Clinical trial
A Phase I Study of TQB2102 Injection in Patients With Advanced Cancers
Name
TQB2102-I-01
Description
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 I study to evaluate the safety, tolerability and effectiveness of TQB102 injection in subjects with advanced malignancies.
Trial arms
Trial start
2023-02-01
Estimated PCD
2024-04-01
Trial end
2024-10-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
TQB2102 injection
TQB2102 is an antibody-drug conjugate comprised of a humanised antibody against HER2, a enzyme-cleavable linker, and a topoisomerase I inhibitor payload.
Arms:
TQB2102 injection
Size
71
Primary endpoint
Dose Limiting Toxicity (DLT)
During the first treatment cycle (21 days).
Maximum tolerated dose (MTD)
During the first treatment cycle (21 days).
The occurrence rate of all adverse events (AEs)
From date of the first dose until 28 days after last dose or new anti-tumor treatment, whichever came first.
The severity of all adverse events (AEs)
From date of the first dose until 28 days after last dose or new anti-tumor treatment, whichever came first.
Eligibility criteria
Inclusion Criteria:
* Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study;
* Male or female patient 18 to 75 years of age, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, and life expectancy ≥12 weeks;
* Histologically or cytologically confirmed, locally advanced tumors, Priority will be given to subjects with HER2 positive solid tumor;
* Malignant tumor that failed from standard treatment or had no standard treatment;
* According to the RECIST 1.1 standard, patient with at least one evaluable lesion;
* The main organs function well;
* Male or female patient had no plans to become pregnant and voluntarily took effective contraceptive measures from agree with the study to at least 6 months after the last dose of study drug.
Exclusion Criteria:
* Concurrent secondary malignancy or other malignancy with no evidence of disease for more than 3 years;
* History of uncontrolled intercurrent illness;
* Major surgical procedure, radiotherapy, chemotherapy, or immunotherapy within 4 weeks prior to first dose;
* Patients with known symptomatic brain metastases;
* Receiving any other investigational agent within 4 weeks before first dose;
* Patients with severe hypersensitivity after the use of monoclonal antibodies
* History of interstitial lung disease or pneumonia;
* Unstable or serious concurrent medical conditions, as assessed by the Investigators, that would substantially increase the risk-benefit ratio of participating in the study.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 71, 'type': 'ESTIMATED'}}
Updated at
2023-02-27
1 organization
1 product
1 indication
Product
TQB2102Indication
Advanced Cancer