A Clinical Trial Evaluating Injection of TQB6411 in Subjects With Advanced Malignant Tumors

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

About this trial

TQB6411 for injection is an antibody-conjugated drug (ADC) targeting EGFR/c-Met. After injecting blood intravenously, the antibody part of this product binds to the surface of EGFR and c-Met on tumor cells to block the activation of EGFR and c-Met signaling pathways. The ADC is enzymatically transported to the lysosome. The linker releases toxins after enzyme cleavage, resulting in DNA damage and cell death. TQB6411 for injection is intended for the treatment of advanced malignant tumors.

Eligibility criteria

Qualifiers

The subjects voluntarily joined the study, signed an informed consent form, and had good compliance;

18 years old≤age age≤75 years old (calculated based on the date of signing the informed consent form);

Eastern Cooperative Oncology Group (ECOG) score 0~1 point;

Expected survival is greater than 12 weeks;

Disqualifiers

Have appeared or are currently suffering from other malignant tumors;

There are diseases that affect intravenous injection and intravenous blood collection;

The adverse reactions of previous treatments failed to recover to CTCAE V5.0 grade score ≤1, except for toxicity without safety risk, such as grade 2 hair loss, grade 2 peripheral nerve toxicity, grade 2 anemia, non-clinical significance and asymptomatic grade 2 laboratory abnormalities, stable hypothyroidism with hormone replacement therapy;

Those who have received major surgical treatment, obvious traumatic injury or major surgery during the expected study treatment within 4 weeks before the first medication (except for the surgery stipulated in the program), or have long-term uncured wounds or fractures;

Trial design

Treatments tested in this trial

  • TQB6411 injection

Treatment groups

216 Participants
are divided into 1 treatment group