Clinical trial · Interventional
A Phase I/II Clinical Study of LBL-024 in Patients With Advanced Malignant Tumors
A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of LBL-024 in Patients With Advanced Malignant Tumors
NCT05170958CI-TRIAL-00116355recruitingPhase 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)
To evaluate the phase I/II clinical study of LBL-024 in the treatment of 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 Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LBL-024 for Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LBL-024
- description
- LBL-024 injection; Initial dose - MTD; Q3W
- interventionNames
- Drug: LBL-024 for Injection
Primary outcomes (3)
- measure
- Maximum tolerated dose (MTD)
- timeFrame
- All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (Visit 30 days after discontinuation of treatment or withdraw from the visit)
- description
- During the dose-escalation phase, the highest dose of dose-limiting toxicity for subjects less than or equal to 1/6 of the study drug within 3 weeks of starting treatment in Phase I study.
- measure
- Dose-limiting toxicities(DLT)
- timeFrame
- Within 3 weeks after receiving the first dose of the test drug
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 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 in the I/IIa trial phase;18-80 years old (including boundary value), no gender limit in the IIb trial phase; 3. Subject has adequate organ and bone marrow function,Conforming to laboratory test results: 4. The expected survival time is at least 12 weeks 5. ECOG score is 0-1 6. Males with fertility and females of childbearing age are willing to take effective contraceptive measures From the signing of the informed consent form to within 6 months after the last administration of the trial drug (including abstinence, intrauterine device, various hormonal contraception, correct use of contraception Sets,etc); Women of childbearing age include pre-menopausal women and women within 2 years after menopause. Women of childbearing age must have a negative pregnancy test within 7 days before the first trial drug is administered. Exclusion Criteria: 1. Receiving other unmarketed clinical research drugs or treatments within 4 weeks before using the research drug for the first time; 2. Brain parenchymal metastases or meningeal metastases with clinical symptoms, which are not suitable for inclusion in the group by the investigator's judgment; 3. medical history of immunodeficiency including positive HIV antibody test; 4. Women who are pregnant or breastfeeding; 5. 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
No reference posted for this study.