AZD4205 in Relapsed or Refractory Peripheral T Cell Lymphoma (JACKPOT27)

NCT06511895 | Completed Phase 2

• 1 other identifier: DZ2021J0006
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 19

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.

Conditions

Peripheral T Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Duration of Response (DoR)

  Up to 2 years

• Time to Response (TTR)

  Up to 2 years

• Progression-free Survival (PFS)

  Up to 2 years

• Adverse events graded by CTCAE version 5.0

  Up to 2 years

• Plasma concentration of AZD4205

  Up to 2 years

Study Arms (1)

AZD4205 treatment

EXPERIMENTAL

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).

Drug: AZD4205

Interventions

AZD4205 DRUG

AZD4205 capsules administered at 150 mg or 75 mg orally, once daily, in 28-day cycle.

AZD4205 treatment

Eligibility Criteria

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

You may qualify if:

• ≥ 18 years old (for Korean ≥ 19 years old)
• ECOG performance status 0-2 with no deterioration over the previous 2 weeks
• Predicted life expectancy ≥ 12 weeks.
• Histologically confirmed PTCL by local pathology review according to the 2016 revision of the WHO classification of lymphoid neoplasms. Eligible histological subtypes are restricted to the following:
• PTCL-NOS
• AITL
• ALCL ALK+
• ALCL ALK-
• EATL
• MEITL
• NKTCL
• HSTCL
• SPTCL
• Have measurable disease according to the 2014 Lugano classification
• Must have progressed on or are refractory to standard systemic therapy, or patients were intolerant to standard systemic therapy. Participants should be transplant-ineligible upon their entries to this study.

You may not qualify if:

• Intervention with any of the following:
• Any investigational agents or study drugs from a previous clinical study within 30 days of the first dose of study treatment.
• Any cytotoxic chemotherapy from a previous treatment regimen within 21 days of the first dose of study treatment.
• Prior HDAC inhibitors (including romidepsin, belinostat and chidamide) or pralatrexate therapy within one week of the start of the study treatment.
• Corticosteroids at dosages equivalent to prednisone \> 15 mg/day within 7 days of the start of the study treatment.
• Major surgery procedure (excluding placement of vascular access), or significant traumatic injury within 4 weeks of the first dose of study treatment, or have an anticipated need for major surgery during the study.
• Prior therapeutic anticancer antibodies (including brentuximab vedotin) within 4 weeks, other radio- or toxin-immunoconjugates within 10 weeks, radiation therapy within 3 weeks.
• Has undergone an allogeneic stem cell transplant. Participant had autologous stem cell transplant within 6 months.
• Prior treatment with a JAK or STAT3 inhibitor.
• Prior treatment with any onco-immunotherapy in 28 days prior to first dosing of AZD4205.
• Live vaccines within 28 days prior to first dose.
• Currently receiving (or unable to stop use at least 1 week prior to receiving the first dose) vitamin K antagonists, anti-platelet agents or anticoagulated agents.
• Currently receiving (or unable to stop use at least 1 week prior to receiving the first dose) medications or herbal supplements known to be potent inhibitors or inducers of CYP3A or sensitive substrates of BCRP or P-gp with narrow therapeutic index.
• Any unresolved toxicities from prior therapy, greater than CTCAE v 5.0 Grade 1 at the time of starting study treatment with the exception of alopecia.
• Central nervous system or leptomeningeal lymphoma.

Sponsors & Collaborators

• Dizal Pharmaceuticals: lead

Study Sites (19)

Anhui Provincial Hospital (The First Affiliated Hospital of USTC)

Hefei, Anhui, China

Location

The Second Hospital of Anhui Meidcine University

Hefei, Anhui, China

Location

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, China

Location

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China

Location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Location

Hainan General Hospital

Haikou, Hainan, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

Hunan Cancer Hospital

Changsha, Hunan, China

Location

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Location

The First Bethune Hospital of Jilin University

Changchun, Jilin, China

Location

Shandong Cancer Hospital & Insititution

Jinan, Shandong, China

Location

Ruijing Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Condition Hierarchy (Ancestors)

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

Study Officials

• Yuqin Song

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 22, 2024
• Study Start: May 31, 2022
• Primary Completion: October 17, 2025
• Study Completion: October 17, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (19)