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

Dizal Pharma

Status and phase: Completed; Phase 2; Phase 1

Conditions: Relapsed or Refractory Peripheral T Cell Lymphoma

Treatments: Drug: golidocitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT04105010

DZ2019J0005

Details and patient eligibility

About

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.

Enrollment: 171 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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171 participants in 4 patient groups

golidocitinib Group A

Experimental group

Description:

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

Treatment:

Drug: golidocitinib

golidocitinib Group B

Experimental group

Description:

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

Treatment:

Drug: golidocitinib

golidocitinib Group C

Experimental group

Description:

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

Treatment:

Drug: golidocitinib

golidocitinib Group D

Experimental group

Description:

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

Treatment:

Drug: golidocitinib