A Clinical Trial of TQB2102 for Injection in Gynecological Tumors With Recurrent/Metastatic Advanced

NCT06798207 | Recruiting Phase 2

• 1 other identifier: TQB2102-II-05
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 31

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.

Conditions

Gynecological Tumors

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  ORR defined as percentage of participants achieving complete response (CR) and partial response (PR)

  Baseline up to 12 months

Secondary Outcomes (7)

• Duration of remission (DOR)

  Baseline up to 12 months

• Progression-free survival (PFS)

  Baseline up to 12 months

• Overall survival (OS)

  Baseline up to 17 months

• Disease control rate (DCR)

  Baseline up to 12 months

• Frequency of adverse event (AE)

  From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first

Study Arms (1)

TQB2102 for injection

EXPERIMENTAL

Intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle

Drug: TQB2102 for injection

Interventions

TQB2102 for injection DRUG

TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC).

TQB2102 for injection

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.: lead

Study Sites (31)

Cancer Hospital Chinise Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

NOT YET RECRUITING

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

NOT YET RECRUITING

Fujian Provincial Maternal and Child Health Hospital

Fuzhou, Fujian, 350000, China

NOT YET RECRUITING

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

RECRUITING

GanSu Cancer Hospital

Lanzhou, Gansu, 730050, China

NOT YET RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

NOT YET RECRUITING

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, 510623, China

NOT YET RECRUITING

Meizhou peoples Hospital

Meizhou, Guangdong, 514000, China

NOT YET RECRUITING

Affiliated Qingyuan Hospital, Guangzhou Medical University,Qingyuan People's Hospital

Qingyuan, Guangdong, 511518, China

RECRUITING

Affiliated Qingyuan Hospital,Guangzhou Medical University,Qingyuan People's Hospital

Qingyuan, Guangdong, 511518, China

NOT YET RECRUITING

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, 53000, China

NOT YET RECRUITING

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

NOT YET RECRUITING

Tangshan People's Hospital

Tangshan, Hebei, 63000, China

NOT YET RECRUITING

Harbin Medical University Cancer Hostipal

Harbin, Heilongjiang, 150040, China

NOT YET RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

NOT YET RECRUITING

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450014, China

NOT YET RECRUITING

Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

NOT YET RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

NOT YET RECRUITING

Jiangxi Maternal and Child Health Hospital

Nanchang, Jiangxi, 330077, China

NOT YET RECRUITING

Jilin Cancer Hospital

Changchun, Jilin, 130012, China

NOT YET RECRUITING

Jilin Provincial People's Hospital

Changchun, Jilin, 130021, China

NOT YET RECRUITING

Meihekou Central Hospital

Meihekou, Jilin, 135000, China

NOT YET RECRUITING

Liaoning Cancer Hospital

Shenyang, Liaoning, 110044, China

NOT YET RECRUITING

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi'an, Shaanxi, 710000, China

NOT YET RECRUITING

Ruijin Hospital, Shanghai Jiaotong University School of Med

Shanghai, Shanghai Municipality, 200025, China

NOT YET RECRUITING

Fudan University Shanghai Cancer center

Shanghai, Shanghai Municipality, 200032, China

NOT YET RECRUITING

Obstetrics & Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, 200090, China

NOT YET RECRUITING

West China Second Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

NOT YET RECRUITING

Tianjin Medical University Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

NOT YET RECRUITING

Xinjiang Medical University Affiliated Cancer Hospital

Ürümqi, Xinjiang, 830011, China

NOT YET RECRUITING

ZheJiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

NOT YET RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Jundong Li, Master

CONTACT

13602859865; lijd@sysucc.org.cn

Yang Sun, Doctor

CONTACT

15959028989; doctorsunyang@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: January 29, 2025
• Study Start: March 13, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 18, 2025

Record last verified: 2024-12

Locations

CN (31)