Clinical trial · Interventional
Evaluation of LBL-019 Monotherapy or Combined With Anti-PD-1 Antibody in the Treatment of Advanced Malignant Tumors
A Multicenter, Open Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of LBL-019 Monotherapy or Combination Anti-PD-1 Antibody in Patients With Advanced Malignant Tumors
- 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)
This trial is a phase I/II study, which is designed to evaluate the safety, tolerance, pharmacokinetic characteristics, receptor occupancy (RO), immunogenicity and effectiveness of LBL-019 monotherapy or combined with anti-PD-1 antibody in patients with advanced malignant tumors.
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 Malignant Tumors | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anti-PD-1 antibody injection | Drug | — | UNRESOLVED |
| LBL-019 Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LBL-019
- description
- singal -arm
- interventionNames
- Drug: LBL-019 Injection
- Drug: anti-PD-1 antibody injection
Primary outcomes (1)
- measure
- safety and tolerability
- timeFrame
- All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal. The maximum time is 24 months
- description
- To evaluate the safety, tolerability of LBL-019 monotherapy or combined with anti-PD-1 antibody, which is according to the number of DLT and the number of treatment related AES
Secondary outcomes (6)
- measure
- Cmax
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1.Agree to comply with the trial treatment plan and visit plan, voluntarily agree to sign the informed consent form; 2.18-75 years old (including boundary value), no gender limit; 3\. previous standard treatment failed, no standard treatment or standard treatment is not applicable at this stage; 4.The expected survival time is at least 12 weeks; Exclusion Criteria: 1. Have received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks before using the study drug for the first time; 2. Received any other investigational drug or treatment that is not on the market within 4 weeks prior to the initial use of the investigational drug; 3. Women who are pregnant or breastfeeding; 4. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in the study
References
Publications (0)
Data not yet available