A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TQB3122 Capsules in Subjects With Advanced Malignant Tumors
NCT ID: NCT07269145
Last Updated: 2026-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
86 participants
INTERVENTIONAL
2026-01-22
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TQB3122 Capsules
TQB3122 Capsules: Administer once daily, recommended to be taken orally on an empty stomach in the morning at a fixed time, continuously, with each 28-day period as one treatment cycle.
TQB3122 Capsules
TQB3122 Capsules is a poly(ADP - ribose) polymerase 1 (PARP1) -targeted inhibitor.
Interventions
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TQB3122 Capsules
TQB3122 Capsules is a poly(ADP - ribose) polymerase 1 (PARP1) -targeted inhibitor.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Meizhou People's Hospital (Meizhou Academy of Medical Sciences)
Meizhou, Guangdong, China
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China
Sichuan Cancer Hospital
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TQB3122-I-01
Identifier Type: -
Identifier Source: org_study_id
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