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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-17

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TQB2102 for injection

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.

Group Type EXPERIMENTAL

TQB2102 for injection

Intervention Type DRUG

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

Interventions

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TQB2102 for injection

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Concomitant disease and medical history:

1. Has diagnosed and/or treated additional malignancy within 3 years prior to first administration of study drug;
2. 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);
3. Major surgical treatment, incision biopsy, or significant traumatic injury received within 28 days prior to study treatment;
4. Long-term unhealed wounds or fractures;
5. 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;
6. Arterial/venous thrombosis events, such as cerebrovascular accident, deep vein thrombosis, and pulmonary embolism, occurred within 6 months before the first medication;
7. Patients who have a history of psychotropic substance abuse and are unable to abstain or have mental disorders;
8. Patients with any severe and/or uncontrolled disease;
* Tumor related symptoms and treatment:

1. 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;
2. 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;
3. 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;
4. Uncontrolled pleural effusion, ascites, and moderate or higher pericardial effusion requiring repeated drainage;
5. 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;
6. Patients with severe bone injury due to tumor bone metastasis;
* Study treatment related: people who are known to be allergic to the study drug or its excipients, or to humanized monoclonal antibody products;
* Patients who participated in and used other anti-tumor clinical trials within 4 weeks before the first medication;
* In the judgment of the investigator, there is a situation that seriously endangers the safety of the subjects or affects the completion of the study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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