AZD4205 in Relapsed or Refractory Peripheral T Cell Lymphoma (JACKPOT27)
- Registration Number
- NCT06511895
- Lead Sponsor
- Dizal Pharmaceuticals
- Brief Summary
This is a phase II, open label, multicenter study of AZD4205 administered orally in participants with r/r PTCL to determine its safety, tolerability, PK, and anti-tumor activity. Eligible participants are those who had pathologically confirmed PTCL and have relapsed after or been refractory/intolerant to at least one prior systemic treatment regimen. The primary objective of this study is to evaluate anti-tumor efficacy of AZD4205 at 150 mg once daily (RP2D) in participants with r/r PTCL. The safety, tolerability, and PK of AZD4205 in r/r PTCL at RP2D will also be investigated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AZD4205 treatment AZD4205 Cohort 1: Newly enrolled participants with r/r PTCL who were never exposed to AZD4205 (receive 150 mg or 75 mg). Cohort 2: Participants from other completed AZD4205 study if they are still benefiting from AZD4205 (receive 150 mg).
- Primary Outcome Measures
Name Time Method Objective response rate (ORR) assessed by investigators per Lugano criteria Up to 2 years To assess the anti-tumor efficacy of AZD4205 as a single agent in r/r PTCL.
- Secondary Outcome Measures
Name Time Method Duration of Response (DoR) Up to 2 years To further assess the anti-tumor efficacy of AZD4205 as a single agent in r/r PTCL using other efficacy endpoints.
Time to Response (TTR) Up to 2 years To further assess the anti-tumor efficacy of AZD4205 as a single agent in r/r PTCL using other efficacy endpoints.
Adverse events graded by CTCAE version 5.0 Up to 2 years To further assess the safety and tolerability of AZD4205 as a single agent in r/r PTCL.
Plasma concentration of AZD4205 Up to 2 years To characterize the pharmacokinetic of AZD4205 in plasma.
Progression-free Survival (PFS) Up to 2 years To further assess the anti-tumor efficacy of AZD4205 as a single agent in r/r PTCL using other efficacy endpoints.
Trial Locations
- Locations (19)
Hainan General Hospital
🇨🇳Haikou, Hainan, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Shandong Cancer Hospital & Insititution
🇨🇳Jinan, Shandong, China
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Anhui Provincial Hospital (The First Affiliated Hospital of USTC)
🇨🇳Hefei, Anhui, China
The Second Hospital of Anhui Meidcine University
🇨🇳Hefei, Anhui, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Chongqing Cancer Hospital
🇨🇳Chongqing, Chongqing, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Jiangsu Cancer Hospital
🇨🇳Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
The First Bethune Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Ruijing Hospital, Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Tianjin Medical University Cancer Institute & Hospital
🇨🇳Tianjin, Tianjin, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China