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A First-in-Human Study of HP-002 for Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

ConditionB-Cell Non-Hodgkin Lymphoma
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Helioson Pharmaceutical Co., Ltd.

About this trial

This is an open-label, first-in-human dose escalation and dose expansion Phase I/II clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of HP-002 in patients with relapsed or refractory B-Cell Non-Hodgkin Lymphoma This study consists of two phases: a dose-exploration phase and a dose-expansion phase.

The safety and tolerability of HP-002 will be evaluated in Phase 1 study, as well as the maximum tolerated dose (MTD) and the recommended dose level for Phase 2 study will be determined.

The efficacy of HP-002 will be evaluated in Phase 2 study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Eastern Cooperative Oncology Group Performance Status (ECOG) of 0-2.

Patients with relapsed or refractory B-cell non-Hodgkin lymphoma subtypes (CLL/SLL, MCL, MZL, DLBCL, FL, WM, and PCNSL).

Disqualifiers

Prior use of a BTK protein degrader.

Trial design

Design model

Parallel

Treatments tested in this trial

  • HP-002

    Drug

    HP-002 will be taken once daily, at approximately the same time each morning.

Treatment groups

114 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: escalation partExperimental treatment 1 intervention
Group B: expansion cohort 1Experimental treatment 1 intervention
Group C: expansion cohort 2Experimental treatment 1 intervention
Group D: expansion cohort 3Experimental treatment 1 intervention
Group E: expansion cohort 4Experimental treatment 1 intervention
Group F: expansion cohort 5Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose-limiting toxicities (DLTs)

Time frame
28 days after the first dose
2

Adverse events (AEs)

Time frame
up to 5 years
3

Overall Response Rate (ORR)

Time frame
up to 5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Helioson Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: