Evaluating a new injection combined with PD-1 for advanced solid tumors

An Exploratory Clinical Study to Evaluate the Safety, Tolerability, Immune Response and Preliminary Efficacy of LM103 Injection in Combination With PD-1 in Patients With Advanced Solid Tumours

This study is testing a new injection combined with PD-1 therapy to see if it can help people with advanced solid tumors that haven't responded to other treatments.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Suzhou BlueHorse Therapeutics Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, cyclophosphamide, fludarabine
• Locations: 1 site (China, Tianjin Municipality)
• Trial ID: NCT06697665 on ClinicalTrials.gov

What this trial studies

This exploratory clinical study assesses the safety, tolerability, immune response, and preliminary efficacy of LM103 Injection when used alongside PD-1 therapy in patients with advanced solid tumors. The treatment regimen includes LM103 injection, IL-2 therapy, PD-1 therapy, fludarabine, and cyclophosphamide. Patients with advanced solid tumors that have not responded to standard treatments will be enrolled, and their tumors will be evaluated for potential surgical resection or biopsy. The study aims to gather data on how well this combination therapy works in this patient population.

Who should consider this trial

Good fit: Ideal candidates include patients with advanced solid tumors such as melanoma, cervical cancer, ovarian cancer, head and neck squamous cell cancer, and non-small cell lung cancer who have failed standard treatments.

Not a fit: Patients with a history of other malignant tumors or those who do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced solid tumors who have limited treatment alternatives.

How similar studies have performed: While this approach is exploratory, similar combination therapies have shown promise in other studies, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. The expected survival time is not less than 3 months.
2. Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0-1.
3. Patients with advanced solid tumors confirmed by histology or cytology: advanced Melanoma, cervical cancer/ovarian cancer, head and neck squamous cell cancer, non-small cell lung cancer, esophageal cancer and other solid tumors that have failed standard treatment regimens, cannot tolerate standard treatment, refuse or do not have standard treatment regimens available.
4. The patient has lesions that can be used for surgical resection (\>1.5 cm3) or biopsy puncture (no less than 6 lesions) for LM103 manufacturing.
5. At least one measurable lesion as the target lesion after collecting tumor tissue from the patient (RECIST v1.1 criteria).
6. Laboratory tests results during the screening period indicate that the subjects have sufficient organ function.

Exclusion Criteria:

1. Have a medical history of other malignant tumors other than the disease under study in the past 5 years, except for malignant tumors that can be expected to recover after treatment (including but not limited to thyroid cancer, cervical Carcinoma in situ, basal or squamous cell skin cancer or Ductal carcinoma in situ of the breast treated by radical surgery).
2. LM103 received systematic therapy of antineoplastic drugs (including chemotherapy, small molecule targeted drug therapy, Hormone replacement therapy, etc.), or local antineoplastic therapy (such as radiotherapy, palliative radiotherapy for bone metastases\>2 weeks before the start of the study and intracranial stereotactic radiotherapy or resection of a single brain metastasis\>3 weeks before the start of the study were acceptable) within 4 weeks before LM103 infusion; Or received clinical investigational drugs or equipment treatment.
3. Adverse reactions caused by previous treatment have not recovered to CTCAE (version 5.0) level 1 or below (excluding hair loss and neurotoxicity, which have been determined by the researchers to be irreparable and level 2 hypothyroidism for a long time).
4. Previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation.

Where this trial is running

China, Tianjin Municipality

• Tianjin Beichen Hospital — China, Tianjin Municipality, China (Recruiting)

Study contacts

• Study coordinator: fenge L doctor

Conditions Solid Cancer