ORIC-114 for Advanced solid tumors with EGFR or HER2 alteration

Inclusion criteria

• {"criterion_text":"- Aged ≥18 years at the time of signing the informed consent"}
• {"criterion_text":"- Histologically or cytologically confirmed locally advanced or metastatic solid tumor with a documented EGFR or HER2 exon 20 insertion mutation or atypical EGFR mutation as described in the protocol."}
• {"criterion_text":"- Prior Therapies as described in the protocol."}
• {"criterion_text":"- Agreement and ability to undergo pretreatment biopsy, provided the procedure is clinically feasible and not deemed unsafe by the investigator"}
• {"criterion_text":"- Measurable disease according to RECIST 1.1"}
• {"criterion_text":"- Patients with CNS involvement, which is either previously treated and controlled or untreated and asymptomatic are eligible."}
• {"criterion_text":"- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the study drug are eligible."}
• {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1."}
• {"criterion_text":"- Adequate organ function as defined by the criteria included in the protocol."}
• {"criterion_text":"- Able to swallow oral medication without chewing or crushing."}
• {"criterion_text":"- Women of childbearing potential must have a negative serum pregnancy test within 72 hours before starting study treatment."}
• {"criterion_text":"- Women of childbearing potential and men who are not surgically sterile must agree to use highly effective medically accepted method of birth control during the study and for 90 days after end of treatment."}
• {"criterion_text":"- Willing and able to give informed consent and comply with protocol requirements for the duration of the study."}

Exclusion criteria

• {"criterion_text":"- Patients with known EGFR T790M mutation."}
• {"criterion_text":"- Known active infection requiring treatment or history of hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients positive for HbsAg but normal HBV DNA level are allowed. Testing is not required in the absence of history."}
• {"criterion_text":"- Active gastrointestinal disease (eg, Crohn’s disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would reasonably impact drug absorption."}
• {"criterion_text":"- Any other concurrent serious uncontrolled medical, psychological, or addictive conditions that, in the opinion of the investigator, may interfere with protocol compliance or contraindicates participation in the study."}
• {"criterion_text":"- Current participation in another clinical study of an investigational agent, vaccine, or device; concomitant participation in observational studies is acceptable after sponsor approval."}
• {"criterion_text":"- Leptomeningeal disease (LMD) and spinal cord compression."}
• {"criterion_text":"- Treated with any other anticancer therapy or herbal (alternative) medicines within 14 days or 5 half-lives (whichever is shorter) prior to the first dose of study drug."}
• {"criterion_text":"- Radiotherapy within 2 weeks prior to first dose of study drug (palliative radiation or stereotactic radiosurgery within 7 days prior to first dose of study drug); patients must have recovered from all radiotherapy-related toxicities."}
• {"criterion_text":"- Major surgery within 21 days prior to first dose of study drug or incomplete recovery from adverse effects resulting from such procedure."}
• {"criterion_text":"- History of class III or IV congestive heart failure or severe non-ischemic cardiomyopathy, unstable or poorly controlled angina, myocardial infarction, or ventricular arrhythmia within the previous 6 months of first dose of study."}
• {"criterion_text":"- Past medical history of interstitial lung disease (ILD), drug induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD."}
• {"criterion_text":"- Known human immunodeficiency virus (HIV) infection, unless patient is healthy and has a low risk of AIDS-related outcomes."}

Primary endpoints

• {"endpoint_text":"- Part I: Provisional RP2Ds and/or MTD of ORIC-114.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Part II: Optimal ORIC-114 RP2D.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Part III: RP2D and/or MTD of ORIC-114 in combination with carboplatin-pemetrexed","definition_or_measurement_approach":""}
• {"endpoint_text":"- Incidence of adverse events, vital signs, evaluation of clinical laboratory results, 12-lead electrocardiogram (ECG), and other clinical assessments.","definition_or_measurement_approach":"Incidence and assessment of AEs and clinical safety by vital signs, lab results, and 12-lead ECG as recorded during study assessments."}
• {"endpoint_text":"- PK profile as measured by Tmax, Cmax, Clast, AUClast, AUCtau, AUCinf, Kel, t1/2, CL/F, Vz/F, Rac(Cmax), and Rac(AUC) as appropriate","definition_or_measurement_approach":"Pharmacokinetic parameters measured: Tmax, Cmax, Clast, AUClast, AUCtau, AUCinf, Kel, t1/2, CL/F, Vz/F, Rac(Cmax), Rac(AUC)."}

Secondary endpoints

• {"endpoint_text":"- Assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 • Objective response rate (ORR) (complete response [CR] or partial response [PR]), measured as changes in target and non-target lesions relative to baseline every 8 weeks • Duration of response (DOR), defined as time of first response to first documentation of radiographic progression or death, whichever occurs first.","definition_or_measurement_approach":"Tumor response per RECIST 1.1 measured every 8 weeks; DOR defined from first response to radiographic progression or death."}
• {"endpoint_text":"- • Clinical benefit rate (CBR) (CR, PR, or stable disease [SD] ≥6 months) • Progression-free survival (PFS), defined as time from first dose of ORIC-114 to first documentation of radiographic progression or death, whichever occurs first","definition_or_measurement_approach":"CBR = CR/PR/SD ≥6 months; PFS measured from first dose to radiographic progression or death."}
• {"endpoint_text":"- Intracranial response will be assessed according to modified RECIST 1.1 and/or RANO-BM • Intracranial response rate (CR or PR) measured as changes in target and non-target CNS lesions • Intracranial PFS, defined as time from first dose of ORIC-114 to first documentation of radiographic progression in the brain or death, whichever occurs first.","definition_or_measurement_approach":"Intracranial response per modified RECIST 1.1 and/or RANO-BM; intracranial PFS measured from first dose to brain progression or death."}

Poland

Earliest CTIS Part Ii Submission Date

09-08-2024

Latest Decision Or Authorization Date

18-05-2025

Processing Time Days

282

Number Of Sites

1

Number Of Participants

10

Spain

Earliest CTIS Part Ii Submission Date

02-10-2024

Latest Decision Or Authorization Date

14-05-2025

Processing Time Days

224

Number Of Sites

3

Number Of Participants

20

Primary sponsor

Full Name

ORIC Pharmaceuticals Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Syneos Health Inc.

Responsibilities

sponsorDuties codes: 1,10,11,12,2,5,6,7,8,9; operational and study support (contact: gurveen.saberwal@syneoshealth.com)

Third parties

• {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"sponsorDuties codes: 1,10,11,12,2,5,6,7,8,9; contact gurveen.saberwal@syneoshealth.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medpace Reference Laboratories LLC","duties_or_roles":"sponsorDuties codes: 4; contact s.hou@medpace.com","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: 7; contact info@medidata.com","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"sponsorDuties codes: 3; contact crickard@suvoda.com","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"sponsorDuties: 15; value: Independent Central Review of Imaging; contact Jenna.Struzik@clario.com","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"sponsorDuties codes: 4; contact jodegaard@guardanthealth.com","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Labconnect LLC","duties_or_roles":"sponsorDuties: 15; value: Central lab for providing lab kits and sample storage; contact amerza@labconnect.com","organisation_type":"Laboratory/Research/Testing facility"}