selected the two provisional recommended Phase 2 dose (RP2D) levels of ORIC-114 at 80 mg and 120 mg QD, which are being further evaluated in three dose expansion cohorts for dose optimization and final RP2D selection.
    • 08 Jan 2024 According to an ORIC Pharmaceuticals media release, initiation of multiple dose expansion cohorts for ORIC-114 in patients with mutated NSCLC expected in first half of 2024 and updated Phase 1b data expected in first half of 2025
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