Clinical trial · Interventional
Phase I/II Clinical Trial of LBL-015 for Injection
A Multicenter, Open-label, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of LBL-015 in Patients With Advanced Malignant Tumors.
NCT05107011CI-TRIAL-00081983completedPhase 1 / Phase 2ClinicalTrials.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)
A Multicenter, Open-label, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of LBL-015 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-015 for Injections | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LBL-015
- description
- Drug: LBL-015 for Injection,Initial dose - MTD; Q2W
- interventionNames
- Drug: LBL-015 for Injections
Primary outcomes (2)
- measure
- Maximum tolerated dose (MTD)
- timeFrame
- 28 days after the first dose.
- 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. It was used to evaluate the tolerability.
- measure
- Dose-limiting toxicities(DLT)
- timeFrame
- 28 days after the first dose
- 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. Agree to follow the trial treatment regimen and visit schedule, voluntarily enroll in the study, and sign the written informed consent form; 2. Age ≥18 and ≤75 years old at the time of signing the informed consent form, regardless of gender; 3. Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale; 4. Have a life expectancy of at least 12 weeks; 5. There is adequate organ and bone marrow function,Conforms to laboratory test results; 6. Fertile men and women of childbearing age are willing to take effective contraceptive measures (including abstinence, intrauterine devices, hormonal contraception, and correct use of condoms) from the signing of the informed consent form to 6 months after the last dose of the investigational drug; women of childbearing age include premenopausal women and women who had menopause less than two years ago. Blood pregnancy test results must be negative for women of childbearing age within 7 days prior to the initial dose of the investigational drug. Exclusion Criteria: 1. Received other unapproved investigational drug or treatment within 4 weeks prior to first dose of investigational drug; 2. Subjects who underwent major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the initial use of the investigational drug, or require elective surgery during the trial period; 3. Use of immunomodulatory drugs within 14 days prior to the initial use of the investigational drug, including but not limited to thymosin, interleukin, and interferon; 4. Subjects with an active infection that currently requires intravenous anti infective therapy; 5. History of immunodeficiency, including positive HIV antibody test results; 6. Pregnant or lactating women; 7. 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.