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New treatment option for Gynecological Tumors
Official title A Clinical Trial of TQB2102 for Injection in Gynecological Tumors With Recurrent/Metastatic Advanced
ClinicalTrials.gov ID: NCT06798207
What this study is testing
What is TQB2102 for injection?
TQB2102 for injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for gynecological tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- people 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...
- 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 people with completely negative IHC 0 staining are...
- Previous chemotherapy with platinum-based drugs was unsuccessful.
You likely can't join 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.
- people with a history of interstitial lung disease/pneumonia ( non-infectious type ) that required steroid drug intervention treatment in the past...
- people with moderate to severe pulmonary dysfunction/disease within 3 months before the first administration.
See the full eligibility criteria
- people 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 people 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...
- 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.
- people 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...
- people 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.
- people 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...
- 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...
- people with known central nervous system metastasis and/or carcinomatous meningitis, with diffuse dissemination. people 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Fuzhou, Fujian, China
- Lanzhou, Gansu, China
- Guangzhou, Guangdong, China
- Meizhou, Guangdong, China
- Qingyuan, Guangdong, China
- Nanning, Guangxi, China
- Shijiazhuang, Hebei, China
- Tangshan, Hebei, China
- Harbin, Heilongjiang, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Nanchang, Jiangxi, China
- Changchun, Jilin, China
- Meihekou, Jilin, China
- Shenyang, Liaoning, China
- Xi'an, Shaanxi, China
- Shanghai, Shanghai Municipality, China
+ 4 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Fuzhou, Fujian, China; Lanzhou, Gansu, China; Guangzhou, Guangdong, China; Meizhou, Guangdong, China and 18 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.