Assessing An Oral Janus Kinase Inhibitor, AZD4205 as Monotherapy in Patients Who Have PTCL (JACKPOT8)

A Phase I/II, Open-Label, Multicentre Study to Investigate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD4205 in Patients With Peripheral T Cell Lymphoma (PTCL)

This is a multinational, non-randomized, open-label, Phase 1/2 clinical study to evaluate the safety, tolerability and anti-tumor efficacy of AZD4205 as monotherapy in patients with peripheral T cell lymphoma (PTCL), who have relapsed from or are refractory/intolerant to standard systemic treatment.

Phase 1 part:

Around 20~40 patients will be subsequently enrolled into 2 different dose ascending cohorts. Additional 10~20 patients may be enrolled to further explore a selected dose defined by dose escalation cohorts.

Phase 2 part:

After the recommended phase 2 dose (RP2D) is defined, a phase 2 single-arm open-label pivotal study will be conducted to assess anti-tumor efficacy and safety of AZD4205 at RP2D in patients with refractory or relapsed PTCL.

Study Overview

• Status: Completed
• Conditions: Relapsed or Refractory Peripheral T Cell Lymphoma
• Intervention / Treatment: Drug: golidocitinib

• Study Type: Interventional
• Enrollment (Actual): 171
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Australia
  • East Melbourne, Australia
    • Epworth Hospital
  • Fitzroy, Australia
    • St Vincent's Hospital Melbourne
  • Hobart, Australia
    • Royal Hobart Hospital
  • Kogarah, Australia
    • St George Hospital
  • Perth, Australia
    • Royal Perth Hospital
  • Westmead, Australia
    • Westmead Hospital
• China
  • Beijing, China
    • Peking University Third Hospital
  • Beijing, China
    • Beijing Cancer Hospital
  • Beijing, China
    • Beijing Friendship Hospital, Capital Medical University
  • Beijing, China
    • Beijing Hospital
  • Changchun, China
    • The First Hospital of Jilin University
  • Changsha, China
    • Xiangya Hospital Central South University
  • Changsha, China
    • Hunan Cancer Hospital
  • Chengdu, China
    • Sichuan University - West China Hospital
  • Chongqing, China
    • Chongqing University Cancer Hospital
  • Dalian, China
    • The Second Hospital of Dalian Medical University
  • Guangzhou, China
    • Guangdong Provincial People's Hospital
  • Guangzhou, China
    • Sun Yat-Sen University Cancer Center
  • Guangzhou, China
    • Nanfang Hospital of Southern Medical University
  • Haikou, China
    • Hainan General Hospital
  • Hangzhou, China
    • Zhejiang Cancer Hospital
  • Hangzhou, China
    • The first Affiliated Hospital, Zhejiang University School of Medicine
  • Hefei, China
    • The Second Hospital of Anhui Medical University
  • Hefei, China
    • Anhui Provincial Cancer Hospital
  • Jinan, China
    • Shandong Cancer Hospital
  • Lanzhou, China
    • The First Hospital of Lanzhou University
  • Linyi, China
    • LinYi Cancer Hospital
  • Nanchang, China
    • The First Affiliated Hospital of Nanchang University
  • Nanchang, China
    • Jiangxi Province Cancer Hospital
  • Nanjing, China
    • Jiangsu Cancer Hospital
  • Shanghai, China
    • Fudan University Shanghai Cancer Center
  • Shanghai, China
    • Ruijin Hospital Shanghai Jiaotong University School of Medicine
  • Suzhou, China
    • The First Affiliated Hospital of Soochow University
  • Tianjin, China
    • Tianjin Medical University Cancer Institute and Hospital
  • Wuhan, China
    • Union Hospital Tongji Medical College Huazhong University of Science and Technology
  • Xiamen, China
    • The First Affiliated Hospital of Xiamen University
  • Zhengzhou, China
    • Henan Cancer Hospital
• Korea, Republic of
  • Busan, Korea, Republic of
    • Inje University Busan Paik Hospital
  • Busan, Korea, Republic of
    • Pusan National University Hospital
  • Daegu, Korea, Republic of
    • Keimyung University Dongsan Hospital
  • Goyang, Korea, Republic of
    • National Cancer Center
  • Jeonju, Korea, Republic of
    • Chonbuk National University Hospital
  • Seongnam, Korea, Republic of
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of, 06133
    • Samsung Medical Center
• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale Cancer Center
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Winship Cancer Institute
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Obtained written informed consent
2. Patients must have histologically confirmed peripheral T-cell lymphoma according to the 2016 revision of the World Health Organization classification of lymphoid neoplasms. Tumor samples are required for central pathology review to confirm the diagnosis.
3. Patients must have measurable disease according to the Lugano criteria.
4. Patients should be transplant-ineligible upon their entry into this study, and must have relapsed after or been refractory/intolerant to ≥ 1 (but not > 3) prior systemic therapy(ies) for PTCL.
5. Adequate bone marrow reserve and organ system functions.

