Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 to 75

Testing TQB3122 capsules in adults with advanced solid tumors

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

Run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · NCT07269145 · Data updated 2026-11-12

This trial will try TQB3122 capsules in adults with advanced solid tumors who have exhausted standard treatments to check safety, how the body handles the drug, and any early signs it might work.

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment86 (estimated)
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.
Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy, prednisone
Locations5 sites (Beijing, Beijing Municipality and 4 other locations)
StatusRecruiting
StartedJanuary 22, 2026
Main results expectedDecember 2026
Study endsDecember 2026
Registry record updatedJanuary 28, 2026
Trial IDNCT07269145 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18–75 with histologically or cytologically confirmed advanced solid tumors who have failed or lack standard treatment options and have ECOG 0–1 are the intended candidates.

Probably not a fit

Patients with poor performance status (ECOG >1), life expectancy under three months, or significant uncontrolled medical conditions are unlikely to benefit or be eligible for this trial.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human, Phase I, multi-center study of oral TQB3122 in adults with advanced malignant solid tumors. The study uses dose-escalation followed by dose-expansion stages to define safety, tolerability, and pharmacokinetics and to look for preliminary signs of anti-tumor activity. Eligible patients generally have histologically or cytologically confirmed advanced solid tumors that progressed on or are not amenable to standard therapy and have ECOG performance status 0–1. The trial is being conducted at several sites in China and will enroll participants to characterize adverse events, drug exposure, and tumor response by RECIST where applicable.

Why it matters

Potential benefit: If successful, TQB3122 could provide a new treatment option that stabilizes disease or slows tumor growth for some patients with advanced solid tumors.

How similar studies have gone: This is a first-in-human trial, and while some early-phase targeted therapy studies have shown promising signals, TQB3122 itself has not yet been tested in humans.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* The subject voluntarily participates in this study, signs the informed consent form, and has good compliance;
* Gender is not restricted; age (calculated as of the date of signing the informed consent form): 18-75 years old;
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0-1; expected survival period ≥ 3 months;
* Patients with histologically or cytologically confirmed advanced malignant solid tumors, including but not limited to epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, breast cancer, prostate cancer, etc.;
* Advanced solid tumors that have failed standard treatment (disease progression or intolerance) or for which there is no standard treatment plan;
* For Phase Ib (dose expansion stage), except for patients receiving maintenance treatment for ovarian cancer/fallopian tube cancer/primary peritoneal cancer, other patients are required to have target lesions meeting the RECIST 1.1 criteria. For Phase Ia (dose escalation stage), measurable lesions are not required;
* Good function of major organs;
* Women of childbearing age must agree to use effective contraceptive measures during the study and within 6 months after the end of the study; serum or urine pregnancy test must be negative within 7 days before enrollment, and they must be non-lactating subjects; men must agree to use effective contraceptive measures during the study and within 6 months after the end of the study.

Exclusion Criteria:

* History of other malignant tumors within 3 years prior to the first administration of the study drug;
* Failure to recover from toxicity and/or complications of previous interventions to CTCAE ≤ Grade 1;
* Risk of bleeding;
* Arterial thrombotic events occurring within 6 months prior to the first administration;
* Suffering from ≥ Grade 2 myocardial ischemia or myocardial infarction, supraventricular or ventricular arrhythmias, and ≥ Grade 2 congestive heart failure; poorly controlled blood pressure;
* History of psychotropic substance abuse with inability to abstain, or presence of mental disorders; patients with epilepsy requiring treatment; or patients with severe mental or neurological diseases;
* Active or uncontrolled severe infections;
* Active syphilis; HIV infection or other immunodeficiency diseases; active hepatitis B or active hepatitis C;
* Complicated with moderate to severe pulmonary diseases that significantly affect respiratory function;
* Patients with active autoimmune diseases requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants);
* Receipt of systemic treatment with prednisone \> 10 mg/day or equivalent drugs, or any other form of immunosuppressive therapy within 2 weeks prior to administration;
* History of organ transplantation (except corneal transplantation), allogeneic or autologous hematopoietic stem cell transplantation;
* Poorly controlled diabetes mellitus;
* Patients with leptomeningeal (including arachnoid and pia mater) metastases;
* Known central nervous system (CNS) involvement;
* Presence of massive serous cavity (pleural, peritoneal, or pericardial) effusions requiring repeated drainage to relieve clinical symptoms, or receipt of therapeutic serous cavity effusion drainage within 2 weeks prior to treatment;
* Current intestinal obstruction;
* Known allergy to the components of the study drug;
* Receipt of anti-tumor treatments such as radiotherapy, chemotherapy, targeted therapy, or immunotherapy within 4 weeks prior to the first administration;
* Receipt of Chinese patent medicines explicitly indicated for anti-tumor use in their drug labels approved by National Medical Products Administration (NMPA) within 2 weeks prior to the first administration;
* According to the investigator's judgment, subjects with concomitant diseases that severely endanger their safety or affect the completion of the study, or those deemed unsuitable for enrollment for other reasons.

Where it's running

  • Fujian Cancer Hospital
    Fuzhou, Fujian, China
    Recruiting
  • Beijing Friendship Hospital, Capital Medical University
    Beijing, Beijing Municipality, China
    Not yet recruiting
  • Meizhou People's Hospital (Meizhou Academy of Medical Sciences)
    Meizhou, Guangdong, China
    Not yet recruiting
  • Shanghai Tenth People's Hospital
    Shanghai, Shanghai Municipality, China
    Not yet recruiting
  • Sichuan Cancer Hospital
    Chengdu, Sichuan, China
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.