Clinical trial · Interventional
TQB2223 Injection in Combination With Penpulimab in Patients With Advanced Cancers
Phase I Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of TQB2223 Injection Combined With Penpulimab Injection in Subjects 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)
TQB2223 is a recombinant, fully humanized antibody that binds lymphocyte activation gene-3 (LAG-3) and blocks the LAG-3/ major histocompatibility complex class II (MHC-II) interaction, thus allowing for increased T-cell proliferation and cytokine production. This is a phase I study to evaluate the safety, tolerability, pharmacokinetics (PK) and effectiveness of TQB2223 injection in combination with Penpulimab in subjects with advanced cancers.
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 |
|---|---|---|---|
| TQB2223 injection+ Penpulimab Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TQB2223 injection+ Penpulimab Injection
- description
- intravenous injection of TQB2223 injection and Penpulimab injection for one times every three weeks, 21 days as a treatment cycle.
- interventionNames
- Drug: TQB2223 injection+ Penpulimab Injection
Primary outcomes (3)
- measure
- Dose Limiting Toxicity (DLT)
- timeFrame
- During the first treatment cycle (21 days).
- description
- DLT is defined as toxicities that meet pre-defined severity criteria of Common Terminology Criteria for Adverse Events (CTCAE) v5.0, and assessed as having a suspected relationship to TQB2223 injection, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs 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 ≥3 months; * Histologically or cytologically confirmed malignancies; * Subjects with advanced malignant tumors who failed standard treatment or lacked effective treatment; * Patient has at least one evaluable lesion assessed by RECIST 1.1; * The main organs function is well; * Male or female patient had no plans to become pregnant and voluntarily take effective contraceptive measures during study period until 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 5 years; * History of uncontrolled intercurrent illness; * Major surgical procedure, radiotherapy, chemotherapy, or immunotherapy within 4 weeks prior to first dose; * Prior treatment targeting LAG-3; * 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