What is TQB3122 studying for advanced cancer?

TQB3122 is being studied as a potential treatment for advanced malignant tumors by evaluating its safety, tolerability, and how it behaves in the body. The study also explores its early effects on various solid tumors. This research is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Who may be eligible for this advanced cancer clinical trial?

Adults aged 18 to 75 years with confirmed advanced malignant solid tumors may be eligible regardless of gender. Participants need a good performance status and must have failed standard treatments or have no standard options. Please review eligibility criteria for more details.

Is there any cost to participate in this advanced cancer clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 1

Age: 18Years - 75Years

All Genders

ID07269145

Phase I Study of TQB3122 Capsules to Assess Safety, Tolerability, and Early Effects in Adults With Advanced Solid Tumors

Led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Updated on 2026-01-28

Participants Needed

Research Sites

N/A

Total Duration

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

Age: 18Years - 75Years

All Genders

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

Research Team

Yang Sun, Doctor

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Phase I Study of TQB3122 Capsules to Assess Safety, Tolerability, and Early Effects in Adults With Advanced Solid Tumors

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria