Clinical trial · Interventional
A Phase Ib/II Clinical Trial of LBL-007 Combined With Tislelizumab in the Treatment of Malignant Tumors
A Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LBL-007 in Combination With Tislelizumab in the Treatment of Malignancies
NCT05516914CI-TRIAL-00107007completedPhase 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)
This trial is an open and multicenter phase Ib/II clinical study, which aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and effectiveness.
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 |
|---|---|---|---|
| Malignant Tumors | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin Injection | Drug | Cisplatin | ALIAS |
| Docetaxel injection | Drug | Docetaxel | ALIAS |
| Gemcitabine Hydrochloride for Injection | Drug | Gemcitabine | ALIAS |
| LBL-007 Injection | Drug | — | UNRESOLVED |
| Tislelizumab Injection | Drug | Tislelizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LBL-007 & Tislelizumab
- description
- LBL-007 Injection; dose A or dose B; Q3W
- interventionNames
- Drug: LBL-007 Injection
- Drug: Tislelizumab Injection
- Drug: Cisplatin Injection
- Drug: Gemcitabine Hydrochloride for Injection
- Drug: Docetaxel injection
Primary outcomes (3)
- measure
- Objective Response Rate (ORR)
- timeFrame
- All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (30+7 days after drug withdrawal or before the start of new anti-tumor therapy
- description
- ORR (complete response (CR) + partial response (PR)), as assessed by Response Evaluation Criteria in Solid Tumors (RECIST), refers to the percentage of study subjects who achieve a complete response or partial response
- measure
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 experimental treatment plan and visit plan, join the group voluntarily, and sign a written informed consent form; 2. Age ≥ 18 and ≤ 75 years old when signing the informed consent form, regardless of gender; 3. The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) PS is 0\~1; 4. The expected survival time is at least 12 weeks; 5. According to the evaluation criteria for the efficacy of solid tumors (RECIST 1.1), the subjects enrolled have at least one measurable tumor lesion; 6. Subject has adequate organ and bone marrow function 7. Males with fertility and females of childbearing age are willing to take effective contraceptive measures (including abstinence, intrauterine device, various hormonal contraception, correct use of contraception from the signing of the informed consent form to 6 months after the last administration of the trial drug 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. Have received other unmarketed clinical research drugs or treatments within 4 weeks before using the research drug for the first time; 2. Those who have clinically uncontrollable pleural effusion, pericardial effusion or ascites, requiring repeated drainage or medical intervention; 3. Women during pregnancy or lactation; 4. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study. 5. Patients with history of severe cardiovascular and cerebrovascular diseases. 6. Patients with active infection and currently requiring intravenous anti-infective treatment
References
Publications (0)
Data not yet available
No reference posted for this study.