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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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• Expected survival \>3 months.

• Presence of measurable lesions.

• Adequate organ function.

• Agreement to undergo pathological tissue biopsy.

• Subjects of childbearing potential must agree to comply with the contraceptive requirements of the study.

⁃ No pregnancy plans from screening until at least 3 months after the last dose of the study drug, and voluntary use of effective contraceptive measures.

Locations
Other Locations
China
Chinese Academy of Medical Sciences Blood Diseases Hospital
RECRUITING
Tianjin
Contact Information
Primary
Yunfen Li
liyunfen@haisco.com
(+86)18108214952
Time Frame
Start Date: 2025-08-28
Estimated Completion Date: 2027-12
Participants
Target number of participants: 110
Treatments
Experimental: Phase Ia (Dose Escalation Part): HSK47977
Phase 1a (Dose Escalation Part): dose escalation of HSK47977 at various dose levels
Experimental: Phase Ia (Extension Part): HSK47977
Phase 1a (Part B): dose extention of HSK47977 at certain dose levels
Experimental: Phase Ib: HSK47977
Phase 1b: dose expansion for HSK47977 at dose of RP2D(Recommended Phase II Dose)
Related Therapeutic Areas
Sponsors
Leads: Haisco Pharmaceutical Group Co., Ltd.

This content was sourced from clinicaltrials.gov