Study to Evaluate Efficacy and Safety of HH2853 in Relapsed/Refractory Peripheral T-cell Lymphoma

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHaihe Biopharma Co., Ltd.

About this trial

This study is a an open-label, multinational, multicenter, single-arm Phase Ⅰb/Ⅱ Study to Evaluate Efficacy and Safety of Oral HH2853 in Patients with Relapsed/Refractory Peripheral T-cell Lymphoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Tumor types and prior antitumor therapy: Phase Ib:Dose Escalation: All enrolled patients must have histologically confirmed diagnosis NHL who have received at least one line of prior systematic treatment (and ≤ 5 lines) and relapses or refractory. Phase Ib dose expansion part: All enrolled patients must have histologically confirmed diagnosis of PTCL, including subtypes: PTCL-NOS, AITL, ALK + ALCL, ALK-ALCL, NKTCL, enteropathy associated T-cell lymphoma (EATL), monomorphic epitheliotropic internal T-cell lymphoma (MEITL), Hepatosplenic T-cell lymphoma (HSTCL), follicular T-cell lymphoma (FTCL), Nodal peripheral T-cell lymphoma with TFH phenotype (Nodal PTCL-TFH) and other invasive T-cell sources NHL at the investigator and sponsor's discretion (except highly invasive). All enrolled patients had relapsed or refractory diseases after receiving 1-line systematic treatment (≤ 3 lines). Phase II: All enrolled patients must have histologically confirmed diagnosis of PTCL, including subtypes: PTCL-NOS, AITL, ALK+ALCL, ALK-ALCL, NKTCL, EATL, MEITL, HSTCL, FTCL, Nodal PTCL-TFH et al. Patients must have histologically confirmed diagnosis of R/R PTCL who have received at least one line of prior systematic combination chemotherapy and at least one new drug therapy (prior antitumor treatment lines ≤4 lines) : relapse and/or refractory.

Availability of qualified tissue samples by patient for pathological diagnosis by the central laboratory.

The Eastern cooperative oncology group (ECOG) score 0-1.

Life expectancy ≥ 3 months before starting HH2853 treatment.

Disqualifiers

Previous treatment with EZH2 or EZH1/2 inhibitors.

Central nervous system invasion.

Any previous history of bone marrow malignancy, including myelodysplastic syndrome (MDS).

Received medications that are known potent CYP3A4 inducers/inhibitors within 1 week prior to first dose.

Trial design

Design model

Single group

Treatments tested in this trial

  • HH2853 Tablets

    Drug

    25mg, 100mg and 200 mg BID oral administration

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Dose escalation and expansion study of HH2853Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Phase Ib: To determine the RP2D of HH2853 in PTCL patients

Determine RP2D of HH2853

Time frame
28-day treatment cycles
2

Phase II: To evaluate the efficacy of HH2853 of R/R PTCL patients who have received at least one prior systemic combination chemotherapy and at least one new drug

ORR will be based on the blinded independent review committee (BIRC). Assessment of oncologic response will be performed according to the 2014 edition of the Lugano Criteria for Efficacy \[Lugano\]

Time frame
28-day treatment cycles

Secondary outcomes

1

Phase Ib: 1. Preliminary efficacy of HH2853 in R/R PTCL patients;

Investigator assessed: complete response rate (CRR)

Time frame
28-day treatment cycles
2

Phase Ib: 1. Preliminary efficacy of HH2853 in R/R PTCL patients;

Duration of response (DoR)

Time frame
28-day treatment cycles
3

Phase Ib: 1. Preliminary efficacy of HH2853 in R/R PTCL patients;

Disease control rate (DCR)

Time frame
28-day treatment cycles
4

Phase Ib: 1. Preliminary efficacy of HH2853 in R/R PTCL patients;

Time to response (TTR)

Time frame
28-day treatment cycles

Other outcomes

1

Phase Ib and II: 1. To explore biomarkers related to response and effect of HH2853

mutation status of EZH2

Time frame
28-day treatment cycles
2

Phase Ib and II: 2. To explore the correlation between HH2853 exposure with safety, efficacy and pharmacokinetic parameters

Correlation between exposure (Cmax or AUC) and safety/efficacy/pharmacodynamic biomarkers (trimethylation of histone H3 at lysine 27 \[H3K27me3\])

Time frame
28-day treatment cycles

Sponsors and contacts

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