A Multicenter, Open-Label, Phase I Dose Escalation Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of YH004 In Subjects With Advanced Solid Tumors And Relapsed Or Refractory Non-Hodgkin Lymphoma

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This is an multicenter, open-label, dose-escalation study of the study drug YH004 . The study is designed to determine the safety, tolerability, maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of YH004 in subjects with advanced solid tumors and relapsed or refractory Non-Hodgkin lymphoma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Willing and able to provide signed and dated informed consent prior to any study related procedures and willing and able to comply with all study procedures.

• Patients with histologically or cytologically confirmed advanced solid tumor or relapsed or refractory Non-Hodgkin Lymphoma (including but not limited to inert and transformed type, patients with inert lymphoma must undergo systematic treatment at the time of screening), which has progressed after treatment with standard therapies or intolerant of standard therapies or have no standard of care.

• Subject must have at least one measurable lesion by RECIST 1.1 or per Cheson criteria (Lugano 2014).

• Subjects must be 18 years to 80 years of age at the time of screening.

• Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Have life expectancy of at least 12 weeks based on investigator's judgement.

• Sufficient organ and bone marrow functions before screening or administration.

• Women of reproductive potential must have negative serum beta human chorionic gonadotropin (β -HCG) pregnancy test at the time of screening.

• Women of reproductive potential who are sexually active must consistently use highly effective contraception/birth control (less than 1% per year) between signing of the informed consent and 90 days after the last administration of the study drug.

Locations
Other Locations
China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Henan Cancer Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Fangxia Pan
fangxia.pan@eucure.com
+86 010 85950770
Time Frame
Start Date: 2023-01-31
Estimated Completion Date: 2026-02-07
Participants
Target number of participants: 38
Treatments
Experimental: Intervention/treatment
All subject will receive YH004 intravenously as single agent every three weeks (Q3W), until intolerable toxicity, disease progression, withdrawal of consent, or Investigator decision, whichever comes first.
Related Therapeutic Areas
Sponsors
Leads: Eucure (Beijing) Biopharma Co., Ltd

This content was sourced from clinicaltrials.gov