HH2853 for Lymphoma and Advanced Solid Tumors

This study is testing a drug called HH2853 in people with certain types of lymphoma (FL Lymphoma, Peripheral T Cell Lymphoma) and advanced solid tumors. The main goals are to find the safest and most effective dose of HH2853, and to understand any side effects. HH2853 is given as tablets twice a day. The study is open to adults aged 18 and older. It's a multi-part study, starting with finding the right dose and then expanding to learn more about how well it works and its safety. The study aims to enroll 254 participants, but its current status is unclear.

Study design
This is an open-label (meaning everyone knows what treatment is being given), multi-center, first-in-human study with three parts: dose escalation, dose extension, and Phase II. It plans to enroll 254 participants.
What's involved
You would take HH2853 tablets twice daily in continuous 28-day treatment cycles. Safety and side effects will be checked during these cycles.
Compensation
Not stated in the trial record.
Follow-up
Safety and dose-related outcomes are measured during 28-day treatment cycles.

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NCT04390737

Evaluate the Safety and Clinical Activity of HH2853

Recruiting
PHASE1Ages 18+InterventionalTreatment
Haihe Biopharma Co., Ltd.
~254 participants
Updated 2026-01-30 on ClinicalTrials.gov
What's tested:HH2853 Tablets

At a glance

Recruiting sites
21 of 25 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum tolerated Dose (MTD)
Measured over 28-day treatment cycles
+4 more outcomes measured
FL Lymphoma
Epithelioid Sarcoma
Peripheral T Cell Lymphoma
Advanced Solid Tumor
25 sites across 20 states
Beijing Municipality3
Liaoning2
Shanghai Municipality2
China2
Arizona1
Florida1
Minnesota1
Texas1
  • Fugen Li · STUDY_DIRECTOR · Haihe Biopharma Co., Ltd.

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  • Maximum tolerated Dose (MTD)28-day treatment cycles

    Determine MTD of HH2853

  • Recommended phase II dose (RP2D)28-day treatment cycles

    Determine RP2D of HH2853

  • Adverse events assessed according to NCI-CTCAE V5.028-day treatment cycles

    Evaluate the safety of HH2853

  • Dose limiting toxicities (DLT)28-day treatment cycles

    Evaluate the tolerability of HH2853

  • Objective response rate (ORR)28-day treatment cycles

    Assess the preliminary efficacy of HH2853