LBL-024 combined with chemotherapy and immunotherapy for advanced gastric or gastroesophageal junction adenocarcinoma

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 04]

This study will test whether adding LBL-024 to capecitabine, oxaliplatin, and tislelizumab helps adults with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Nanjing Leads Biolabs Co.,Ltd (industry)
• Locations: 7 sites (Beijing, Beijing Municipality and 6 other locations)
• Trial ID: NCT07390383 on ClinicalTrials.gov

What this trial studies

This is an open-label, multicenter Phase II trial enrolling up to 110 adults with unresectable locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma. The study begins with a small safety run-in where a few patients receive the LBL-024 combination and are observed for 21 days for tolerability. If the combination is judged safe, the trial expands into a randomized, open-label comparison with participants assigned 2:1 to the experimental combination versus a positive control regimen. Key treatments include LBL-024 for injection given with capecitabine, oxaliplatin, and the PD-1 inhibitor tislelizumab, and outcomes will include safety and measures of tumor response.

Who should consider this trial

Good fit: Adults aged 18 or older with histologically confirmed unresectable locally advanced or metastatic gastric/G‑GEJ adenocarcinoma, ECOG 0–1, at least one measurable lesion by RECIST 1.1, adequate organ and marrow function, and willing to follow trial procedures and contraception requirements.

Not a fit: Patients with other tumor types, poor performance status (ECOG >1), significant organ dysfunction, or who cannot comply with study visits or contraceptive requirements are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, adding LBL-024 to standard chemotherapy and immunotherapy could increase tumor response rates and prolong progression-free or overall survival for these patients.

How similar studies have performed: Combinations of PD‑1 inhibitors with chemotherapy have shown benefit in gastric/GEJ cancer, but LBL-024 is a novel agent and combinations that include it have limited prior data.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality and 6 other locations

• Beijing GoBroad Hospital — Beijing, Beijing Municipality, China (NOT_YET_RECRUITING)
• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (RECRUITING)
• The Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (NOT_YET_RECRUITING)
• Shandong Cancer Hospital — Jinan, Shandong, China (NOT_YET_RECRUITING)
• The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (NOT_YET_RECRUITING)
• Shanxi Provincial Cancer Hospital — Taiyuan, Shanxi, China (NOT_YET_RECRUITING)
• Tianjin Medical University Cancer Institute & Hospital — Tianjin, Tianjin Municipality, China (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Lin Shen — Peking University Cancer Hospital & Institute
• Study coordinator: Lin Shen

Conditions: Advanced Solid Tumour