רדאר קליני AI | ||
|---|---|---|
הניסוי הקליני NCT07107490 עבור סרטן ריאות תאים קטנים בשלב מתקדם הוא מגייס. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן. | ||
מחקר אחד תואם לקריטריוני המסנן
תצוגת כרטיסים
חזרה לחיפוש
צ'וגאי פרמצבטיקהA PHASE I STUDY OF ALPS12 IN PATIENTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER שלב I 122 תווית פתוחה
פרטי הניסויים הקליניים זמינים בעיקר באנגלית. רדאר קליני AI יכול לעזור! לחץ על 'הסבר את המחקר' כדי לצפות ולשוחח על מידע מהמחקר בשפה המועדפת עליך.
ניסוי קליני NCT07107490 מתקיים כדי לבדוק את טיפול עבור סרטן ריאות תאים קטנים בשלב מתקדם. זהו מחקר שלב I מסוג התערבותי שנמצא כעת במצב מגייס. המחקר התחיל ב-8 באוקטובר 2025 ומתוכנן לכלול 122 משתתפים. המחקר מנוהל על ידי צ'וגאי פרמצבטיקה וצפוי להסתיים ב-30 בספטמבר 2028. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-6 בפברואר 2026.
סיכום קצר
This study is a phase I, open-label, multicenter trial designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of ALPS12 in patients with extensive-stage small cell lung cancer. The study consists of two parts: a dose-escalation part and an expansion part.
כותרת רשמית
AN OPEN-LABEL, MULTICENTER PHASE I STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND PRELIMINARY ANTI-TUMOR ACTIVITY OF ALPS12 IN PATIENTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER
מצבים רפואיים
סרטן ריאות תאים קטנים בשלב מתקדםמזהי מחקר נוספים
- ALP102CT
מספר NCT
תחילת המחקר (בפועל)
2025-10-08
עדכון אחרון שפורסם
2026-02-06
סיום המחקר (מוערך)
2028-09-30
משתתפים (מתוכנן)
122
סוג המחקר
התערבותי
שלב
שלב I
סטטוס
מגייס
מטרה ראשית
טיפול
הקצאת טיפול
לא אקראי
דגם מתערב
שיוך רצף
עיוורון
אין (מחקר פתוח)
זרועות / התערבויות
| קבוצת משתתפים/זרוע | התערבות/טיפול |
|---|---|
ניסיDose escalation part Patients will receive ALPS12 as a single agent following pretreatment of obinutuzumab to determine the MTD by evaluating DLTs in patients with extensive stage small cell lung cancer. | ALPS12 ALPS12 as an IV infusion obinutuzumab Obinutuzumab as an IV infusion |
ניסיExpansion part Patients will receive ALPS12 as a single agent following pretreatment of obinutuzumab to evaluate the antitumor effect. | ALPS12 ALPS12 as an IV infusion obinutuzumab Obinutuzumab as an IV infusion |
מדדי תוצאה ראשיים
מדדי תוצאה משניים
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
All part : Adverse events of ALPS12[safety and tolerability] | Incidence, nature, and severity of AEs graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v.5.0, and CRS and Immune effector cell-associated neurotoxicity syndrome (ICANS) graded according to the ASTCT Consensus Grading Criteria | From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months) |
Dose Escalation part : Dose-limiting toxicities (DLTs) and PK profile of ALPS12[safety and tolerability] | Nature and frequency of DLTs, AEs, PK and PD profiles | From Cycle 1 Day 1 to the administration of ALPS12 on Cycle 2 Day 1 (Cycle 1 is 21 days) |
Dose Escalation part : Immunogenicity of ALPS12 | Incidence of ADAs to ALPS12 and potential correlation with PK parameters and safety | From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months) |
Expansion part : Preliminary anti-tumor activity of ALPS12 when administered at selected dose(s) based on tumor assessment in patients with extensive stage SCLC | Objective response, defined as a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1, as determined by the Investigators | From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months) |
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
Objective response rate(ORR)[preliminary efficacy] | ORR assessed per RECIST v.1.1 by the investigators. | From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months) |
Disease control [preliminary efficacy] | defined as the proportion of patients who have CR, PR, or stable disease (SD) as best overall response per RECIST v.1.1 as determined by the investigator. | From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months) |
Duration of response (DoR)[preliminary efficacy] | Duration of response (DoR), defined as the time from the first occurrence of CR or PR to progression disease (PD) or death from any cause (whichever occurs first), per the investigator according to RECIST v.1.1 | From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months) |
