A Study of TQB2102 for Injection in Patients With Recurrent/Metastatic Breast Cancer

NCT06115902 | Recruiting Phase 1

• 1 other identifier: TQB2102-Ib-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 20

Brief Summary

TQB2102 is an antibody-drug conjugate comprised of a humanised antibody against Human Epidermal Growth Factor Receptor 2 (HER2), an 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 1/Phase 2 study to evaluate the effectiveness, safety, pharmacokinetics (PK) and anti-drug antibody (ADA) of TQB2102 for injection in subjects with HER2-expressing relapsed/metastatic breast cancer.

Conditions

Breast Cancer

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 10 months.

Secondary Outcomes (11)

• Progression-Free Survival (PFS)

  Baseline up to 14 months.

• Duration of Remission (DOR)

  Baseline up to 14 months.

• Disease Control Rate (DCR)

  Baseline up to 10 months.

• Clinical Benefit Rate (CBR)

  Baseline up to 14 months.

• Overall Survival (OS)

  Baseline up to 20 months.

Study Arms (1)

TQB2102 for injection

EXPERIMENTAL

Dose: 6.0 mg/kg or 7.5 mg/kg of TQB2102 for injection. Administration: 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 - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects voluntarily participate in this study and sign informed consent;
• Between the ages of 18-75 years (subject to the date of signing the informed consent); Eastern cooperative oncology group (ECOG) score 0-1; estimated survival time ≥3 months;
• Breast cancer patients diagnosed with HER2 expression by pathological examination, with evidence of local focal recurrence or distant metastasis, are not suitable for surgery or radiotherapy for cure;
• Disease progression or intolerance during or after the most recent treatment period must be present before participating in clinical trials;
• At least one measurable lesion (based on Response Evaluation Criteria In Solid Tumors 1.1);
• The main organs function are normally;
• Female participants of childbearing age should agree to use contraception during the study period and for 6 months after the end of the study; Have a negative serum pregnancy test within 7 days prior to study enrollment and must be a non-lactating subject; Male participants should agree that contraception must be used during the study period and for 6 months after the end of the study period.

You may not qualify if:

• Concomitant disease and medical history:
• Has diagnosed and/or treated additional malignancy within 3 years prior to first administration of study drug;
• Adverse effects due to any prior treatment have not been restored according to CommonTerminology Criteria for Adverse Events (CTCAE) 5.0 ≤ level 1 (Excluding hair loss);
• Major surgical treatment, incision biopsy, or significant traumatic injury received within 28 days prior to study treatment;
• Long-term unhealed wounds or fractures;
• Patients who have a prior history of interstitial lung disease/pneumonia requiring steroid intervention, or who are present with interstitial lung disease/pneumonia, or who are suspected of having interstitial lung disease/pneumonia on screening imaging and cannot be ruled out;
• Arterial/venous thrombosis events, such as cerebrovascular accident, deep vein thrombosis, and pulmonary embolism, occurred within 6 months before the first medication;
• Patients who have a history of psychotropic substance abuse and are unable to abstain or have mental disorders;
• Patients with any severe and/or uncontrolled disease;
• Tumor related symptoms and treatment:
• Patients who have been treated with other antitumor drug, such as chemotherapy, radical radiotherapy, or immunotherapy, within 4 weeks prior to the first dose, or who are still within 5 half-lives of the drug;
• Received Chinese patent drugs with anti-tumor indications specified in the National Medical Products Administration (NMPA) approved drug instructions within 2 week before the study treatment;
• Patients whose imaging shows that the tumor has invaded important blood vessels or who are determined by the investigators to be highly likely to invade important blood vessels during follow-up studies and cause fatal major bleeding;
• Uncontrolled pleural effusion, ascites, and moderate or higher pericardial effusion requiring repeated drainage;
• Known presence of cancerous meningitis or clinically active central nervous system metastasis; Patients who have been stable for at least 4 weeks after treatment and have been off corticosteroids for at least 2 weeks are excluded;

Sponsors & Collaborators

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

Study Sites (20)

Anhui Pronvincial Cancer Hospital

Hefei, Anhui, 230000, China

NOT YET RECRUITING

Lu'an People's Hospital

Lu'an, Anhui, 237008, China

NOT YET RECRUITING

Cancer Hospital Chinese Academy of Medical Science

Beijing, Beijing Municipality, 100021, China

NOT YET RECRUITING

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

NOT YET RECRUITING

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Jiangmen Central Hospital

Jiangmen, Guangdong, 529000, China

NOT YET RECRUITING

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, 530021, China

NOT YET RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410031, China

NOT YET RECRUITING

Ganzhou People's Hospital

Ganzhou, Jiangxi, 341000, China

NOT YET RECRUITING

Jilin Cancer Hospital

Changchun, Jilin, 130012, China

NOT YET RECRUITING

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, 110000, China

NOT YET RECRUITING

The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

NOT YET RECRUITING

Cancer Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, 250117, China

NOT YET RECRUITING

Linyi Cancer Hospital

Linyi, Shandong, 276034, China

NOT YET RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University School of Medicine

Xi'an, Shannxi, 710089, China

NOT YET RECRUITING

Shanxi Cancer Hospital

Taiyuan, Shanxi, 030000, China

NOT YET RECRUITING

Suining Central Hospital

Suining, Sichuan, 629000, China

NOT YET RECRUITING

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300202, China

NOT YET RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

NOT YET RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Injections

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Qingyuan Zhang, Doctor

CONTACT

+86 13312612989; 13313612989@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 3, 2023
• Study Start: November 17, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 29, 2023

Record last verified: 2023-10

Locations

CN (20)