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Evaluate the Safety and Clinical Activity of HH2853

NCT04390737 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2026-01-30

No results posted yet for this study

Summary

This is an open-label, multicenter, first-in-human phase I/II study which is composed of 3 parts: phase I dose escalation, phase I dose extension and phase II. HH2853 will be administered orally on a continuous BID schedule on a continuous 28-day treatment cycle.

Conditions

  • FL Lymphoma
  • Epithelioid Sarcoma
  • Peripheral T Cell Lymphoma
  • Advanced Solid Tumor

Interventions

DRUG

HH2853 Tablets

Proposed daily dose (BID): 50mg, 100mg, 200mg, 400mg, 600mg, 800mg, 1000mg. It is possible for additional and/or intermediate dose levels to be added during the course of the study. Cohorts may be added at any dose level below the MTD in order to better understand safety, PK or PD.

Sponsors & Collaborators

  • Haihe Biopharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Fugen Li · Haihe Biopharma Co., Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-08
Primary Completion
2027-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States
  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04390737 on ClinicalTrials.gov