Progression-free survival (PFS)[preliminary efficacy] | Progression-free survival (PFS), defined as the time from administration of first study treatment to the first occurrence of disease progression or death from any cause, as determined by the investigator according to RECIST v.1.1 | From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months) |
Overall survival (OS)[preliminary efficacy] | Overall survival (OS), defined as the time from administration of first study treatment to death from any cause | From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months) |
Immunogenicity of obinutuzumab | Incidence of ADAs to obinutuzumab and potential correlation with PK parameters and safety | From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months) |
Maximum serum concentration (Cmax) and Area under the concentration time-curve (AUC) of ALPS12 with obinutuzumab[PK profile] | Serum ALPS12 concentration and its PK parameters including Cmax and AUC etc. | From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months) |
Adverse events of obinutuzumab[safety and tolerability] | Incidence, nature, and severity of adverse events graded according to NCI Common Terminology CTCAE v5.0, with severity of CRS determined according to the American Society for Transplantation and Cell Therapy (ASTCT) Consensus Grading Criteria(In parts with obinutuzumab premedication) | From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months) |
עוזר השתתפות
קריטריוני זכאות
גילאים מוערכים למחקר
מבוגר, גיל שלישי
גיל מינימלי למחקר
18 Years
מגדרים מוערכים למחקר
הכל
- Aged >18 years at time of informed consent
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
- Histologically documented extensive stage small cell lung cancer
- Disease recurrence documented after at least one prior systemic therapy.
- Confirmed availability of representative archival tumor specimens or fresh tumor specimen.
- Measurable disease per RECIST v.1.1.
- Adequate hematologic and end organ function
- Pregnant or breastfeeding, or intending to become pregnant or breastfeeding during the study
- History or complication of clinically significant autoimmune disease
- a positive HIV antibody test at screening
- Active hepatitis B or hepatitis C
- Prior treatment with anti-CD137 antibody drugs, anti-CD3 antibody drugs, and/or DLL3-targeted therapies
- Patients who have received any investigational or approved anticancer therapy, including hormone therapy and/or radiotherapy, within 21 days prior to the first administration of the investigational drug.
- History of Grade 4 immune-related adverse events caused by prior anti-PD-L1/PD-1 antibody drugs or anti-CTLA-4 antibody drugs (excluding asymptomatic elevations in serum amylase/lipase)
- Patients who discontinued immunotherapy due to Grade 3 immune-related adverse events caused by prior anti-PD-L1/PD-1 antibody drugs or anti-CTLA-4 antibody drugs (excluding asymptomatic elevations in serum amylase/lipase), and/or patients who experienced Grade 3 immune-related adverse events caused by immunotherapy within 6 months prior to the first administration of the investigational drug
- Patients who received a live attenuated vaccine within 4 weeks prior to the first administration of the investigational drug
- History or clinical evidence of primary central nervous system (CNS) malignancy, symptomatic CNS metastases, CNS metastases requiring any anti tumor treatment, or leptomeningeal disease
- Current or past CNS diseases (e.g., stroke, epilepsy, CNS vasculitis, neurodegenerative diseases)
צ'וגאי פרמצבטיקהאיש קשר מרכזי למחקר
איש קשר: Clinical trials information, only use Email, [email protected]
6 מיקומי המחקר ב-3 מדינות
Queen Mary Hospital, Hong Kong, Hong Kong
מגייס
Chiba
National Cancer Center Hospital East, Kashiwa, Chiba, 277-8577, Japan
מגייס
Ehime
Ehime University Hospital, Tōon, Ehime, 791-0295, Japan
מגייס
Osaka
Kindai University Hospital, Sakai, Osaka, 590-0197, Japan
מגייס
Niigata Cancer Center Hospital, Niigata, 951-8566, Japan
מגייס
Show Chwan Memorial Hospital, Changhua, 500, Taiwan
מגייס