ABOD2011 treatment for advanced solid tumors after standard therapy

An Open-blind Dose Escalation Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ABOD2011 in Patients With Advanced Solid Tumors Progressed After Standard Systemic Therapy

This study is testing a new mRNA treatment called ABOD2011 to see if it can help people with advanced solid tumors that haven't improved after standard therapy.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT05392699 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and tolerability of ABOD2011, a new generation mRNA product designed for intratumoral injection, in patients with advanced solid tumors that have progressed after standard systemic therapy. The study involves administering human single chain IL-12 mRNA either as a single dose or multiple doses. Participants must have measurable lesions suitable for treatment and meet specific health criteria. The trial aims to explore the potential of mRNA technology in enhancing immune response against tumors.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histopathologically confirmed recurrent or metastatic solid tumors that have progressed after standard systemic therapy.

Not a fit: Patients who have received systemic anti-tumor therapy or radiotherapy within the specified time frames prior to the trial may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a novel therapeutic option for patients with advanced solid tumors who have exhausted standard treatment options.

How similar studies have performed: While the use of mRNA technology in cancer treatment is a promising area, this specific approach with ABOD2011 is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. 18 years and older.
2. Understand and voluntarily sign the informed consent form (ICF).
3. Histopathologically confirmed recurrent or metastatic solid tumors.
4. Failure of prior systemic standard of care, or intolerance to severe toxicity, or lack of standard of care.
5. Presence of at least one measurable lesion as assessed by RECIST Version 1.1.
6. At least one superficial or deep lesion for intratumoral administration and biopsy.
7. Sufficient organ functions.
8. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
9. Weight \> 30 kg.
10. Expected survival longer than 12 weeks.
11. Evidence of menopause in female patients, or for women of childbearing potential: negative for urine or blood pregnancy.

Exclusion Criteria:

1. Any systemic anti-tumor therapy, within 28 days prior to the first dose.
2. Radiotherapy within 14 days prior to first dose.
3. Use of immunosuppressants.
4. Major surgery within 28 days.
5. Inadequately controlled diseases.
6. Active autoimmune and inflammatory diseases.
7. Clinically symptomatic central nervous system tumors or metastases.
8. Toxicity of prior anti-tumor therapy is still NCI-CTCAE ≥ 2.
9. Other malignancies within the previous 5 years with the exception of cured basal cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the breast, and carcinoma in situ of the cervix.
10. Active infections.
11. Other conditions that may increase the risk associated with the study drug, or affect the study compliance, etc., which, in the opinion of the investigator, are not suitable for participation in the study.

Where this trial is running

Beijing

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Ning Li, Doctor — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Study coordinator: Dawei Wu, Doctor

Conditions Patients With Advanced Solid Tumors