Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China
Location status: Recruiting
Location contact
Ning Li
CONTACT
Ning Li
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05392699
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
Beijing, China
Location status: Recruiting
Ning Li
CONTACT
Ning Li
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
human single chain IL-12 mRNA administered as specified in the treatment arm with injection once only
human single chain IL-12 mRNA administered as specified in the treatment arm with injection once per week for 3 weeks
Time frame: From first dose to Day 28
Number of Participants Experiencing dose-limiting toxicities (DLTs)
Time frame: From signed ICF until the date of last visit or start new antitumor therapy, whichever comes first, assessed up to 36 months
Number of Participants Experiencing Adverse Events (AEs)
Time frame: From signed ICF until the date of last visit or start new antitumor therapy, whichever came first, assessed up to 24 months
Number of Participants Experiencing Severe Adverse Events (SAEs)
Time frame: Up to 36 months
Overall Response Rate (ORR)
Time frame: Up to 36 months
Disease Control Rate(DCR)
Time frame: Up to 36 months
Duration of Response (DOR)
Time frame: Up to 36 months
Progression-Free Survival (PFS)
Time frame: Up to 36 months
Overall Survival
Time frame: From first dose of ABOD2011 through to 28 days after last dose of investigational product
Maximum observed concentration (Cmax) of ABOD2011
Time frame: From first dose of ABOD2011 through to 28 days after last dose of investigational product
Area under the concentration-time curve (AUC) of ABOD2011
Time frame: From first dose of ABOD2011 through to 28 days after last dose of investigational product
Maximum observed concentration (Cmax) of IL-12
Time frame: From first dose of ABOD2011 through to 28 days after last dose of investigational product.
Area under the concentration-time curve (AUC) of IL-12
Time frame: From first dose of ABOD2011 through to 28 days after last dose of investigational product.
Plasma concentration of IFN gamma
Contact information is provided by the study sponsor or research team.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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