Exclusion Criteria:

1. Any unsolved toxicity > Common Terminology Criteria for Adverse Events (CTCAE) grade 1 from previous anti-cancer therapy (except alopecia).
2. Active infections, active or latent tuberculosis.
3. Patients with severely decreased lung function.
4. History of heart failure or QT interval prolongation.
5. Central nervous system (CNS) or leptomeningeal lymphoma.
6. History of treatment with Janus kinase (JAK) or signal transducer and activator of transcription 3 (STAT3) inhibitor.
7. Patient has undergone an allogeneic stem cell transplant. Patient had autologous stem cell transplant within 6 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: golidocitinib Group A; Group A: Open label golidocitinib at dose A, once daily (Phase 1)	Drug: golidocitinib; golidocitinib will be administered orally as capsules. golidocitinib treatment will be continued until disease progression or intolerant adverse reactions; Other Names: AZD4205
Experimental: golidocitinib Group B; Group B: Open label golidocitinib at dose B, once daily (Phase 1)	Drug: golidocitinib; golidocitinib will be administered orally as capsules. golidocitinib treatment will be continued until disease progression or intolerant adverse reactions; Other Names: AZD4205
Experimental: golidocitinib Group C; Group C: Open label golidocitinib at a selected dose, once daily (Phase 1)	Drug: golidocitinib; golidocitinib will be administered orally as capsules. golidocitinib treatment will be continued until disease progression or intolerant adverse reactions; Other Names: AZD4205
Experimental: golidocitinib Group D; Group D: Open label golidocitinib at the RP2D, once daily (Phase 2)	Drug: golidocitinib; golidocitinib will be administered orally as capsules. golidocitinib treatment will be continued until disease progression or intolerant adverse reactions; Other Names: AZD4205

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part B: CT-based Objective Response Rate (ORR) by Independent Review Committee (IRC)	ORR is the percentage of patients with at least one visit response of Complete Response (CR) or Partial Response (PR) based on CT scans evaluated by IRC per Lugano criteria.	Up to approximately 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A and Part B: Number of Participants With Adverse Events	To evaluate the safety and tolerability of AZD4205 in patients with PTCL in terms of adverse events (AEs), such as number of participants with AEs	The first dose until 28 days after last dose, up to approximately 3 years
Part B: Duration of Response (DoR) Assessed by IRC	DoR is the time from the date of first documented response until the date of documented progression or death due to any cause. Documented response and progression are both identified based on CT scans evaluated by IRC per Lugano criteria.	Up to approximately 3 years
Part B: Complete Response Rate (CRR) Assessed by IRC	CRR is the percentage of patients with at least one visit response of CR based on CT scans evaluated by IRC per Lugano criteria.	Up to approximately 3 years
Part B: Progression Free Survival (PFS) Assessed by IRC	PFS is the time from the date of first dosing until the date of objective disease progression or death (by any cause) regardless of whether the participant discontinues the study treatments. Progression is identified based on CT scans evaluated by IRC per Lugano criteria.	Up to approximately 3 years
Part B: Time to Response (TTR) Assessed by IRC	TTR is the time from the date of first dosing to the time of the initial response of PR or CR. Response is identified based on CT scans evaluated by IRC per Lugano criteria.	Up to approximately 3 years
Part A and Part B: ORR Assessed by Investigator	ORR is the percentage of patients with at least one visit response of CR or PR based on CT and/or PET scans evaluated by investigator per Lugano criteria.	Up to approximately 3 years
Part A and Part B: DoR Assessed by Investigator	DoR is the time from the date of first documented response until the date of documented progression or death due to any cause. Documented response and progression are both identified based on CT and/or PET scans evaluated by investigator per Lugano criteria.	Up to approximately 3 years
Part A and Part B: CRR Assessed by Investigator	CRR is the percentage of patients with at least one visit response of CR based on CT and/or PET scans evaluated by investigator per Lugano criteria.	Up to approximately 3 years
Part A and Part B: PFS Assessed by Investigator	PFS is the time from the date of first dosing until the date of objective disease progression or death (by any cause) regardless of whether the participant discontinues the study treatments. Progression is identified based on CT and/or PET scans evaluated by investigator per Lugano criteria.	Up to approximately 3 years
Part B: TTR Assessed by Investigator	TTR is the time from the date of first dosing to the time of the initial response of PR or CR. Response is identified based on CT scans evaluated by investigator per Lugano criteria.	Up to approximately 3 years
Part A and Part B: Maximum Plasma Concentration (Cmax) of AZD4205	Maximum observed plasma concentration, obtained directly from the observed concentration versus time data. Calculated for the single dose.	Cycle 1 Day 1 (each cycle = 21 days): 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, and 24 hours postdose (for Group A, B and C); 0 (predose), 1, 2, 4, 6, 8, and 24 hours postdose (for Group D).
Part A and Part B: Area Under the Plasma Concentration-time Curve From Zero to the Last Measurable Concentration (AUC0-t) of AZD4205	Area under the plasma concentration-time curve from time zero to the last quantifiable time point, calculated by the linear up/log down rule.	Cycle 1, Day 1 (each cycle = 21 days): 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, and 24 hours postdose (for Group A, B and C); 0 (predose), 1, 2, 4, 6, 8, and 24 hours postdose (for Group D).
Part A and Part B: Cmax,ss, at Steady State of AZD4205	Maximum observed plasma concentration (ng/mL) at steady state, obtained directly from the observed concentration versus time data. Calculated for the multiple doses.	Cycle 2 Day 1 (each cycle = 21 days): 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, and 24 hours postdose (for Group A, B and C); 0 (predose), 1, 2, 4, 6, 8, and 24 hours postdose (for Group D).
Part A and Part B: AUCss, at Steady State of AZD4205	Area under the plasma concentration-time curve from time zero to the last quantifiable time point at steady state, calculated by the linear up/log down rule	Cycle 2 Day 1 (each cycle = 21 days): 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, and 24 hours postdose (for Group A, B and C); 0 (predose), 1, 2, 4, 6, 8, and 24 hours postdose (for Group D).

Collaborators and Investigators

• Sponsor: Dizal Pharmaceuticals
• Investigators: Principal Investigator: Won Seog Kim, PhD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2019
• Primary Completion (Actual): October 12, 2023
• Study Completion (Actual): February 22, 2024

Study Registration Dates

• First Submitted: September 18, 2019
• First Submitted That Met QC Criteria: September 24, 2019
• First Posted (Actual): September 26, 2019

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
• Other Study ID Numbers: DZ2019J0005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No