A Study to Assess PK, Safety and Efficacy of HSK47977 Tablets in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma

ConditionNHL
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHaisco Pharmaceutical Group Co., Ltd.

About this trial

This is a Phase I Clinical Study to Evaluate the Safety, Efficacy, and PK/PD Characteristics of HSK47977 Tablets in Subjects with Relapsed or Refractory Non-Hodgkin's Lymphoma.This study includes a Phase Ia dose-escalation stage and a Phase Ib dose-expansion stage, and it is expected to take approximately 2 years.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily sign the informed consent form.

Age ≥18 years, with no gender restriction.

Pathologically confirmed patients with relapsed/refractory Non-Hodgkin Lymphoma (rrNHL).

Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.

Disqualifiers

Concurrent presence of other severe, unstable diseases/conditions that, in the investigator's judgment, make participation in this study unsuitable.

History of or current severe cardiovascular disease.

Poorly controlled blood pressure during the screening period.

Laboratory abnormalities identified by the investigator that may pose a risk to the subject's safety.

Trial design

Design model

Single group

Treatments tested in this trial

  • HSK47977

    Drug

    Taken orally once daily.

Treatment groups

110 Participants
are divided into 3 treatment groups
Group A: Phase Ia (Dose Escalation Part): HSK47977Experimental treatment 1 intervention
Group B: Phase Ia (Extension Part): HSK47977Experimental treatment 1 intervention
Group C: Phase Ib: HSK47977Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maximum tolerated dose (MTD)

Highest dose level at which under 33% of patients in a cohort experience DLT(dose limiting toxicity)

Time frame
Within first 28 days of treatment

Secondary outcomes

Other outcomes

Sponsors and contacts

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