LBL-024 combination treatment for advanced esophageal squamous cell carcinoma (Phase II, Substudy 03)

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 03(ESCC)]

This trial tries LBL-024 combined with chemotherapy and immunotherapy in adults with advanced esophageal squamous cell carcinoma to see if it better controls tumors or prolongs benefit.

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: NCT07331155 on ClinicalTrials.gov

What this trial studies

This is an open-label, multicenter Phase II study testing LBL-024 given with chemotherapy agents (cisplatin, paclitaxel, 5‑fluorouracil) and the PD‑1 inhibitor tislelizumab in patients with advanced ESCC. The study begins with a small safety run‑in where a few subjects receive the combination and are observed for 21 days to confirm tolerability. If the combination is judged safe, the trial expands into a randomized, open, positive‑control phase with subjects assigned 2:1 to experimental versus control groups, enrolling up to 110 people. Key outcomes include tumor response per RECIST 1.1 and safety/tolerability measures, with regular clinical and laboratory monitoring across participating centers.

Who should consider this trial

Good fit: Adults (≥18) with advanced oesophageal squamous cell carcinoma who have ECOG 0–1, at least one measurable lesion by RECIST 1.1, adequate organ and bone marrow function, and expected survival of at least 12 weeks are ideal candidates.

Not a fit: Patients with poor performance status (ECOG ≥2), significant organ dysfunction, inability to comply with visits or contraception requirements, or otherwise ineligible by protocol are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the combination could shrink tumors and extend progression‑free or overall survival compared with current options for advanced ESCC.

How similar studies have performed: Combining chemotherapy with PD‑1 inhibitors has shown benefit in ESCC in other trials, but LBL‑024 is a novel agent and this particular combination regimen is still unproven.

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. 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 (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 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, 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 Cancer Hospital — Beijing, Beijing Municipality, China (RECRUITING)
• AnYang Tumor Hospital — Anyang, Henan, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of Henan University of Science & Technology — Luoyang, Henan, China (RECRUITING)
• Henan Cancer Hospital — Zhengzhou, Henan, China (RECRUITING)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (RECRUITING)
• Shandong Cancer Hospital — Jinan, Shandong, China (RECRUITING)
• Suining Central Hospital — Suining, Sichuan, China (RECRUITING)

Study contacts

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

Conditions: Advanced Solid Tumour