A Study of WJ05129 in Advanced Malignant Solid Tumors (NCT05326035) | Clinical Trial Compass
TerminatedPhase 1/2
A Study of WJ05129 in Advanced Malignant Solid Tumors
Stopped: The sponsor terminated the study on the basis of the current data and the company's research and development strategy
China26 participantsStarted 2022-04-19
Plain-language summary
This study was an open, multicenter Phase I/II clinical study of WJ05129 in patients with locally advanced or metastatic malignant solid tumors in China, which was divided into three stages: Single-dose escalation,Combined dose extension and efficacy extension. The study included screening, treatment and follow-up periods. The starting dose of this dose-escalation study was set at 2.5 mg/day. Five dose levels were preset.A more flexible "BOIN" dose escalation method was adopted. The maximum tolerated dose observation period was the first treatment cycle of single administration and multiple consecutive administrations (a total of 2 days) + 21 days = 23 days; In this stage, the two dosage levels of the injectable WJ05129 (RP2D dosage and the lower dose before RP2D) will be selected as the escalating doses for the combined use of WJ05129. The "BOIN" design will be adopted for dose escalation. Paclitaxel 80mg/m2 will be intravenously infused on days 1, 8, and 15. A 28-day cycle will be used, with the first cycle being the DLT observation period.Efficacy expansion phase: It is preliminarily planned to expand three cohorts of Rb negative TNBC and SCLC andOther solid tumors（Such as gastric and esophageal adenomas, gynecological tumors, etc.）, and recruit about 20-40 people in each cohort.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Willing to participate in the clinical trial of this drug, able to understand and sign informed consent, willing and able to comply with the planned visit and study procedures;
✓. Age ≥18 to 75 years old, male and female;
✓. Locally advanced (except for patients who can be treated with radical therapy) or metastatic malignant solid tumors confirmed by histology or cytology;
✓. The single-dose escalation phase requires patients who have failed standard treatment, are intolerant to standard treatment, or have no standard treatment options；The combined dose escalation phase and the efficacy expansion phase require no treatment with taxane drugs for metastatic diseases, with no more than 4 lines of treatment, and meet one of the following conditions:
✓. SCLC: After receiving a platinum-based standard chemotherapy regimen for first-line treatment, whether in localized stage (LS) or extensive stage (ES), there has been progression;
✓. TNBC: After receiving first-line standard treatment, previous adjuvant taxane treatment is allowed, provided that the disease-free interval from (new) adjuvant chemotherapy to the development of metastatic disease is ≥ 1 year;
✓. Other solid tumors: After receiving the first-line standard treatment recommended by CSCO or NCCN guidelines;
What they're measuring
1
DLT
Timeframe: 2 years
2
The incidence of adverse events (AE) and serious adverse events (SAE) were assessed
. Eastern Cooperative Oncology Group (ECOG) Physical status score (Annex 2) 0 to 1;
Exclusion criteria
✕. Persons already known to be allergic to the active ingredients or excipients of the study drugs (WJ05129 tablets) ；
✕. Patients previously treated with AURORA A kinase inhibitors (Alisertib, LY3295668, etc.) ；
✕. Subjects who received a potent cytochrome CYP3A inhibitor or inducer within 14 days prior to initial administration and who needed to take these drugs throughout the study period;
✕. Participate in other clinical studies within 4 weeks prior to initial administration, except during the follow-up period of observational (non-interventional) clinical studies or interventional studies;
✕. Inability to swallow drugs orally, or having a condition that seriously affects gastrointestinal absorption as judged by the investigator;
✕. Pregnant or lactating women;
✕. Two or more malignancies within 5 years prior to first administration. Except for early stage malignant neoplasms (carcinoma in situ or stage I neoplasms) that have been eradicated, such as adequately treated carcinoma in situ of the cervix, basal cell or squamous cell carcinoma, etc.;
✕. Underwent major surgery (as determined by the investigator) or was undergoing surgical recovery within 4 weeks prior to initial dosing. Anti-tumor chemotherapy (eluting for 6 weeks for the last chemotherapy with nitrosourea or mitomycin), radiotherapy, targeted therapy, hormone therapy, immunotherapy, or biotherapy within 4 weeks prior to initial administration. Receive anti-tumor or immunomodulatory TCM or Chinese adult medicine preparations within 2 weeks before the first administration;