Solid Tumors / ORIC-114 / Chemotherapy drug · Phase 1/2 Trial

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

ClinicalTrials.gov · September 4, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registry record describing a planned Phase 1/2 trial of ORIC-114 in patients with EGFR or HER2-altered solid tumors, currently recruiting. No efficacy, safety, or pharmacokinetic results are reported here; the record lists the intended primary endpoints (RP2D/MTD, PK parameters) and study structure only.

What was studied

Phase 1/2, Interventional, Non Randomized, Sequential, Open label, Treatment purpose. Solid Tumors; age from 18 Years. Intervention: Dose Escalation and Dose Optimization; Combination Dose Escalation. n = 350. 42 sites across 10 countries.

Key findings

Safety

This is a registry record only; no results, efficacy data, or safety outcomes are reported. Primary endpoints are dose-finding (RP2D/MTD) and pharmacokinetics, not clinical efficacy.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

Early-phase trial (Phase 1/2) with no reported results; registry record describes planned study design and endpoints only, typical of first-in-human or dose-escalation work.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Recommended Phase 2 Dose (RP2D) (assessed at 12 months); Maximum plasma concentration (Cmax) (assessed at 28 Days); Time of maximum observed concentration (Tmax) (assessed at 28 Days); Area under the curve (AUC) (assessed at 28 Days); Apparent plasma terminal elimination half-life (t1/2) (assessed at 28 Days)

DesignPhase 1/2, Interventional, Non Randomized, Sequential, Open label, Treatment purpose

PopulationSolid Tumors; age from 18 Years

Sample size350

InterventionDose Escalation and Dose Optimization; Combination Dose Escalation

Setting42 sites across 10 countries

Reported figures

Quoted from the source exactly as published.

Planned enrollment350

Study phasePhase 1/2

Primary outcome measure (dose-finding)Recommended Phase 2 Dose (RP2D) at 12 months

Primary outcome measure (pharmacokinetics)Cmax, Tmax, AUC, t1/2 at 28 days

Caveats

This is a registry record only; no results, efficacy data, or safety outcomes are reported.
Recruitment status is 'RECRUITING'—study is ongoing and no endpoint data are available.
Primary endpoints are dose-finding (RP2D/MTD) and pharmacokinetics, not clinical efficacy.
Antitumor activity is listed as an objective but is not a primary outcome measure.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 1/2 design with single-agent and combination arms planned.

Directness

moderate

Primary endpoints include dose-finding (RP2D/MTD) and PK; antitumor activity is secondary.

Consistency

insufficient

Registry record only; no results reported to assess consistency.

Risk of bias

insufficient

Planned study; no conduct or outcome data available to assess bias.

Sample adequacy

moderate

Estimated enrollment 350 participants across Phase 1/2; adequate for early-phase dose-escalation.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT05315700). This is a study registration, not published results. Lead sponsor: ORIC Pharmaceuticals. Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 350 participants (ESTIMATED). Conditions: Solid Tumors. Interventions: DRUG: ORIC-114; DRUG: Chemotherapy drug. Primary outcome measures: Recommended Phase 2 Dose (RP2D) , 12 months; Maximum plasma concentration (Cmax) , 28 Days; Time of maximum observed concentration (Tmax) , 28 Days; Area under the curve (AUC) , 28 Days; Apparent plasma terminal elimination half-life (t1/2) , 28 Days. Brief summary: 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Solid TumorsNCT05315700ORIC-114Chemotherapy drugORIC Pharmaceuticals