AZD4205 in Relapsed or Refractory Peripheral T Cell Lymphoma (JACKPOT27)
NCT Number: NCT06511895
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Peripheral T Cell Lymphoma
Interventions: DRUG: AZD4205
Sponsor: Dizal Pharmaceuticals
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-05-31
Completion Date: 2026-12
Locations: 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|Peking University Third Hospital, Beijing, Beijing, China|Chongqing Cancer Hospital, Chongqing, Chongqing, China|Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China|Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China|Hainan General Hospital, Haikou, Hainan, China|Henan Cancer Hospital, Zhengzhou, Henan, China|Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, Hubei, 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|Shandong Cancer Hospital & Insititution, Jinan, Shandong, China|Ruijing Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai, China|West China Hospital of Sichuan University, Chengdu, Sichuan, China|Tianjin Medical University Cancer Institute & Hospital, Tianjin, Tianjin, China|Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China

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.

Primary Outcome Measures: Objective response rate (ORR) assessed by investigators per Lugano criteria, To assess the anti-tumor efficacy of AZD4205 as a single agent in r/r PTCL., Up to 2 years
Secondary Outcome Measures: Duration of Response (DoR), To further assess the anti-tumor efficacy of AZD4205 as a single agent in r/r PTCL using other efficacy endpoints., Up to 2 years|Time to Response (TTR), To further assess the anti-tumor efficacy of AZD4205 as a single agent in r/r PTCL using other efficacy endpoints., Up to 2 years|Progression-free Survival (PFS), To further assess the anti-tumor efficacy of AZD4205 as a single agent in r/r PTCL using other efficacy endpoints., Up to 2 years|Adverse events graded by CTCAE version 5.0, To further assess the safety and tolerability of AZD4205 as a single agent in r/r PTCL., Up to 2 years|Plasma concentration of AZD4205, To characterize the pharmacokinetic of AZD4205 in plasma., Up to 2 years