Actively Recruiting
Phase 1/2 Clinical Study of HY07121 Powder for Solution for Infusion in Patients With Advanced Solid Tumors
Led by Sichuan Huiyu Pharmaceutical Co., Ltd · Updated on 2026-01-28
258
Participants Needed
1
Research Sites
101 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multi-center, open-label, phase 1/2 study to evaluate the safety, efficacy, and pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of HY07121 in participants with advanced solid tumors.
CONDITIONS
Official Title
Phase 1/2 Clinical Study of HY07121 Powder for Solution for Infusion in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent
- Aged 18 to 80 years, male or female
- Histologically or cytologically confirmed unresectable advanced or metastatic solid tumor that has relapsed or progressed after standard systemic treatments, refused standard treatment, or has no standard treatment available
- At least one measurable tumor lesion according to RECIST Version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of 3 months or more
- Adequate function of main organs
- Fertile female patients must have a negative pregnancy test within 7 days before first dosing and agree to use effective birth control during the study and for 6 months after last dosing
- Male patients must agree to avoid sperm donation and use effective contraception during the study and for 6 months after last dosing
- Postmenopausal women must have had no menstrual periods for at least 12 months
You will not qualify if you...
- Within washout periods required after prior anti-cancer treatments
- Participating or participated in a study with an investigational agent or device within 4 weeks before first dose
- Any other malignancy within 2 years except localized cured cancers
- Not recovered to Grade 1 or baseline from previous treatment-related adverse events
- History of active diverticulitis or symptomatic peptic ulcer disease within 2 years
- Major surgery within 4 weeks before first dose
- Symptomatic central nervous system metastases or requiring CNS therapy within 4 weeks
- Untreated or currently treated tuberculosis (except cured cases)
- Significant cardiovascular diseases or symptomatic coronary heart disease requiring treatment within 6 months
- Known HIV infection or AIDS
- Active or chronic hepatitis B or C infection, or positive treponema pallidum antibody test
- Active or suspected autoimmune disease
- History of non-infectious pneumonitis requiring steroid treatment, interstitial lung disease, or severe obstructive pulmonary disease
- History of severe allergy
- History of organ transplantation or graft-versus-host disease
- Received live/attenuated or mRNA vaccines within 4 weeks prior to screening or planned during study
- Active infection needing intravenous treatment within 4 weeks prior to first dose
- Psychiatric disorders or drug abuse interfering with trial
- Uncontrolled pleural, pericardial, or peritoneal effusions or needing drainage
- Other active malignancies within 3 years except locally cured tumors
- Considered unsuitable for participation by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Hospital of Shandong First Medical University
Jinan, China
Actively Recruiting
Research Team
J
Jinmin Yu, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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