Clinical trial · Interventional
A Clinical Trial of LBL-024 Combination Drug in Patients With Advanced Solid Tumours[Substudy 02(BTC&HCC)]
An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of LBL-024 in Combination With Other Drugs for the Treatment of Patients With Advanced Solid Tumour[Substudy Number 02(BTC&HCC)]
NCT07111546CI-TRIAL-00124779recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
An open-label, multicenter, phase II clinical study to evaluate the efficacy and safety of LBL-024 in combination with other drugs for the treatment of patients with advanced solid tumour.
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 Tumour | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab Injection | Drug | Bevacizumab | ALIAS |
| Cisplatin Injection | Drug | Cisplatin | ALIAS |
| Gemcitabine Hydrochloride for Injection | Drug | Gemcitabine | ALIAS |
| LBL-024 for Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LBL-024+Gemcitabine Hydrochloride+Cisplatin/LBL-024+Bevacizumab
- description
- Cohort 1： Subjects were treated with LBL-024 combined with gemcitabine and cisplatin Cohort 2： Subjects were treated with LBL-024 combined with Bevacizumab. Intravenous infusion.
- interventionNames
- Drug: LBL-024 for Injection
- Drug: Cisplatin Injection
- Drug: Gemcitabine Hydrochloride for Injection
- Drug: Bevacizumab Injection
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)
- description
- Objective Response Rate (complete response (CR) + partial response (PR)), as assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1), refers to the percentage of study subjects who achieve a complete response or partial response.
Secondary outcomes (5)
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, visit schedule, laboratory test, and other requirements of the protocol, and voluntarily enroll in the study and sign the written informed consent. 2. Age 18-75 years (inclusive of boundaries) at the time of signing informed consent form. 3. The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0\~1. 4. The expected survival time is at least 12 weeks. 5. According to the evaluation of RECIST 1.1 standard, the subjects enrolled have at least one measurable lesion. 6. There is adequate organ and bone marrow function,Conforms to laboratory test results. 7. 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. Exclusion Criteria: 1. Participation in clinical studies of antineoplastic agents within 4 weeks before the first use of study drug,or Subject is expected to receive any other form of systemic or local anti-tumor therapy outside the protocol during the study. 2. Use of immunomodulatory drugs within 2 weeks before the first use of study drug,Including but not limited to thymopeptide, interleukins, interferon, etc. 3. Patients with active infection and requiring intravenous anti-infective therapy within 2 weeks before the first dose. 4. Patients with clinically uncontrollable pleural effusion, pericardial effusion, ascites, and those requiring repeated drainage or medical intervention. 5. The patient has a Medical history of immunodeficiency, including HIV antibody positive. 6. Women during pregnancy or lactation. 7. History of mental illness (interfering with understanding or giving informed consent), drug abuse, alcoholism or drug addiction. 8. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.
References
Publications (0)
Data not yet available
No reference posted for this study.