A Study of NX-019 in Patients With Advanced, Epidermal Growth Factor Receptor (EGFR) Mutant Cancer
- Conditions
- EGFR Mutation-Related Tumors
- Registration Number
- NCT05514496
- Lead Sponsor
- Nalo Therapeutics Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 258
Inclusion Criteria:<br><br> - Histologically confirmed, locally advanced, or metastatic EGFR-mutant cancer and has<br> progressed on or are intolerant to all standard therapy.<br><br> - Patients with non-small cell lung cancer (NSCLC) harboring a mutation that is<br> sensitive to osimertinib must have received osimertinib prior to enrollment.<br><br> - Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1<br> (evaluable disease acceptable for dose escalation part of study).<br><br> - =18 years of age (or age of consent in in accordance with local law).<br><br> - Life expectancy =3 months.<br><br> - Adequate organ and bone marrow function.<br><br> - All patients will have a baseline magnetic resonance imaging (MRI) of the brain.<br><br> - Resolution of any clinically significant toxic effects of prior therapy to Grade 0<br> or 1 according to the National Cancer Institute CTCAE v5.0 (exception of alopecia<br> and Grade 2 peripheral neuropathy).<br><br> - Eastern Cooperative Oncology Group (ECOG) performance status of =2.<br><br> - Willingness of men and women of reproductive potential to observe conventional and<br> effective birth control methods with failure rates of <1% for the duration of<br> treatment and for 6 months following the last dose of study treatment.<br><br> - A negative serum pregnancy test at Screening and a negative (serum or urine)<br> pregnancy test within 72 hours before the first dose of study drug (female patients<br> of childbearing potential only).<br><br> - Willing and able to give informed consent and comply with protocol requirements for<br> the duration of the study.<br><br>Specific Inclusion Criteria for Expansion Cohorts:<br><br>To be eligible during the expansion part of the study, patients must meet the above<br>inclusion criteria, and the criteria for 1 of the following cohorts:<br><br>Expansion Cohort 1:<br><br> - Patients with NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations who have<br> progressed on or after prior EGFR TKI therapy.<br><br>Expansion Cohort 2:<br><br> - Patients with NSCLC with EGFR ex20ins mutations, who are not suitable for, or are<br> unwilling to receive available ex20ins mutation targeted therapy.<br><br>Expansion Cohort 3:<br><br> - Patients with NSCLC with EGFR mutations for which there is no current targeted<br> therapy, (i.e., exclusion of exon 19, exon 21 L858R, and ex20ins mutation).<br><br>Exclusion Criteria:<br><br>Patients who meet any of the following criteria will be excluded from participation in<br>the study:<br><br> - Known C797X EGFR mutations or 1 or more known secondary drivers of disease.<br><br> - Disease requiring immediate palliative treatment with surgery or radiation therapy.<br><br> - Requirement for greater than 4 mg/day of dexamethasone (or equivalent) for<br> management of CNS metastases.<br><br> - Received systemic anticancer chemotherapy, targeted agents, antibody therapy for<br> cancer, immunotherapy for cancer, hormonal therapy or an investigational agent<br> within 2 weeks or 5 half-lives (whichever is shorter) prior to start of study drug<br> treatment.<br><br> - Major surgery within 3 weeks prior to start of study drug treatment.<br><br> - Radiation therapy within 4 weeks prior to start of study drug treatment.<br><br> - Severe or unstable cardiac conditions within 6 months prior to starting study drug<br> treatment.<br><br> - Severe or unstable medical condition including uncontrolled diabetes or unstable<br> psychiatric condition.<br><br> - Dependent on contact lenses (unable to wear eyeglasses) and unable to comply with<br> ophthalmic guidance.<br><br> - History of interstitial lung disease, radiation pneumonitis which required systemic<br> steroid therapy, or other significant lung disease.<br><br> - Another active malignancy within the previous 2 years except for localized cancers<br> that are not related to the current cancer being treated, are considered cured, and,<br> in the opinion of the Investigator, present a low risk of recurrence.<br><br> - Active infection requiring systemic therapy.<br><br> - Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) (i.e., hepatitis B<br> surface antigen-positive), or hepatitis C virus (HCV) (i.e., detectable HCV<br> ribonucleic acid [RNA]).<br><br> - Active gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short<br> gut syndrome) or conditions that may impact drug absorption.<br><br> - Pregnant or breastfeeding.<br><br> - Is using a strong CYP3A inhibitor or inducer, and cannot refrain from use from 7<br> days prior to the first dose and throughout the study.<br><br> - Is using a proton pump inhibitor and cannot refrain from use from 7 days prior to<br> the first dose and throughout the study.<br><br> - Is using a sensitive substrate of P-gp with a narrow therapeutic window (e.g.<br> digoxin).<br><br> - Any other condition, including significant skin or nail disease, that in the opinion<br> of the Investigator would place the patient at an unacceptable risk or cause the<br> patient to be unlikely to fully participate or comply with study procedures.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Part 1 and Part 2: Incidence of Treatment-emergent Adverse Events (TEAEs);Part 1 and Part 2: Incidence of Adverse Events of Special Interest (AESIs);Part 1 and Part 2: Incidence of Serious Adverse Events (SAEs);Part 2: Objective Response Rate
- Secondary Outcome Measures
Name Time Method