Actively Recruiting
A Phase I Study Evaluating Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TQB3122 Capsules in Advanced Malignant Tumors
Led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Updated on 2026-01-28
86
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a first-in-human clinical trial to study TQB3122, a drug designed to target advanced malignant solid tumors. The study aims to assess the safety, tolerability, and how the body processes TQB3122, while also exploring its early effects on various solid tumors including ovarian, breast, and prostate cancers. This Phase I trial is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
CONDITIONS
Brief 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...
- Participants voluntarily agree to join and sign informed consent
- Any gender, aged 18 to 75 years
- 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 tumors have failed standard treatments or lack standard options
- For Phase Ib, target lesions must meet RECIST 1.1 except for certain maintenance ovarian cancer patients; Phase Ia does not require measurable lesions
- Good major organ function
- Women of childbearing age must use contraception during and 6 months after study; men must also use contraception during and 6 months post-study
- Negative pregnancy test within 7 days before enrollment; non-lactating women
You will not qualify if you...
- History of other malignant tumors within 3 years before first study drug dose
- Unresolved toxicity or complications from prior treatments above Grade 1
- Risk of bleeding
- Arterial thrombotic events within 6 months prior to study drug
- Severe heart conditions including Grade 2 or higher myocardial ischemia, infarction, arrhythmias, congestive heart failure, or uncontrolled blood pressure
- History of psychotropic substance abuse or severe mental/neurological disorders
- Active or uncontrolled severe infections
- Active syphilis, HIV, active hepatitis B or C
- Moderate to severe lung diseases affecting breathing
- Active autoimmune diseases needing systemic treatment
- Use of prednisone over 10 mg/day or immunosuppressants within 2 weeks before dosing
- History of organ or hematopoietic stem cell transplantation
- Poorly controlled diabetes
- Leptomeningeal or central nervous system metastases
- Large effusions requiring repeated drainage or recent drainage within 2 weeks
- Current intestinal obstruction
- Allergy to study drug components
- Anti-tumor treatments within 4 weeks before study
- Use of anti-tumor Chinese patent medicines within 2 weeks before study
- Other conditions judged unsafe or unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Repeated 28-day cycles until disease progression or discontinuation.
Participants take TQB3122 Capsules once daily on an empty stomach in the morning at a fixed time, continuously in 28-day treatment cycles.
Visits occur regularly each cycle for safety and efficacy assessments
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
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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