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Trial Title: A Study of NX-019 in Patients With Advanced, Epidermal Growth Factor Receptor (EGFR) Mutant Cancer

NCT ID: NCT05514496

Condition: EGFR Mutation-Related Tumors

Conditions: Keywords:
NX-019
EGFR Mutant Cancer
CNS Metastasis

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: NX-019
Description: NX-019 will be administered orally.
Arm group label: Part 1: NX-019 Dose Escalation
Arm group label: Part 2: NX-019 Dose Expansion

Summary: This is a 2-part, first-in-human, open-label study to determine the safety and tolerability of NX-019 and preliminary efficacy in patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutant cancer.

Detailed description: Part 1: The primary objective of Part 1 of this study is to evaluate the safety and tolerability of NX-019 and to determine the maximum tolerated dose (MTD)/Recommended Expansion Dose(s) (REDs). Part 2: The primary objective of Part 2 of this study is to confirm the safety and tolerability of NX-019 at the REDs and, for each expansion cohort, the preliminary evidence of efficacy as measured by objective response rate (ORR).

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: City of Hope Comprehensive Cancer Center - Duarte

Address:
City: Duarte
Zip: 91010
Country: United States

Status: Recruiting

Facility:
Name: City of Hope - Huntington Beach

Address:
City: Huntington Beach
Zip: 92648
Country: United States

Status: Recruiting

Facility:
Name: City of Hope Orange County Lennar Foundation Cancer Center

Address:
City: Irvine
Zip: 92618
Country: United States

Status: Recruiting

Facility:
Name: HealthPartners Frauenshuh Cancer Center

Address:
City: Saint Louis Park
Zip: 55426
Country: United States

Status: Recruiting

Facility:
Name: HealthPartners Cancer Center at Regions Hospital

Address:
City: Saint Paul
Zip: 55101
Country: United States

Status: Recruiting

Facility:
Name: University Of Virginia Comprehensive Cancer Center

Address:
City: Charlottesville
Zip: 22903
Country: United States

Status: Recruiting

Facility:
Name: NEXT Virginia

Address:
City: Fairfax
Zip: 22031
Country: United States

Status: Recruiting

Facility:
Name: Seoul National University Hospital

Address:
City: Seoul
Zip: 03080
Country: Korea, Republic of

Status: Recruiting

Facility:
Name: Severance Hospital

Address:
City: Seoul
Zip: 03722
Country: Korea, Republic of

Status: Recruiting

Facility:
Name: Asan Medical Center

Address:
City: Seoul
Zip: 05505
Country: Korea, Republic of

Status: Recruiting

Facility:
Name: Samsung Medical Center

Address:
City: Seoul
Zip: 06351
Country: Korea, Republic of

Status: Recruiting

Facility:
Name: National Taiwan University Cancer Center

Address:
City: Taipei City
Zip: 10002
Country: Taiwan

Status: Recruiting

Start date: October 5, 2022

Completion date: October 17, 2027

Lead sponsor:
Agency: Nalo Therapeutics Inc.
Agency class: Industry

Source: Nalo Therapeutics Inc.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05514496

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