Clinical trial · Interventional
Clinical Trial of the TQB2102 Injection in Patients With Advanced Cancers
A Phase I Study of TQB2102 Injection in Patients With Advanced Cancers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TQB2102 injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TQB2102 injection
- description
- intravenous infuse TQB2102 injection every three weeks, 21 days as a treatment cycle. (1.5mg/kg, 3mg/kg, 4.5mg/kg, 6mg/kg, 7.5mg/kg, 9mg/kg)
- interventionNames
- Drug: TQB2102 injection
Primary outcomes (4)
- measure
- Dose Limiting Toxicity (DLT)
- timeFrame
- During the first treatment cycle (21 days).
- description
- DLT was defined as toxicities that meet pre-defined severity criteria (according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0) toxicity assessment criteria), and assessed as having a suspected relationship to study drug that occurred within the first cycle (21 days) of treatment.
- measure
- Maximum tolerated dose (MTD)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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 tumo; * 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.
References
Publications (0)
Data not yet available