Testing TQB3122 capsules in adults with advanced solid tumors

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TQB3122 Capsules in Subjects With Advanced Malignant Tumors

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

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 86 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, prednisone
• Locations: 5 sites (Beijing, Beijing Municipality and 4 other locations)
• Trial ID: NCT07269145 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Beijing, Beijing Municipality and 4 other locations

• Beijing Friendship Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Fujian Cancer Hospital — Fuzhou, Fujian, China (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

• Study coordinator: Yang Sun, Doctor

Conditions Advanced Cancer