Actively Recruiting
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TQB3122 Capsules in Subjects With Advanced Malignant Tumors
Led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Updated on 2026-01-28
86
Participants Needed
5
Research Sites
44 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is the first-in-human clinical study of TQB3122, aiming to evaluate the safety, tolerability, and pharmacokinetic characteristics of TQB3122 in advanced solid tumors, and to preliminarily explore its efficacy in solid tumors.
CONDITIONS
Official Title
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TQB3122 Capsules in Subjects With Advanced Malignant Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agrees to participate and signs informed consent with good compliance
- Age between 18 and 75 years
- Any gender
- ECOG Performance Status score of 0 or 1 with expected survival of at least 3 months
- Histologically or cytologically confirmed advanced malignant solid tumors including ovarian, fallopian tube, primary peritoneal, breast, prostate cancers, and others
- Advanced solid tumors progressing after standard treatment or lacking standard treatment options
- For Phase Ib, target lesions meeting RECIST 1.1 criteria (except maintenance treatment for certain cancers); measurable lesions not required for Phase Ia
- Good major organ function
- Women of childbearing potential must use effective contraception during study and 6 months after; negative pregnancy test within 7 days prior to enrollment; must not be lactating
- Men must agree to use effective contraception during study and 6 months after
You will not qualify if you...
- History of other malignant tumors within 3 years before first study drug administration
- Not recovered to CTCAE Grade 1 or less from previous treatment toxicity or complications
- Risk of bleeding
- Arterial thrombotic events within 6 months before starting study drug
- Grade 2 or higher myocardial ischemia, myocardial infarction, arrhythmias, congestive heart failure, or poorly controlled blood pressure
- History of psychotropic substance abuse, epilepsy requiring treatment, or severe mental/neurological disorders
- Active or uncontrolled severe infections
- Active syphilis, HIV, or immunodeficiency diseases; active hepatitis B or C
- Moderate to severe pulmonary diseases affecting respiratory function
- Active autoimmune diseases requiring systemic treatment
- Systemic prednisone over 10 mg/day or immunosuppressive therapy within 2 weeks before administration
- History of organ transplantation (except corneal), or hematopoietic stem cell transplantation
- Poorly controlled diabetes mellitus
- Leptomeningeal metastases
- Known central nervous system involvement
- Large serous cavity effusions needing repeated drainage or recent therapeutic drainage within 2 weeks
- Current intestinal obstruction
- Known allergy to study drug components
- Anti-tumor treatments within 4 weeks before first administration
- Use of Chinese patent anti-tumor medicines within 2 weeks before first administration
- Other severe diseases or conditions judged unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100050
Not Yet Recruiting
2
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350014
Actively Recruiting
3
Meizhou People's Hospital (Meizhou Academy of Medical Sciences)
Meizhou, Guangdong, China, 514031
Not Yet Recruiting
4
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China, 200072
Not Yet Recruiting
5
Sichuan Cancer Hospital
Chengdu, Sichuan, China, 610041
Not Yet Recruiting
Research Team
Y
Yang Sun, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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