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

NCT04105010 | Completed Phase 1 Results FDA Drug

• 1 other identifier: DZ2019J0005
• Study Type: interventional
• Target: 171
• Locations: 4 countries
• Sites: 50

Brief Summary

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.

Conditions

Relapsed or Refractory Peripheral T Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Part A and Part B: Number of Participants With Adverse Events

  The first dose until 28 days after last dose, up to approximately 3 years

• Part B: Duration of Response (DoR) Assessed by IRC

  Up to approximately 3 years

• Part B: Complete Response Rate (CRR) Assessed by IRC

  Up to approximately 3 years

• Part B: Progression Free Survival (PFS) Assessed by IRC

  Up to approximately 3 years

• Part B: Time to Response (TTR) Assessed by IRC

  Up to approximately 3 years

Study Arms (4)

golidocitinib Group A

EXPERIMENTAL

Group A: Open label golidocitinib at dose A, once daily (Phase 1)

Drug: golidocitinib

golidocitinib Group B

EXPERIMENTAL

Group B: Open label golidocitinib at dose B, once daily (Phase 1)

Drug: golidocitinib

golidocitinib Group C

EXPERIMENTAL

Group C: Open label golidocitinib at a selected dose, once daily (Phase 1)

Drug: golidocitinib

golidocitinib Group D

EXPERIMENTAL

Group D: Open label golidocitinib at the RP2D, once daily (Phase 2)

Drug: golidocitinib

Interventions

golidocitinib DRUG

golidocitinib will be administered orally as capsules. golidocitinib treatment will be continued until disease progression or intolerant adverse reactions

Also known as: AZD4205

golidocitinib Group A; golidocitinib Group B; golidocitinib Group C; golidocitinib Group D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Obtained written informed consent
• 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.
• Patients must have measurable disease according to the Lugano criteria.
• 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.
• Adequate bone marrow reserve and organ system functions.

You may not qualify if:

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

Sponsors & Collaborators

• Dizal Pharmaceuticals: lead

Study Sites (50)

Yale Cancer Center

New Haven, Connecticut, 06510, United States

Location

Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Epworth Hospital

East Melbourne, Australia

Location

St Vincent's Hospital Melbourne

Fitzroy, Australia

Location

Royal Hobart Hospital

Hobart, Australia

Location

St George Hospital

Kogarah, Australia

Location

Royal Perth Hospital

Perth, Australia

Location

Westmead Hospital

Westmead, Australia

Location

Beijing Cancer Hospital

Beijing, China

Location

Beijing Friendship Hospital, Capital Medical University

Beijing, China

Location

Beijing Hospital

Beijing, China

Location

Peking University Third Hospital

Beijing, China

Location

The First Hospital of Jilin University

Changchun, China

Location

Hunan Cancer Hospital

Changsha, China

Location

Xiangya Hospital Central South University

Changsha, China

Location

Sichuan University - West China Hospital

Chengdu, China

Location

Chongqing University Cancer Hospital

Chongqing, China

Location

The Second Hospital of Dalian Medical University

Dalian, China

Location

Guangdong Provincial People's Hospital

Guangzhou, China

Location

NanFang Hospital of Southern Medical University

Guangzhou, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, China

Location

Hainan General Hospital

Haikou, China

Location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China

Location

Zhejiang Cancer Hospital

Hangzhou, China

Location

Anhui Provincial Cancer Hospital

Hefei, China

Location

The Second Hospital of Anhui Medical University

Hefei, China

Location

Shandong Cancer Hospital

Jinan, China

Location

The First Hospital of Lanzhou University

Lanzhou, China

Location

Linyi Cancer Hospital

Linyi, China

Location

Jiangxi Province Cancer Hospital

Nanchang, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, China

Location

Jiangsu Cancer Hospital

Nanjing, China

Location

Fudan University Shanghai Cancer Center

Shanghai, China

Location

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, China

Location

The First Affiliated Hospital of Xiamen University

Xiamen, China

Location

Henan Cancer Hospital

Zhengzhou, China

Location

Inje University Busan Paik Hospital

Busan, South Korea

Location

Pusan National University Hospital

Busan, South Korea

Location

Keimyung University Dongsan Hospital

Daegu, South Korea

Location

National Cancer Center

Goyang, South Korea

Location

Chonbuk National University Hospital

Jeonju, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

Samsung Medical Center

Seoul, 06133, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

• Song Y, Malpica L, Cai Q, Zhao W, Zhou K, Wu J, Zhang H, Mehta-Shah N, Ding K, Liu Y, Li Z, Zhang L, Zheng M, Jin J, Yang H, Shuang Y, Yoon DH, Gao S, Li W, Zhai Z, Zou L, Xi Y, Koh Y, Li F, Prince M, Zhou H, Lin L, Liu H, Allen P, Roncolato F, Yang Z, Kim WS, Zhu J. Golidocitinib, a selective JAK1 tyrosine-kinase inhibitor, in patients with refractory or relapsed peripheral T-cell lymphoma (JACKPOT8 Part B): a single-arm, multinational, phase 2 study. Lancet Oncol. 2024 Jan;25(1):117-125. doi: 10.1016/S1470-2045(23)00589-2. Epub 2023 Dec 9.

  PMID: 38092009 DERIVED

MeSH Terms

Conditions

Recurrence; Lymphoma, T-Cell, Peripheral

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Rika Chen
• Organization: Dizal Pharmaceuticals

clinicaltrials@dizalpharma.com

862161095875

Study Officials

• Won Seog Kim, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 26, 2019
• Study Start: September 10, 2019
• Primary Completion: October 12, 2023
• Study Completion: February 22, 2024
• Last Updated: April 4, 2025
• Results First Posted: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (6); US (4); CN (31); KR (9)