Clinical trial · Interventional
Evaluation of LBL-003 Phase I Study in Patients With Advanced Malignancies
Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of LBL-003 Injection in Patients With Advanced Malignancies
NCT05042908CI-TRIAL-00077322completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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 study is a single-arm, dose-escalation phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of LBL-003 injection 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 Tumor | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LBL-003 Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LBL-003
- description
- Drug: LBL-003 injection ; Initial dose - MTD; Q2W
- interventionNames
- Drug: LBL-003 Injection
Primary outcomes (2)
- measure
- Maximum tolerated dose (MTD)
- timeFrame
- Within 4 weeks after receiving the first dose of the test drug
- description
- MTD is defined as the hightest dose level at which no more than 1 out of 6 subjects experiences a DLT during the first cycles.
- measure
- Dose-limiting toxicities（DLT）
- timeFrame
- Within 4 weeks after receiving the first dose of the test drug
- description
- DLT describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment. It was used to evaluate the safety.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Both male and female aged 18-75 years (including borderline values) at the time of signing the informed consent form; 2. ECOG score: 0-1; 3. Agree to follow the study treatment plan and visit plan, voluntarily enrolls, and signs the written informed consent. 4. Subjects with advanced malignant solid tumors confirmed by histology or cytology have failed the standard treatment or have no standard treatment protocol or are not suitable for standard treatment at this stage. 5. Subjects should have at least one evaluable lesion as defined by RECIST V1.1; 6. Subjects are expected to survive at least 12 weeks; Exclusion Criteria: 1. History of immunodeficiency, including positive HIV antibody test results； 2. Active hepatitis (hepatitis B or C)； 3. having undergone major surgery or still in the recovery phase of an earlier surgery within 4 weeks before the first administration; 4. Women during pregnancy or lactation; 5. The investigator's assessment that there may be other factors affecting compliance among participants or that some may not be suitable for inclusion in this study.
References
Publications (0)
Data not yet available
No reference posted for this study.