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Dose Escalation for Solid Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Solid TumorsORIC-114 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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), preliminary antitumor ORIC-114 when administered to patients with advanced solid tumors harboring an EGFR or HER2 alteration.

Eligible Conditions
  • Solid Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

5 Primary · 6 Secondary · Reporting Duration: 36 months

12 months
Recommended Phase 2 Dose (RP2D)
28 Days
Apparent plasma terminal elimination half-life (t1/2)
Area under the curve (AUC)
Maximum plasma concentration (Cmax)
Time of maximum observed concentration (Tmax)
36 months
Clinical benefit rate (CBR)
Duration of response (DOR)
Intracranial progression-free survival (PFS)
Intracranial response rate (CR and/or PR)
Objective response rate (ORR)
Progression-free survival (PFS)

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Neratinib at RP2D
1
WTX-330 dose escalation
1
Debio 0123

Trial Design

1 Treatment Group

Dose Escalation
1 of 1

Experimental Treatment

42 Total Participants · 1 Treatment Group

Primary Treatment: Dose Escalation · No Placebo Group · Phase 1

Dose Escalation
Drug
Experimental Group · 1 Intervention: ORIC-114 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 36 months

Who is running the clinical trial?

ORIC PharmaceuticalsLead Sponsor
6 Previous Clinical Trials
410 Total Patients Enrolled
Pratik S. Multani, MD, MSStudy DirectorORIC Pharmaceuticals
1 Previous Clinical Trials
1 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a confirmed advanced or spreading solid tumor with an EGFR or HER2 exon 20 insertion mutation, or evidence of HER2 amplification/overexpression as shown in IHC or ISH testing.
You have already received and made progress on available standard treatments, and additional conventional treatment is deemed inappropriate or intolerable.
NSCLC patients must have received platinum-based chemotherapy or an alternative therapy if platinum is not suitable.
You have a central nervous system disorder that has been managed or is symptomless.
Your Eastern Cooperative Oncology Group performance status is 0 or 1.
Your disease can be objectively measured using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
You must be willing to consent and have a biopsy prior to treatment.
You must exhibit satisfactory organ functioning.
References

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