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

Overview

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.

Interventions

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

Primary outcome measures

• Overall response rate (ORR) [Time frame: Baseline up to 12 months]

Secondary outcome measures (7)

• Duration of remission (DOR) [Time frame: Baseline up to 12 months]
• Progression-free survival (PFS) [Time frame: Baseline up to 12 months]
• Overall survival (OS) [Time frame: Baseline up to 17 months]
• Disease control rate (DCR) [Time frame: Baseline up to 12 months]
• Frequency of adverse event (AE) [Time frame: From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first]
• Severity of adverse event (AE) [Time frame: From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.]
• Anti-drug antibody (ADA) [Time frame: 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 31 centers

• Cancer Hospital Chinise Academy of Medical Sciences — Beijing
• Chongqing University Cancer Hospital — Chongqing
• Fujian Provincial Maternal and Child Health Hospital — Fuzhou
• Fujian Cancer Hospital — Fuzhou
• GanSu Cancer Hospital — Lanzhou
• Sun Yat-sen University Cancer Center — Guangzhou
• Guangzhou Women and Children's Medical Center — Guangzhou
• Meizhou peoples Hospital — Meizhou
• … and 23 more centers

Identifiers

NCT: NCT06798207 · TQB2102-II-05

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