Phase 2
Completed N=171
Assessing An Oral Janus Kinase Inhibitor, AZD4205 as Monotherapy in Patients Who Have PTCL (JACKPOT8)
Source: ClinicalTrials.gov NCT04105010 ↗Enrolled (actual)
171
Serious AEs
38.6%
Results posted
Apr 2025
Primary outcomePrimary: Part B: CT-based Objective Response Rate (ORR) by Independent Review Committee (IRC) — 43.1 percentage of participants — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part B: CT-based Objective Response Rate (ORR) by Independent Review Committee (IRC) |
43.1 | <0.0001 sig |
| SECONDARY Part A and Part B: Number of Participants With Adverse Events |
26; 16; 6; 115 | — |
| SECONDARY Part B: Duration of Response (DoR) Assessed by IRC |
NA | — |
| SECONDARY Part B: Complete Response Rate (CRR) Assessed by IRC |
21.6 | — |
| SECONDARY Part B: Progression Free Survival (PFS) Assessed by IRC |
5.5 | — |
| SECONDARY Part B: Time to Response (TTR) Assessed by IRC |
1.4 | — |
| SECONDARY Part A and Part B: ORR Assessed by Investigator |
46.4; 37.5; 14.3; 38.2 | — |
| SECONDARY Part A and Part B: DoR Assessed by Investigator |
5.09; NA; 3.19; NA | — |
| SECONDARY Part A and Part B: CRR Assessed by Investigator |
28.6; 12.5; 14.3; 14.7 | — |
| SECONDARY Part A and Part B: PFS Assessed by Investigator |
3.29; 2.50; 3.32; 3.4 | — |
| SECONDARY Part B: TTR Assessed by Investigator |
1.4 | — |
| SECONDARY Part A and Part B: Maximum Plasma Concentration (Cmax) of AZD4205 |
279.8; 512.0; 258.8; 229.2 | — |
| SECONDARY Part A and Part B: Area Under the Plasma Concentration-time Curve From Zero to the Last Measurable Concentration (AUC0-t) of AZD4205 |
3592; 6755; 3276; 3271 | — |
| SECONDARY Part A and Part B: Cmax,ss, at Steady State of AZD4205 |
673.5; 1152; 665.9; 539.0 | — |
| SECONDARY Part A and Part B: AUCss, at Steady State of AZD4205 |
11978; 20991; 11822; 10000 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04105010). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.