Clinical trial NCT05392699: ABOD2011 in Patients With Advanced Solid Tumors Progressed After Standard Systemic Therapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Patients With Advanced Solid Tumors
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Based on the activation and regulation of immune system by cytokines, mRNA encoding cytokines has become one of the important directions of mRNA tumor drug development. This product (ABOD2011) is a new generation mRNA product for intratumoral injection.

The primary objective of this study is to assess the safety and tolerability, of ABOD2011 in patients with advanced solid tumors that progressed after standard systemic therapy.


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.

Primary outcomes:
measure: Number of Participants Experiencing dose-limiting toxicities (DLTs)
timeFrame: From first dose to Day 28
measure: Number of Participants Experiencing Adverse Events (AEs)
timeFrame: From signed ICF until the date of last visit or start new antitumor therapy, whichever comes first, assessed up to 36 months
measure: Number of Participants Experiencing Severe Adverse Events (SAEs)
timeFrame: From signed ICF until the date of last visit or start new antitumor therapy, whichever came first, assessed up to 24 months
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Up to 36 months
measure: Disease Control Rate(DCR)
timeFrame: Up to 36 months
measure: Duration of Response (DOR)
timeFrame: Up to 36 months
measure: Progression-Free Survival (PFS)
timeFrame: Up to 36 months
measure: Overall Survival
timeFrame: Up to 36 months
measure: Maximum observed concentration (Cmax) of ABOD2011
timeFrame: From first dose of ABOD2011 through to 28 days after last dose of investigational product
measure: Area under the concentration-time curve (AUC) of ABOD2011
timeFrame: From first dose of ABOD2011 through to 28 days after last dose of investigational product
measure: Maximum observed concentration (Cmax) of IL-12
timeFrame: From first dose of ABOD2011 through to 28 days after last dose of investigational product
measure: Area under the concentration-time curve (AUC) of IL-12
timeFrame: From first dose of ABOD2011 through to 28 days after last dose of investigational product.
measure: Plasma concentration of IFN gamma
timeFrame: From first dose of ABOD2011 through to 28 days after last dose of investigational product.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Ning Li, Doctor
role: PRINCIPAL_INVESTIGATOR
References: