Clinical trial NCT06798207: A Clinical Trial of TQB2102 for Injection in Gynecological Tumors With Recurrent/Metastatic Advanced
Official title: A Phase 2 Clinical Trial of TQB2102 for Injection in the Treatment of Patients With Recurrent/Metastatic Advanced Gynecological Tumors to Evaluate the Safety and Efficacy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Gynecological Tumors
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-01-29
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: TQB2102 is an antibody-drug conjugate comprised of a humanised antibody against Human Epidermal Growth Factor Receptor 2 (HER2), a enzyme-cleavable linker, and a topoisomerase I inhibitor payload, which combine the ability of antibodies to specifically target tumour cells with the highly potent killing activity of drugs with payloads too toxic for systemic administration. This is a Phase 2 study to evaluate the efficacy,and safety of TQB2102 for injection in recurrent/metastatic advanced gynecological tumors.


Eligibility criteria: Inclusion Criteria:

* Subjects voluntarily participate in this study, sign informed consent and have good compliance.
* The age is ≥ 18 years old (subject to the date of signing the informed consent); Female ; eastern cooperative oncology group (ECOG ) score 0-1 ; estimated survival time ≥ 3 months ;
* Histologically confirmed, unresectable recurrent / metastatic advanced gynecologic tumors;
* The HER2 expression status (IHC 3+, 2+, 1+ or 0) is confirmed in the tumor tissue, and the subjects with completely negative IHC 0 staining are excluded.
* Previous chemotherapy with platinum-based drugs was unsuccessful.
* There is at least one measurable lesion according to the RECIST 1.1 criteria; women of childbearing potential need to meet the following conditions: the serum/urine pregnancy test result is negative before the first administration; they agree to adopt highly effective contraceptive measures (with an annual failure rate of less than 1%) throughout the study period. Women of childbearing potential are defined as premenopausal women who have not had a record of tubal ligation or hysterectomy, or women who have been postmenopausal for no more than 1 year.

Exclusion Criteria:

* Other malignant tumors occurred within the past 5 years before treatment or currently suffered simultaneously.
* Uncontrollable toxic reactions above CTCAE Grade 1 caused by any previous treatment, excluding alopecia.
* Received major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days before the start of treatment.
* Long-term unhealed wounds or fractures.
* Subjects with a history of interstitial lung disease/pneumonia ( non-infectious type ) that required steroid drug intervention treatment in the past, or currently accompanied by interstitial lung disease/pneumonia, or those with suspected interstitial lung disease/pneumonia indicated by screening imaging and cannot be excluded.
* Subjects with moderate to severe pulmonary dysfunction/disease within 3 months before the first administration.
* Arterial/deep vein thrombosis events occurred within 6 months before treatment, such as cerebrovascular accidents, deep vein thrombosis, and pulmonary embolism.
* Subjects with any severe and/or uncontrolled diseases.
* Patients with local recurrence suitable for surgery or radiotherapy.
* Those with disease progression after receiving chemotherapy drugs of topoisomerase I inhibitors or ADC drugs with small molecule toxins as topoisomerase I inhibitors in the previous first-line treatment.
* Any anti-cancer therapy or any other experimental drug treatment within 28 days or 5 half-lives before the first administration in this study.
* Received treatment with Chinese patent medicines with clear anti-tumor indications in the drug instructions approved by National Medical Products Administration (NMPA) within 2 weeks before the first administration in this study.
* Serosal effusion that requires repeated drainage to relieve clinical symptoms, or those who received serosal effusion drainage for treatment purposes within 2 weeks before treatment.
* Patients with clinically significant tumor bleeding or perforation within 1 month before the start of the study treatment, or any bleeding event ≥ CTCAE Grade 3, or patients with bleeding or coagulation disorders who are using warfarin, aspirin, or other antiplatelet aggregation drugs.
* Subjects with known central nervous system metastasis and/or carcinomatous meningitis, with diffuse dissemination. Subjects with a history of brain metastasis may be considered for inclusion if clinically stable.
* Severe bone damage and spinal cord compression caused by tumor bone metastasis, including weight-bearing bone pathological fractures that occurred within 6 months or are likely to occur in the near future, poorly controlled severe bone pain, etc.
* Those allergic to macromolecular drug components or allergic to any research drug, any component or excipient in the drug.
* Received live attenuated vaccines within 4 weeks before treatment.
* Active autoimmune diseases that required systemic treatment (such as using disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years before the first administration.
* Received systemic glucocorticoid treatment or any other form of immunosuppressive therapy or diagnosed with immunodeficiency within 2 weeks before treatment.

Primary outcomes:
measure: Overall response rate (ORR)
timeFrame: Baseline up to 12 months
Secondary outcomes:
measure: Duration of remission (DOR)
timeFrame: Baseline up to 12 months
measure: Progression-free survival (PFS)
timeFrame: Baseline up to 12 months
measure: Overall survival (OS)
timeFrame: Baseline up to 17 months
measure: Disease control rate (DCR)
timeFrame: Baseline up to 12 months
measure: Frequency of adverse event (AE)
timeFrame: From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first
measure: Severity of adverse event (AE)
timeFrame: From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.
measure: Anti-drug antibody (ADA)
timeFrame: Before infusion on cycle1 day1, cycle2 day1,cycle 4 day1, cycle7 day1, cycle12 day1 (each cycle is 21 days), 30 days after the end of the last infusion
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinise Academy of Medical Sciences
state: Beijing
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Provincial Maternal and Child Health Hospital
state: Fujian
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Lanzhou
country: China
facility: GanSu Cancer Hospital
state: Gansu
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou Women and Children's Medical Center
state: Guangdong
city: Meizhou
country: China
facility: Meizhou peoples Hospital
state: Guangdong
city: Qingyuan
country: China
facility: Affiliated Qingyuan Hospital, Guangzhou Medical University,Qingyuan People's Hospital
state: Guangdong
city: Qingyuan
country: China
facility: Affiliated Qingyuan Hospital,Guangzhou Medical University,Qingyuan People's Hospital
state: Guangdong
city: Nanning
country: China
facility: Guangxi Medical University Cancer Hospital
state: Guangxi
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
state: Hebei
city: Tangshan
country: China
facility: Tangshan People's Hospital
state: Hebei
city: Harbin
country: China
facility: Harbin Medical University Cancer Hostipal
state: Heilongjiang
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Zhengzhou
country: China
facility: The Second Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanchang
country: China
facility: Jiangxi Maternal and Child Health Hospital
state: Jiangxi
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Changchun
country: China
facility: Jilin Provincial People's Hospital
state: Jilin
city: Meihekou
country: China
facility: Meihekou Central Hospital
state: Jilin
city: Shenyang
country: China
facility: Liaoning Cancer Hospital
state: Liaoning
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiao Tong University
state: Shaanxi
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Med
state: Shanghai
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer center
state: Shanghai
city: Shanghai
country: China
facility: Obstetrics & Gynecology Hospital of Fudan University
state: Shanghai
city: Chengdu
country: China
facility: West China Second Hospital of Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Hospital
state: Tianjin
city: Urumqi
country: China
facility: Xinjiang Medical University Affiliated Cancer Hospital
state: Xinjiang
city: Hangzhou
country: China
facility: ZheJiang Cancer Hospital
state: Zhejiang
Study officials:
References: