A Phase II Clinical Study of LBL-024 Combination Therapy in Patients With Advanced Solid Tumour[Substudy 04]

Nanjing Leads Biolabs

Status and phase: Begins enrollment in 1 month; Phase 2

Conditions: Advanced Solid Tumour

Treatments: Drug: Oxaliplatin injection; Drug: Tislelizumab Injection; Drug: Capecitabine tablets; Drug: LBL-024 for Injection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07390383

LBL-024-CN004_04

Details and patient eligibility

About

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.

Full description

This trial is an open-label, multicenter, phase II clinical study of LBL-024 in combination with other drugs for the treatment of patients with locally advanced or metastatic adenocarcinoma of the gastric or gastroesophageal junction,to evaluate the efficacy and safety of LBL-024 combination therapy.

This study will have a safety run-in period in which a small number of subjects will be enrolled to receive LBL-024 combination therapy.After the subjects completed the 21-day safety observation, the sponsor and investigator jointly assessed the safety and tolerability of the combination drugs. If safety and tolerability are good, the extension study of combination administration will be continued, the subjects will be continued to be enrolled, and the randomized, open, positive control trial design will be adopted.Subjects who meet the criteria will be randomly assigned to the experimental group and the control group in a ratio of 2: 1.

This trial will enroll up to 110 subjects.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 years at the time of signing the informed consent.
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 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. Patients with histologically confirmed unresectable locally advanced or metastatic gastric/gastroesophageal junction (G/GEJ) adenocarcinoma.
7. There is adequate organ and bone marrow function,Conforms to laboratory test results.
8. 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. Participation in clinical studies of antineoplastic agents within 4 weeks before the first use of study drug,or is expected to receive any other form of systemic 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, or who have had and have the possibility of recurrence of autoimmune diseases.
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. Active hepatitis B or active hepatitis C.
7. Women during pregnancy or lactation.
8. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

LBL-024+Oxaliplatin+capecitabine

Experimental group

Description:

LBL-024+Oxaliplatin+capecitabine. Capecitabine is orally administered and other drugs are Intravenous infusion.

Treatment:

Drug: Capecitabine tablets

Drug: Oxaliplatin injection

Drug: LBL-024 for Injection

Tislelizumab+Oxaliplatin+capecitabine+LBL-024

Active Comparator group

Description:

Tislelizumab+Oxaliplatin+capecitabine+LBL-024. Capecitabine is orally administered and other drugs are Intravenous infusion.

Treatment:

Drug: Tislelizumab Injection

Drug: Capecitabine tablets

Drug: Oxaliplatin injection

Drug: LBL-024 for Injection