ORIC-114 for Solid Tumors

Recruiting at 35 trial locations

Overseen By ORIC Clinical

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: ORIC Pharmaceuticals

Disqualifiers: EGFR T790M mutation, ILD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

350 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests ORIC-114, a new oral medicine for advanced cancers. It targets proteins that help cancer grow, including in the brain, and is for patients who need new treatment options.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research Team

Pratik S. Multani, MD, MS

Principal Investigator

ORIC Pharmaceuticals

Eligibility Criteria

This trial is for adults with advanced solid tumors that have specific changes in genes called EGFR or HER2. Participants must have tried standard treatments without success and be able to undergo a biopsy. They should not have serious lung conditions, active gastrointestinal diseases, recent heart issues, known infections like hepatitis B or C, HIV, or any uncontrolled medical conditions.

Inclusion Criteria

My organs are functioning well.

My cancer has specific genetic changes in EGFR or HER2.

My brain involvement is either treated and stable or not treated but without symptoms.

Exclusion Criteria

I have an active infection needing treatment or a history of hepatitis B or C, but if I have hepatitis B, my virus levels are normal.

I have had lung conditions that needed steroid treatment.

My cancer has the EGFR T790M mutation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation (Part I)

ORIC-114 is administered as a single agent to determine the recommended Phase 2 dose (RP2D) and maximum tolerated dose (MTD)

28 days

Continuous once daily dosing regimen

Dose Optimization (Part II)

Dose optimization to establish the RP2D and evaluate antitumor activity of ORIC-114

12 months

Combination Dose Escalation (Part III)

ORIC-114 is administered in combination with chemotherapy (carboplatin-pemetrexed) to establish the RP2D and/or MTD

21 days

Continuous once daily dosing regimen

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

Treatment Details

Interventions

• ORIC-114

Trial Overview ORIC-114 is being tested either alone or with chemotherapy to find the safest and most effective dose for treating solid tumors with EGFR or HER2 alterations. The study will look at how well it works (its antitumor activity), its safety profile, and how the body processes it.

Participant Groups

Group I: Dose Escalation and Dose Optimization Experimental Treatment 1 Intervention

ORIC-114 dosed orally on a continuous once daily dosing regimen in 28-day cycles.

Group II: Combination Dose Escalation Experimental Treatment 2 Interventions

ORIC-114 dosed orally on a continuous once daily dosing regimen in 21-day cycles.

Who Is Running the Clinical Trial?

ORIC Pharmaceuticals

Lead Sponsor

Trials

9

Recruited

970+