Assessing an Oral EGFR Inhibitor,YK-209A in Patients Who Have Advanced Non-small Cell Lung Cancer… (NCT05767866) | Clinical Trial Compass
UnknownPhase 1/2
Assessing an Oral EGFR Inhibitor,YK-209A in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR
China160 participantsStarted 2018-03-30
Plain-language summary
This study aimed to evaluate the safety and preliminary efficacy of YK-029A, a novel third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, in treated or untreated patients with advanced non-small cell lung cancer (NSCLC).
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Have histologically or cytologically confirmed locally advanced or metastatic NSCLC disease (Stage IIIB or IV) .
✓. Male or femal adult，be able to provide a signed and dated, written informed consent.
✓. Must have measurable disease by response evaluation criteria in solid tumors (RECIST) v1.1.
✓. Minimum life expectancy of 3 months or more.
✓. Adequate organ function at baseline.
✓. Normal QT interval on screening electrocardiogram (ECG), defined as QT interval corrected (Fridericia) (QTcF) of less than or equal to (≤ ) 450 millisecond (ms) in males or ≤ 470 ms in females.
✓. Refractory to standard available therapies.
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
Exclusion criteria
✕. Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days before screening.
✕. Radiotherapy with a limited field of radiation for palliation within 1 week of the first dose or with a wide field of radiation which must be completed within 4 weeks before screening.
✕. NSCLC patients with EGFR T790M mutation previously treated with third-generation EGFR-TKIs (such as AZD9291, CO-1686, HM61713, EGF816, PF-06747775, vometinib, BPI-15086, Ivirtinib maleate, etc.) and their apis or the same drugs in other clinical trials Drug treatment.
What they're measuring
1
Part 1: Number of Participants that Experience Adverse Events (AEs) and Serious Adverse Events (SAEs) .
Timeframe: Cycle 1 (Cycle length is equal to [=] 28 days)
2
Part 1: Number of Participants with Clinically Significant Abnormal Laboratory Values.
Timeframe: Cycle 1 (Cycle length is equal to [=] 28 days)
3
Part 1: Number of Participants with First Cycle Dose-Limiting Toxicities (DLTs).
Timeframe: Cycle 1 (Cycle length is equal to [=] 28 days)
4
Part 1: DLTs of Orally Administered YK-029A.
Timeframe: Cycle 1 (Cycle length is equal to [=] 28 days)
5
Part 1: Number of Participants with First Cycle Dose-Limiting Toxicities (DLTs).
Timeframe: Cycle 1 (Cycle length is equal to [=] 28 days)
6
Part 1: Maximum Tolerated Dose (MTD) of Orally Administered YK-029A
Timeframe: Cycle 1 (Cycle length is equal to [=] 28 days)
7
Part 2: Objective Response Rate (ORR) according to RECIST 1.1 by IRC
✕. Patients with NSCLC with EGFR ex20ins mutation had previously received EGFR ex20ins inhibitors and/or EGFR-cMET double antibodies (including but not limited to TAK-788, bociotinib, JNJ-61186372, DZD9008, vometinib, PLB1004, and AZD9291 in excess of the clinically approved dose (cohort 9 prohibited AZD9291 at any dose) and Drug substance or other similar drug treatment in the clinical trial stage.
✕. NSCLC patients with rare EGFR mutations have previously been treated with third-generation EGFR-Tkis (such as AZD9291, etc.) and their apis or other similar drugs in clinical trials.
✕. Received a moderate or strong CYP4503A inhibitor or moderate or strong CYP3A inducer within 10 days prior to first dose of YK-029A.
✕. Have significant, uncontrolled, or active cardiovascular disease.
✕. Have a known history of uncontrolled hypertension. Participants with hypertension should be under treatment on study entry to control blood pressure.
Part 3: Objective Response Rate (ORR) according to RECIST 1.1 by IRC